Narval CC
Mandibular repositioning device
Dental practitioner guide
Treatment of snoring and obstructive sleep apnoea with Narval CC.
A custom-made mandibular repositioning device.
ResMed.com/Narval
Join global leaders
in sleep and respiratory
medicine
ResMed is a world leader in the development, manufacture
and distribution of medical equipment to treat sleep-disordered
breathing (SDB) and other respiratory disorders.
1989: ResMed founded in Sydney
(AUS)
2002: Narval founded in Lyon (FR)
Formed in 1989, ResMed now employs a global team of over
4,000 staff and operates in almost 100 countries via subsidiaries
and independent distributors with manufacturing sites in
Australia, Europe, Singapore and the USA.
ResMed’s ambition is to raise awareness of the inherent dangers
of undiagnosed and untreated SDB, and to improve quality of life
for people with SDB and respiratory disorders.
In 2002, the development of Narval CC began in Lyon,
France. Narval CC is a high-precision, custom-made mandibular
repositioning device (MRD) that combines innovation with
computer-aided design and manufacturing (CAD/CAM) technology
to produce a light, flexible and durable appliance. ResMed
acquired Narval in 2009 and initiated further product, clinical
and commercial development. Since then, Narval CC has been
embraced by dental practitioners worldwide.
Recent developments in sleep therapy have created
opportunities for dental practitioners to play a vital role in the
treatment of sleep apnoea. Your dental practice could become
part of a multi-disciplinary network of specialists that includes
sleep physicians, pulmonologists, neurologists and neuropsychiatrists.
While obstructive sleep apnoea (OSA) is a medical condition,
MRD treatment requires dental expertise to ensure proper
patient selection, diagnosis and treatment.
We hope you will become one of many practitioners around the
world offering Narval CC to your patients.
2
2009: Narval acquired by ResMed
2013: ORCADES clinical study
2015: Five Narval CC design options available
Table of Contents
Introduction to sleep-disordered breathing
What is sleep-disordered breathing (SDB)?_____________________________________________
4
What is obstructive sleep apnoea (OSA)?______________________________________________
4
Validated treatment options for sleep-disordered breathing_______________________________
5
Narval CC: ResMed's custom-made MRD
Mandibular Repositioning Device: how it works_________________________________________
6
American Academy of Sleep Medicine (AASM) Guidelines for custom-made MRDs_________
7
Narval CC indications________________________________________________________________
7
What to look for in a custom-made MRD_______________________________________________
8
Narval CC benefits and features______________________________________________________
8
Narval CC design guide______________________________________________________________
9
Multi-disciplinary network___________________________________________________________ 10
Narval CC: Clinical protocol of care
Documented clinical benefits and excellent compliance_________________________________ 11
Patient identification and contraindications____________________________________________ 12
Clinical protocol___________________________________________________________________ 13
Fitting and instructing your patient___________________________________________________ 20
Adjusting retention_________________________________________________________________ 21
Titration and patient compliance_____________________________________________________ 22
Adjusting protusion________________________________________________________________ 23
Selecting the right connecting rods__________________________________________________ 23
Frequently asked questions_________________________________________________________ 24
3
Introduction
to sleep-disordered breathing
What is sleep-disordered breathing (SDB)?
SDB describes a number of nocturnal breathing disorders, including:
•O
bstructive sleep apnoea (OSA), which is the most
common form of SDB. The muscles at the back of the throat
relax so much that they obstruct the upper airway, interrupt
breathing and cause mini awakenings called arousals.
• Central sleep apnoea (CSA), which occurs when the
brain stops sending signals to the respiratory system.
The airway remains open but breathing stops.
• Nocturnal
hypoventilation (NH), which is manifested
by a reduced rate and depth of breathing due to a loss
of muscle tone during sleep, especially during rapid eye
movement (REM) sleep. It occurs in patients with chronic
obstructive pulmonary disease, neurological impairments,
restrictive diseases (e.g. scoliosis) and obesity.
•C
heyne–Stokes respiration (CSR), which is characterised
by crescendo and decrescendo periods of breathing
accompanied either by five or more central apnoeas or
hypopnoeas per hour of sleep or by a cyclic crescendo and
decrescendo change in breathing amplitude that lasts at
least ten minutes.
What is obstructive sleep apnoea (OSA)?
OSA is a partial or complete collapse of the upper airway caused by the relaxation of muscles controlling the soft palate and
tongue. Patients suffering from OSA experience apnoeas, hypopnoeas and flow limitations.
An apnoea is the cessation of airflow for ≥10 seconds.
A hypopnoea is a decrease in airflow lasting ≥10 seconds with a 30% reduction in airflow and at least 4% oxygen desaturation
from baseline.
Flow limitation is the narrowing of the upper airway and an indication of an impending upper airway closure.
Healthy patient
Airway state
(airway open)
Untreated OSA patient
(airway closed – Apnoea)
Pharynx is collapsed:
airflow is blocked
OSA pathology: apnoea during sleep
4
Narval CC™
Introduction to sleep-disordered breathing
Validated treatment options for sleep-disordered breathing
Continuous positive airway pressure (CPAP) and custom-made mandibular repositioning devices (MRD) are the two validated
and most frequently prescribed treatments for OSA.
• CPAP prevents collapse of the airway by maintaining positive airway pressure during sleep.
2015
ResMed Air Solutions
• An MRD is an oral appliance that holds the lower jaw in a forward position to open the airway during sleep.
MRDs are designed to treat OSA and snoring by preventing the airway from becoming obstructed during sleep, in a similar
way to CPAP devices. However, they do this by protruding the lower jaw, which helps to:
• open up the space behind the tongue
• increase the tension on the soft palate which, when relaxed, causes snoring
• increase the upper airway calibre at most levels, especially at the oro-pharynx1
• reduce the collapsibility of the upper airway.2
Narval CC five design options
Incisor full coverage
Facial band with cap
Facial band
Palatal/Lingual
band with cap
Palatal/Lingual band
5
Narval CC:
ResMed's custom-made MRD
Mandibular Repositioning Device: how it works
MRDs hold the lower jaw in a forward position during sleep. In doing so, they:
• create an anterior movement of suprahyoid and genioglossus
muscles. The suprahyoid muscle widens the oesophagus
during swallowing and the genioglossus muscle depresses
and protrudes the tongue;
• decrease the gravitational effect of the tongue;
• stretch the soft palate;
• stabilise the mandible to the hyoid bone, which increases
upper airway muscle activity in the lateral pharyngeal crosssectional area and helps to prevent snoring and obstructive
apnoeas. The hyoid bone attaches to the muscles of the floor
of the mouth and the tongue above, to the larynx below, and
to the epiglottis and pharynx behind.
Without MRD: pharynx is collapsed
and airflow is blocked
With MRD: pharynx is open
and air flows freely
Untreated
Untreated
OSA patient
OSA patient
Narval Narval
CC™ CC™
atient
althy patient
airway
pen) open)
(airway (airway
closed –closed
Apnoea)
– Apnoea)
Narval creates less stress on the TMJ
With Narval CC, the posterior rotation axes are elevated. This places the connecting rods parallel to a patient's jawline and allows
the retention force to work along the occlusal plane. In their biomechanical simulation study, Cheze et al3 showed that this
articulation creates 10% less stress on the temporomandibular joint (TMJ) than a conventional compression-based device and
sustains mouth-closing and physiological breathing during sleep.
Conventional compression-based device
6
Narval CC device
Narval CC: ResMed's custom-made MRD
American Academy of Sleep Medicine (AASM)
Guidelines for custom-made MRDs
4
Clinical practice guideline for the treatment of obstructive sleep apnoea and snoring
with oral appliance therapy: an update for 2015
An American Academy of Sleep Medicine and American Academy of Dental Sleep Medicine Clinical Practice Guideline.
We recommend that sleep physicians prescribe oral appliances, rather than no therapy, for adult patients who request treatment
of primary snoring (without obstructive sleep apnoea). STANDARD
We recommend that sleep physicians consider prescription of oral appliances, rather than no treatment, for adult patients with
obstructive sleep apnoea who are intolerant of CPAP therapy or prefer alternate therapy. STANDARD
When oral appliance therapy is prescribed by a sleep physician for an adult patient with obstructive sleep apnoea, we suggest that
a qualified dentist use a custom, titratable appliance over non-custom oral devices. GUIDELINE
We suggest that qualified dentists provide oversight—rather than no follow-up— of oral appliance therapy in adult patients with
obstructive sleep apnoea, to survey for dental related side effects or occlusal changes and reduce their incidence. GUIDELINE
We suggest that sleep physicians conduct follow-up sleep testing to improve or confirm treatment efficacy, rather than conduct
follow-up without sleep testing, for patients fitted with oral appliances. GUIDELINE
We suggest that sleep physicians and qualified dentists instruct adult patients treated with oral appliances for obstructive sleep
apnoea to return for periodic office visits—as opposed to no follow-up—with a qualified dentist and a sleep physician. GUIDELINE
Narval CC indications
Narval CC is a custom-made device, available under medical prescription and intended to treat snoring and/or OSA in adults.
In case of severe apnoea, Narval CC is recommended in second intention after CPAP refusal or failure or for patients who are
non-compliant with CPAP.
7
Narval CC: ResMed's custom-made MRD
What to look for in a custom-made MRD
• Optimal treatment of OSA is based on efficacy (significantly
reducing Apnoea–Hypopnoea Index (AHI) and symptoms)
and compliance (wearing an MRD as often and for as long
as possible).
• Efficacy and compliance are usually reported in clinical
studies.
• Check whether these factors have been documented
for the device you’re considering for your patients.
• An MRD should be thin, light, discreet and comfortable.
• It should precisely capture oral anatomy to seamlessly find its
place in your patient’s mouth. It should also allow for natural
jaw movement to help with acceptance and compliance.
• An MRD should be robust and durable enough to efficiently
hold your patient’s mandible in a forward position in the long
term. Protrusion should be easily adaptable, and in small
increments to ease the titration process and provide the
best balance between efficacy and comfort.
With its innovative design and advanced CAD/CAM
technology, Narval CC is the next generation custommade MRD, created to meet all these expectations and
more.
Narval CC benefits and features
Innovative design and made using 3-D printing technology.
Comfortable
Precise
Innovative traction-based device
CAD-enhanced customisation
• 10% less stress on the TMJ compared
to compression-based devices.3
• Designed to sustain closed mouth
and lip seal for physiological
breathing during sleep.3
• Several design variations
available to respect patients'
anatomical constraints.
• Proprietary software gives intimate
contact with teeth for an innovative
custom fit.6
• Optimised inner surface for faster
seating.
• Parallel occlusal planes for even
distribution of masticatory force.
Pri
m
ar
Denta
l pPr
ac
tit
i
ideerr
vvid
pPrroo
rree
cCaa
y
er
on
Natural
Thin and light
• High patient compliance5
thanks to a thin, light design.
•S
mall volume for optimised
tongue space.
•R
ounded edges and
counter-sunk connecting rods
to minimise risk of irritation.
CAM-optimised material
• Laser-sintered, biocompatible7
polymer for verified durability.8
• Designed to be strong
enough to use in patients
with bruxism.9
Slee
p specialist
Freedom
Patented articulation
• Possible to talk, drink and move the jaw naturally.
• Rapid, easy and precise titration thanks to the 0.5mm
increment connecting rods
8
Durable
Narval CC: ResMed's custom-made MRD
Narval CC: design guide
Narval MRDs are mainly produced with a "facial band" design. This design offers minimised volume and easier insertion.
However, this design is only possible for dental morphologies with a sufficient level of posterior retention. If the teeth are not
sufficiently retentive, an incisor full coverage design or a band with cap design will be created in order to increase the rigidity
and retention of the splints. Moreover, thanks to the CAD/CAM technology, it is possible to choose from five design variations
to better meet the specific needs and anatomical constraints of each patient.
Each design can be applied independently on the lower splint and on the upper splint.
Without any design specifications on the order form, the Narval MRD will be designed as a facial band unless the dental
morphology of the patient requires to apply a different design.
Low
retentive
teeth
Proclination
Retroclination
Overbite
Significant
overlap
of the
incisors
Frenelum
close
to the
margins
Facial band
-
-
•
•
•
-
Facial band
with cap
•
-
•
-
-
-
Incisor full coverage
•
-
-
-
-
-
Lingual / Palatal
band with cap
•
•
-
-
-
•
Lingual / Palatal
band
IMPORTANT: Please note that Narval CC does not take retention from the anterior teeth.
-
•
-
•
-
•
Design options
9
Narval CC: ResMed's custom-made MRD
rval
Na
ed
Communication between specialists is key to treating your
patients and monitoring progress to ensure efficacy.
Re
s
t
M
When you introduce Narval CC to your practice, you become
part of a multi-disciplinary sleep network dedicated to helping
OSA patients.
Sleep sp
eci
ali
s
Multi-disciplinary network
Patient
De
er
ntal p
ractition
Healthcare provider
assessment
Sleep analysis
Dental practitioner
Identified with OSA
Oral pathology
assessment
Identified with OSA
symptoms
Prescribed MRD
Referred to sleep lab
Referred to dentist
Take a dental impression
Dental and sleep
follow up
Titration and sleep
monitoring to ensure
efficacy
Narval CC supplied and
fitted
Dental protocol of patient care
It takes just a few appointments to identify a patient, fit them with Narval CC and monitor their progress.
1st appointment
2nd appointment
3rd appointment
On going follow-up
Validate absence
of dental or TMJ
contraindications
Fit MRD
Adjust mandibular
advancement (titration)
according to impact
on symptoms
(sleepiness,
snoring, fatigue)
Adjustment
Check for side effects
Changes to occlusion
Take impressions
Record patient’s
protrusion
10
Adjust MRD for
pre-set protrusion
Retention
Hygiene
Narval CC: ResMed's custom-made MRD
Documented clinical benefits and excellent compliance
ResMed is the promoter of ORCADES, the largest prospective multicentre study ever performed on severe apnoea patients treated
with mandibular advancement. The study is following 369 patients for 5 years and aims to provide solid clinical evidence regarding
the benefits of the Narval CC in the treatment of OSA in current practice. In this cohort, 312 patients have been treated with
CAD/CAM Narval and 57 with non-CAD/CAM Narval, allowing analysis by sub-group.10 The interim results confirm excellent
outcomes in line with previous studies most notably Geraads et al11 and Vecchierini et al5.
Superior efficacy on AHI
• 79% success rate* (vs. 61% with a non-CAD/CAM Narval,
p = 0.0031) irrespective of OSA severity
• 66% complete response* (vs. 49% with a non-CAD/CAM,
p = 0.0017)
*Success is defined as ≥ 50% decrease in AHI while complete response is
defined as AHI < 10.
MRD efficacy at 3-6 months follow-up
100%
p = 0.0031
80%
79%
60%
p = 0.0017
80%
70%
66%
61%
49%
38%
40%
26%
20%
Superior efficacy on symptoms
• 3.4
points of reduction in the Epworth score after
3-6 months (p < 0.0001)
• 62%
of patients with an initial Epworth score > 10
are no longer sleepy after 3-6 months
• Complete
disappearance of loud snoring in 89%
of patients
0%
Success rate
Excellent tolerance
• Few
patients discontinued MRD therapy
for side effects (8%)
• Most
of side effects are common and minor
AHI < 15
CAD/CAM
Evolution of snoring
PSG data
Patient self-reporting
150 p < 0.0001
100%
100
p < 0.0001
60%
40%
50
20%
20%
0%
100%
80%
80%
40% p < 0.0001
• 86%
of all patients wear their appliance every night
• The average usage is 6.7 hours/night and 6.7 nights/week
AHI < 10
Non-CAD/CAM
60%
Excellent compliance
AHI < 5
0
Snoring
duration
% sleep time
Snoring
number/hour
of sleep
0%
Daily
snorers
Loud
snoring
Loud
snoring
Evolution of quality of life (QSQ)
8
p < 0.0001
p < 0.0001
p < 0.0001
p < 0.0001
Sleepiness
Diurnal
symptoms
Noctural
symptoms
Emotions
p < 0.0001
6
4
2
0
Social
interactions
11
Narval CC:
Clinical protocol of care
Patient identification and contraindications
Precautions
Before prescribing Narval CC, you should check for relevant
issues in your patient's medical history, such as respiratory
disorders, asthma and breathing problems. Any such problems
should be referred to the appropriate healthcare provider before
treatment.
Contraindications
It will be impossible to equip your patient if they:
• have central sleep apnoea;
• have severe respiratory disorders (other than OSA);
• have loose teeth or advanced periodontal disease;
• are less than 18 years of age;
• have a completely edentulous arch;
• have a complete lower denture (not an overdenture);
• have
short teeth and/or insufficient undercuts to retain the
device.
Important
Patient identification: oral and prosthetics
examination
To establish whether a patient is suitable for MRD
treatment, you must perform a dental, periodontal,
prosthetic and TMJ examination.
TMJ examination
Any TMJ or other TMJ disorder pain must be further
assessed by the patient’s physician.
Periodontal examination
The following dental issues must be treated by the
patient’s regular dentist before MRD treatment:
• Periodontal disease;
• Cysts and mouth ulcers;
• Teeth that need to be extracted;
• Prosthodontics, such as a crown or bridge;
• Orthodontics.
12
Anchoring value
Latest dental sleep guidelines12,13 of OSA management
with MRD therapy recommend a sufficient anchoring
value and an adequate retentive morphology of teeth.
The dental sleep specialist should check if the teeth
(natural or dental implant) anchoring value and morphology
are sufficient to ensure the efficacy of MRD without
significant side effect of treatment.
If there are no contraindications and you have valid
informed patient consent, you can proceed with treatment
according to the clinical protocol described in the next few
pages.
Narval CC: Clinical protocol of care
Clinical protocol
Before placing an order for Narval CC, please contact your local ResMed Narval representative to go through the procedure.
Please also note that clinical requirements may differ from practice to practice.
In order to achieve a consistent fit with each custom-made Narval CC, we need accurate dental impressions OR plaster models.
We also require a bite registration in desired protrusion OR measurements in maximum protrusion.
Dental impressions
The more precise the impressions, the more natural and comfortable the MRD will be for your patient. If an impression is damaged,
inadequate or inaccurate, it will not provide proper fit and retention. By taking extra care to provide precise impressions, you’ll save
yourself (and your patients) time in the long run.
Examples of good impressions
✔
A complete well defined upper and lower impression of all visible teeth especially the molars. Each tooth is well defined with at least
5 mm of material above the gingival margin. A good homogeneous mixture of the material:
✔
✔
✔
no powder, bubbles, colour differences
no deformation, pulls or tears
no delamination from the tray
Upper
Lower
13
Narval CC: Clinical protocol of care
Examples of unusable impressions
✘
Deformation of the impression due to insufficient setting time of the
material.
The gingival margins are not visible and a portion of a tooth
is missing.
The impression was moved before the material had time to set
causing significant deformation in the anterior region.
The impression shows a lack of depth and width of material and the
impression failed to capture the posterior molar.
The impression material was not mixed properly and shows evidence
of bubbles and lack of material in the tray
The impression material is delaminating from the tray and has excess
material in the labial yet is to shallow in the occlusion region
14
Narval CC: Clinical protocol of care
Tips and tricks:
The dental impressions must:
• C
onsider using Rim-Lock® impression trays which allow for
full impression of gingival sulcus and posterior molar area.
• Accurately depict both jaws.
• Consider using a light body polyvinyl siloxane (PVS) as an
impression material to capture the necessary details. Use
a digital timer to check the material has enough time to set
fully.
• Dry
excess saliva from occlusal surfaces.
• Choose an impression material that is not affected by
transport. ResMed recommend non-compressive silicon
for long distance and/or weekend transportation. Alginate
should only be used for short distance transportation.
Using a high quality PVS impression material, as you
would for making a crown or bridge impression, allows for
multiple pours.
• If using alginate impression material please use a tray
adhesive and/or a specific alginate impression tray.
• Include full sulcal depth (at least 5mm to the margin).
• Include the most posterior tooth in each arch and, if
possible, capture the distal surface, including third molars.
• Capture details like occlusal surface textures, gingival
margins, frenula and every bit of tooth shape, similar to a
partial denture impression.
• Be taken with dentures in place (if any) and show the
bottom of the sulcus in the full dental arch.
• Be
disinfected before shipment.
• If
the patient has (a) pontic(s) and if :
- They wear it/them during the night , the impressions must
be taken with the pontic(s) in place. Please do NOT send
the pontic(s) to ResMed. It is not required.
-They do not wear it/them during the night, the anchoring
value of the remaining teeth must be sufficient. Nevertheless,
if the Narval MRD is not retentive enough, new impressions
with the pontic(s) in place could be a possible solution and
can be requested, in which case the patient will need to
wear the pontic(s) everytime the Narval MRD is used.
Note: Impressions may be discarded following the production
process.
Plaster models
If you send plaster/stone models, please:
• ONLY use a Type IV high strength material, low expansion
crown and bridge die stone that produces smooth, hard
and accurate surfaces.
• Prepare the plaster model in order to:
- ensure that all the teeth can be read by the scanner used
by our production facility
- provide utmost accuracy (e.g. remove bubbles).
• Use plaster that can be scanned by CAD/CAM systems
(matt and light colour).
15
Narval CC: Clinical protocol of care
Measurements
If you can’t provide a bite registration in desired protrusion, we will need the measurements in maximum protrusion.
Please measure and indicate on your prescription order form:
• Your patient's maximum mandibular advancement from teeth 11 to 41 from incisal edge of the lower to the incisal edge of the
upper. In order to do so, ask the patient to move the lower jaw forward, then place the ruler against the incisal surface of tooth 11
and take the measure directly above the incisal surface of tooth 41.
• The maximum mandibular advancement is usually 10 mm. It is also linked to the maximum jaw opening and can be verified by
doing the following calculation: maximum opening (in cm) x 2 = maximum advancement (in mm). For example, if the maximum
opening is 5 cm, then the maximum advancement should be 5 x 2 = 10 mm.
• Any lateral deviation of the mandible in maximum protrusion (the direction and amount, measured at the incisors' mid-line).
Maximum mandibular
advancement as depicted
on the order form.
Lateral deviation as depicted
on the order form.
Consider providing a bite in centric occlusion using material of your choice in case of special (prognathy, retrognathy) and/or unstable
occlusion.
The initial mandibular protrusion will be set at approximately 60% of maximum advancement. The vertical dimension will be
minimised so as to ensure no posterior contact during advancement. (Please pay attention to the curve of Spee, which can lead
to posterior contacts during advancement). You may find it beneficial to have the patient move the jaw to maximum protrusion a
number of times before taking your final measurements or bite recording.
If you think that measurements and impressions will not be enough to exactly depict your prescription, please also send any useful
drawings or photos.
16
Narval CC: Clinical protocol of care
Bite registration
A plaster model in centric occlusion
The same model but with a wax bite record in desired protrusion
We need the patient’s bite registration in the desired protrusion in a material of your choice.
• Use wax bite or preferably a positioning device, like a ProGauge or George Gauge, with a heavy body or fast-setting PVS bite
registration material. If using wax, please bear in mind that it distorts easily.
• Consider starting your patient’s therapy at approximately 60% of the maximum protrusive range, as long as it is comfortable
for the patient. Narval CC has a wide range of adjustment, so you do not need to begin with an aggressively protruded posture.
• Remember to check posterior clearance and be careful of a deep curve of Spee or angled third molars, which may create
clearance problems in protrusion.
•P
lease disinfect bite registrations before sending them to ResMed or your dental laboratory.
A plaster model in centric occlusion
The same model but with the bite recorded with a George Gauge in
desired protrusion
Vertical dimension:
• ResMed can optimize the vertical dimension so as to ensure no posterior contact during advancement. If you would like this
option, please tick “Please optimise vertical dimension” on the order form.
• Tick “Please reproduce the vertical dimension” on the order form if you would like ResMed to reproduce the vertical dimension
recorded by your bite impression. In that case the bite registration should be at least 4mm thick. If a significant vertical
dimension adjustment is necessary (additional opening of 2°, which corresponds to approximately 3 mm), you will be contacted
before production starts.
• Low retention might make it necessary to cover more posterior teeth and increase the smallest achievable vertical dimension.
Further information can be found under the section 'Vertical dimension and molar coverage.
17
Narval CC: Clinical protocol of care
Vertical dimension and molar coverage
If the dentist provides measurements in maximum protrusion, the VD will be optimized differently based on option selected
in the order form:
If selected option is:
✔
The Vertical Dimension will be:
The following will be done:
You will be contacted if/unless:
INCLUDE all the
molars
The VD will be optimized as low
as possible: 3-4mm minimum
at the molars to ensure enough
material resistance of the splints
and not to exceed 10mm between
incisors.*
The VD will be optimized as low
You will be contacted if:
as possible: 3-4mm minimum
• at least a partial coverage on the
at the molars to ensure enough
last molars with a VD lower than
material resistance of the splints
10mm can’t be respected.
and not to exceed 10mm between
incisors.*
INCLUDE all the
molars
The VD will be optimized as low
as possible: 3-4mm minimum
at the molars to ensure enough
material resistance of the splints
and not to exceed 10mm between
incisors.*
The coverage will be by default:
• on the second molars on the
bottom teeth
• on the first molars on the upper
teeth
• with a minimum on the second
premolars to avoid exceeding
10mm between incisors
• with a maximum on the last
molars in case of low retention
You will not be contacted unless:
• you requests a specific posterior
coverage level that can’t be
respected
• the distance between incisors is
exceeding 10mm*
If the dentist provides a bite registration in desired protrusion, the VD will depend on selected options in the order form:
If selected option are:
✔
OPTIMIZE the VD
REPRODUCE
the VD
✔
INCLUDE all the
molars
✔
OPTIMIZE the VD
REPRODUCE
the VD
INCLUDE all the
molars
OPTIMIZE the VD
✔
REPRODUCE
the VD
✔
INCLUDE all the
molars
OPTIMIZE the VD
✔
REPRODUCE
the VD
INCLUDE all the
molars
The Vertical Dimension will be:
The following will be done:
You will be contacted if/unless:
The VD will be optimized as low
as possible: 3-4mm minimum
at the molars to ensure enough
material resistance of the splints
and not to exceed 10mm between
incisors.*
A partial coverage (at least a few
mm of material sitting over the
last teeth) may be needed to
reduce the VD.
You will be contacted if :
• at least a partial coverage on the
last molars with a VD lower than
10mm can’t be respected.
The VD will be optimized as low
as possible: 3-4mm minimum
at the molars to ensure enough
material resistance of the splints
and not to exceed 10mm between
incisors.*
You will be contacted if:
The coverage will be by default
• you request a specific posterior
on the second molars on
level of coverage that can’t be
the bottom teeth on the first
respected
molars on the upper teeth with
• the distance between incisors is
a minimum on the second
over 10mm*
premolars to avoid exceeding
10mm between incisors
with a maximum on the last
molars in case of lack of retention.
The VD will be reproduced if the
bite registration is at least 4mm
thick at the molars.
If the VD of the bite can’t be
respected, the VD will be
optimized following the VD rules
explained before (VD increased
up to 3mm or reduced down to
10mm at incisors with a 0-3mm
decrease).
If the VD of the bite can’t be
respected, First the coverage will
be reduced to a partial coverage
(at least a few mm of material
sitting over the last teeth). If this
is still not enough, the VD will
be then exceptionally increased
between 0-3mm maximum.
You will be contacted if:
• ResMed needs to increase the VD
over 3mm
• the distance between incisors is
over 10mm*
The VD will be reproduced if the
bite registration is at least 4mm
thick at the molars.
If the VD of the bite can’t be
respected, the VD will be
optimized following the VD rules
explained before (VD increased
up to 3mm or reduced down to
10mm at incisors with a 0-3mm
decrease).
The coverage will be by default
• on the second molars on the
bottom teeth and on the first
molars on the upper teeth,
• with a minimum on the second
premolars to avoid exceeding
10mm between incisors
• with a maximum on the last
molars in case of lack of
retention.
You will be contacted if:
• ResMed needs to increase the
VD more than 3mm because of
pronounced Spee curve
• you request a specific posterior
level of coverage that can’t be
respected
• the distance between incisors is
over 10mm*
*In order to help as much as possible the patient to maintain his lips closed and to avoid mouth breathing while sleeping.
18
Narval CC: Clinical protocol of care
Prescription order form
Important
Always use the latest order form to ensure that the most up-to-date information is recorded and sent to the production
facility. Please only fill out the order form in English.
Once you have all the necessary information, please complete, sign and date the prescription order form, including your patient’s
name, your practice address and your contact details.
Ensure the patient acknowledges the data privacy statement on the back of the order form.
Send the completed order form along with:
• The disinfected impressions or stone models;
• The disinfected protrusive bite registration and/or measurements.
We will then design and manufacture Narval CC following your prescription using unique CAD/CAM technology to meet the needs
of your patient.
Example of an order form
Internal use only
DLP use only
Usage DLP
Reçu le :
Usage interne
Name :
DEP Chèq Poste TNT
Ordering instructions for Narval CC™
N° Série
Plâtre
PE
GG
Mordu
1.
FTP order # :
Date :
Order form for Narval CC
™
Before prescribing patients with Narval CCTM, you should look out for relevant issues in their medical history, such as respiratory disorders, asthma
and breathing problems, and refer them to the appropriate healthcare provider first.
PAYS
The device is contraindicated for patients
who:
- Have Central sleep apnea
- Have severe respiratory disorder (other
than OSA)
- Have loose teeth or advanced
periodontal disease
- Are less than 18 years of age
- Have a completely edentulous arch
- Have a complete lower denture (not
over-denture)
- Have short teeth, insufficient undercuts
to retain the device
Patient information / Informations patient
Name______________________________________________________________________________________________________________ First Name
Nom
 This patient was fitted with Narval CC
________________________________________________________________________________
Prénom
TM
in the past
Age
Ce patient a déjà été équipé d’une Narval CCTM
Mandatory information to supply /
ID# ________________________________________________________________________
_________________________________
Age
Informations à fournir obligatoirement
OR
BITE REGISTRATION IN DESIRED PROTRUSION
 Bite registration in desired protrusion provided
MEASUREMENTS IN MAXIMUM PROTRUSION
 Distance from incisor 11 to 41 :
_______________ mm
from end to end in max. comfortable protrusion
Mordu en propulsion souhaitée fourni
Distance entre les incisives maxillaires et mandibulaires
AND
 Please optimize the vertical dimension (ResMed recommended option)  Midline deviation

: _______________ mm
in max. comfortable protrusion
Veuillez optimiser la dimension verticale fournie par le mordu
Right
patient
Déviation des milieux inter-incisifs
OR
Droite

2.



Teeth to protect : _____________________________________
Dents à protéger
/ Particularités dentaires à nous signaler
Broken teeth :
Dents cassées
________________________________________
Future restoration (implant/crown) on teeth # : _______________________________________________________________
Restauration dentaire (implant/couronne) prévue sur dents N°:

Complete lower implant retained over-denture

Presence of pontics (see instructions on impressions)
Prothèse totale inférieure sur implant
Autre
Design preferences / Préférences de design
You can choose the design of the device for the upper and lower splints. Please indicate your preferences below, otherwise the default will be "FACIAL
BAND" or in case of insufficient an "INCISOR FULL COVERAGE" will be created. Please note that Narval CC does not take retention from anterior teeth.
 Upper / Haut
 Lower / Bas
 Please include all the molars
Facial band with cap
 Upper / Haut
 Lower / Bas
Je souhaite inclure toutes les molaires
Dentist Signature
Dentist Name :
Incisor full coverage
 Upper / Haut
 Lower / Bas
Palatal/Lingual band with
cap
 Upper / Haut
 Lower / Bas
 Please inform me if my preferences cannot be fulfilled
Je souhaite être informé si mes préférences ne peuvent être respectées
Palatal/Lingual band
Nom du dentiste
Delivery address : ______________________________________________________________________________________________________________
Adresse de livraison
IMPRESSIONS:
- The impression material chosen should not be affected by transport (non-compressive silicon would be preferred for long distance
and/or weekend transportation and alginate should only be used for short distance transportation).
 Upper / Haut
 Lower / Bas
Date
_________
Je souhaite des encoches pour élastiques
/_________ / _________
Signature
Pays
_____________________________________________________________________________________________
-
We require a full impression of gingival sulcus and posterior molar area. Impressions must be taken with dentures in place (if any) and
must show the bottom of the sulcus in the full dental arch.
-
If the patient wears a pontic during the night, please take the impressions with the pontic in place. If the patient does not wear their
pontic during the night, please ensure that the anchoring value and morphology of the remaining teeth are sufficient. In case of doubt,
please contact your ResMed approved Dental Laboratory Partner.
MODELS:
- Please ONLY use a Type IV high strength material that can be scanned by CAD/CAM systems (matt and light colour preferred),
low expansion crown and bridge die stone that produces smooth, hard and accurate surfaces.
- Ensure bubbles are not present on the teeth surface or the gingival margin and that plaster models are less than 6 months.
 Please add slots for orthodontic bands
3.
Send your order to your local ResMed approved Dental Laboratory. More info can be provided by your ResMed contact
Complete this order form and sent it out with :
Stamp
__ _____________________________________________________________________________________________________________________________ ________________________________________________________________________________________________
Country :
B - Impressions and/or plaster models
Delivery time: Please allow 3 calendar weeks from reception of your order by ResMed SAS
______________________________________________________________________________________________________________________________________________________________________________________
When sending this order form, you confirm that you have provided the following information:
MEASUREMENTS:
- Please measure the distance between the upper incisor (N°11) and the lower incisor (N°41), from end to end, in mm and in maximum
comfortable protrusion.
- Where applicable, please provide direction and distance of midline deviation in maximum comfortable protrusion.
- Consider providing a bite in centric occlusion using material of your choice in case of special (prognathy, retrognathy) and/or unstable
occlusion.
- Initial mandibular protrusion will be set at approx. 60% of maximum comfortable protrusion.
- Vertical dimension will be minimised so as to ensure no posterior contact during advancement.
Présence de stellite(s)
Other: _____________________________________________________________________________________________________________________________ _____________________________________________________________________________________________________
Facial band
The dental sleep specialist should check if the teeth (natural or dental implant) anchoring
value and morphology are sufficient to ensure the efficacy of MRD without significant side
effect of treatment.
BITE REGISTRATION:
- Provide a bite registration in desired protrusion using wax bite, or bite impression using George Gauge or a device of your choice. If you
use wax, please pay attention to the fact that wax can distort easily and requires to take extra precautions for transportation.
- You may ask ResMed to reproduce the vertical dimension recorded by your bite impression by ticking the box “Please reproduce the
vertical dimension”. In that case the bite registration should be at least 4mm thick. If a significant vertical dimension adjustment is
necessary (additional opening of 2°, which corresponds to approximately 3 mm), you will be contacted before production starts.
- ResMed can optimize the vertical dimension so as to ensure no posterior contact during advancement. If you would like this option
please tick “Please optimize vertical dimension”.
Mordu en occlusion d’intercuspidie maximale en cas d’occlusion particulière

It is necessary to perform a dental, periodontal, prosthetic and TMJ examination. The
following dental issues must be treated by the patient’s regular dentist before MRD
treatment:
- Periodontal disease
- Cysts and mouth ulcers
- Teeth that need to be extracted
- Prosthodontics – such as crown or bridge
- Orthodontics
- Temporo-mandibular pain needs to be further assessed by patient’s treating physician
as well as any other TMJ disorder.
A - Bite Registration or measurements
Left
patient
Gauche
 Please reproduce the vertical dimension recorded by the bite registration  Bite registration in centric occlusion in case of specific occlusion
Veuillez reproduire la dimension verticale fournie par le mordu
Dental particularities to be taken into account
By signing this order form, you are confirming that the patient is a good candidate for a mandibular repositioning device.
Tel : __________________________________________________________
Email : __________________________________________________________________________________________________________________________________
To ensure your order is processed, please provide all information requested and follow the ordering instructions


Your ResMed approved Dental Laboratory
Your ResMed contact
Disinfected bite registration and/or measurements
Disinfected impressions or models
Data Privacy: Personal data about the patient and the dentist is being processed for the purpose of the mandibular repositioning device production. The dentist is the data
controller and is responsible for compliance with applicable data protection law. ResMed has the role of a data processor and processes personal data on behalf of the
dentist. On request, the patient has the right to access, rectify and delete their personal data by contacting their health professional (dentist).
Manufactured & Distributed by ResMed SAS Parc Technologique de Lyon, 292 allée Jacques Monod, 69791 Saint-Priest Cedex, France
LF-R2-18 ENG v6.0
Order form is subject to changes
19
Narval CC: Clinical protocol of care
Fitting Narval CC and instructing your patient
Important
Please inform your patient that:
• N
arval CC is a comfortable and discreet MRD, but it will take a few nights to get used to it.
• Wearing the device may cause tooth movement or changes in dental occlusion, gingival or dental soreness, pain or
soreness to the TMJ, obstruction of oral breathing, excessive salivation and a dry mouth.
1
• Clean the device and separate the splints from the
connecting rods.
• Moisten the splints in water and validate proper fit.
3
• Let the patient press firmly with his fingers on the upper
splint until it’s securely in place.
You may hear an audible ‘snap’ as the device engages
the undercuts.
5
• To remove or reposition the device, simply use fingers
evenly on both sides of the mouth to disengage the splints.
Do not pull or press on the connectors to adjust
the position.
20
2
• Re-attach the connecting rods to the splints.
• Position the device in the patient’s mouth, with the upper
splint against the upper teeth.
4
• Bring the patient’s jaw forward and let him proceed in a
similar way to slide in the lower splint.
In some cases, it may be easier to insert the lower splint
first, particularly where there’s limited protrusive range.
6
• Instruct the patient not to bite down onto the splint
to insert it onto their teeth and to remove both sides
at the same time to avoid undue force on the dentition
and splint.
Narval CC: Clinical protocol of care
Adjusting retention
When retention is too high.
If you want to relieve retention on specific areas of Narval CC, you can do so chairside by simply making small
incremental adjustments and checking the device on the model or patient along the way.
1
2
• Use a scalpel to gradually remove
excess material from the inside
surface.
• Be careful with areas that engage
the undercuts (i.e. gingival margin
and interdental spaces) so as not to
remove too much material.
• If retention is still too high, proceed in
the same way with a pink-stone bur
for adjustment or a drill of your choice
at low speed.
3
• F
inish by polishing spots where
material has been removed using
a rubber bur for polishing.
• You can also use the scalpel to
remove flash created by grinding
on the appliance.
When retention is too low.
If you want to increase retention on specific areas of Narval CC, use a suitable heat source, avoiding direct flame
contact and using lateral movement while applying heat so as not to burn the splint.
4
5
6
• H
eat one side of the relevant quadrant • Squeeze the splint with your fingers to • Cool completely with compressed air.
bring the edges together.
of the device. Prefer heating the lingual
• R
eplace the splint on the plaster model
and palatal sides of the splints.
and test retention.
Do not heat the internal surfaces nor
• If retention is still too low, repeat
the edges of the splints.
the process on the other side of the
quadrant.
21
Narval CC: Clinical protocol of care
Titration and patient compliance
Important
Narval CC is a traction-based appliance. Consequently, the protrusion is increased by shortening
the connecting rods.
Titration
MRD therapy has a well proven non-linear dose response to the level of protrusion14 until the efficacy plateau is reached. This
means that the more you protrude, the more efficient the MRD will be (up to a limit - the efficacy plateau). However, as the protrusion
increases it will be less comfortable for the patient at first, as the pressure on the teeth and the TMJ articulation increases.
Titration is the process by which you’ll adjust the protrusion of the device and of the mandible to find the best balance between
efficacy and comfort.
For greater protrusion, you’ll shorten the connectors. For milder protrusion, you’ll lengthen the connectors.
Some patients respond to the initial protrusion of their appliance. In other cases you’ll need to adjust and find the right protrusion
based on your patient’s ongoing symptoms such as:
• s noring frequency and intensity;
• tiredness;
• d
aytime sleepiness and tendency to fall asleep;
• q
uality of sleep and nocturia.
Step 1. The initial protrusion is based on the information you provide with your prescription. At the fitting appointment, there
should be no sensation of muscle/TMJ pain. If there is, reduce the protrusion by replacing the connectors with longer ones until
the discomfort disappears.
Step 2. At the follow-up appointment, once the patient is used to sleeping with Narval CC, ask about symptom improvements.
If all symptoms are resolved, proceed to step 4.
Step 3. If some symptoms persist and the patient can tolerate a greater protrusion, replace the existing connectors with
shorter ones to increase protrusion. Protrusion should not be increased by more than 1mm a week. Set up a subsequent followup appointment one or two weeks later and repeat step 3 until you reach resolution of symptoms or the tolerance limit of your
patient, whichever happens first. Proceed to step 4.
Step 4. For OSA patients, inform your sleep specialist partner of your patient’s status and MRD titration.
The patient should undertake a controlled sleep recording with Narval CC to measure treatment efficacy on breathing
parameters such as apnoeas and oxygen desaturation. A controlled sleep recording is usually not required for patients with
simple snoring.
Important
• O
nce the titration process is over, it is important to schedule regular follow-ups with your patient to assess potential side
effects and to ensure efficacy in the long term.
• For OSA patients, if a satisfactory improvement in symptoms and an objective sleep recording validation cannot be
achieved post titration(s), work with your sleep specialist partner to discuss alternative treatments.
• According to the guidelines of OSA management with MRD therapy, the maximum mandible advancement capability
should be ≥ 5 mm in order to achieve optimal MRD efficacy. The patient's ability to advance the mandible can evolve
over time, especially under MRD treatment. Additionally some patients with limited mandibular advancement before
treatment initiation may benefit from MRD therapy. In any case, the dental specialist should assess the efficacy and
safety of the treatment during follow-up appointments.
22
Narval CC: Clinical protocol of care
Adjusting protusion
Protrusion should not be increased by more than 1mm a week as adjusting in larger increments may cause undue discomfort.
1
• Turn the appliance so that the
connecting rods are aligned with
the bow tie-shaped cut out on the
splint.
3
• Select the appropriate connecting
rods using the measurement guide
below.
• To increase protrusion, use a
shorter connecting rod.
• To decrease protrusion, use a
longer connecting rod.
2a
2b
• D
isconnect the lower side first, since the bow tie-shaped cut out is more visible here.
• F
irmly push inward with the base of your thumb at the top of the rod (located on
the triangle portion of the splint) to disconnect the rod from the appliance.
• Repeat for the other side of the lower tray, then for both sides of the upper tray.
4
• Hold
the connecting rod
perpendicular to the splint. Line up
the bow tie on the connecting rod
with the cut out on the splint.
5
• Click into place to re-engage the
connecting rod.
Selecting the right connecting rods
Narval CC connecting rods come in half-millimetre
size increments for precise titration.
Picking out the right connecting rods for the next
adjustment is very intuitive: they are positioned side
by side, in size order around the frame.
Size identification is quick and easy with visible size
markings on both the connecting rods and the frame.
Available in two sizes: low range and high range.
Please contact your local ResMed representative
for replacement stock.
23
Frequently Asked Questions
MRD MAINTENANCE/HYGIENE
1) How should my patient clean his Narval CC? How often?
Every morning, use a dedicated soft denture brush to clean Narval CC with water, then rinse it, dry it, and put it back into
its box. Clean it more thoroughly twice a week with an effervescent antibacterial tablet designed for orthodontic appliances
(please refer to the Instructions For Use). Orthodontic cleaning brushes and antibacterial denture cleansers are easily found
at pharmacies.
2) Which products can I recommend to clean Narval CC?
Tests show that NitrAdine® Ortho & Junior can be used to clean Narval CC device without altering its chemical or
mechanical properties. If this product is not available you can use any other cleaning tab designed for orthodontic
appliances. Tell your patient to keep their Narval CC away from chlorine based products, bleach and acetic acid (vinegar for
example), to never put the device in water warmer than 45°C / 113 °F and to never use toothpaste or mouthwash to clean
his device, as these products may be too abrasive or discolour the device (please refer to the Instructions For Use).
3) My patient's Narval CC has blackened, burnished or has green stains inside. Why?
If your patient has dental amalgam or alloy or porcelain-fused-to-metal crowns, a chemical reaction can occur with saliva and
discolour the MRD. It is impossible to get rid of these colour changes, but they don’t compromise the treatment in any way.
4) My patient’s Narval CC has a bad smell. What can be done?
Most bad odours are the result of bacteria. Bacterial build-up can only be prevented by diligent daily cleaning and good
dental hygiene. See question 1 for information on cleaning. In case of bacterial contamination, you may recommend,
exceptionally, daily intensive cleaning with NitrAdine® Ortho & Junior for two weeks.
5) Is there a product that can help me further polish my patient’s MRD?
At the end of the fabrication process, Narval CC undergoes a treatment designed to give it optimal surface finish. The only
time when polishing might be necessary is after any required touch up. Please refer to the procedure described earlier. The
use of polishing paste is not recommended as it might create irritation.
BREAKAGE/AFTER SALES
6) My patient's Narval CC is broken. What should I do?
Send it back to the lab in its storage box for investigation along with a description of what happened. If a repair is
requested, you will also need to send the plaster models back, along with the bite. Check your patient's teeth and make
new impressions if necessary. If the device is under warranty, the repair will be free of charge. If not, we will provide you
with a quote and proceed once you approve it.
7) What is the warranty offered with my patient's Narval CC?
• ResMed guarantees all Narval CAD/CAM appliances supplied to be free from defects in materials and workmanship
for a period of 24 months effective from the date of manufacture.
• Any issues with the product should be reported to ResMed within 120 days after shipment of the device by ResMed.
After that period the warranty covers only the repair of the device.
• The scope of the warranty includes the lower splint and the upper splint of the appliance. In order for the warranty
to be honoured, both splints with connecting rods, plaster models and bite registrations must be returned to ResMed.
• Any accessories provided with the appliance are under warranty for one year. After that time, replacements can be
purchased from ResMed if needed.
• The warranty does not cover damage that is not caused by manufacturing defects. Examples include design modifications
made by non-ResMed technicians, repairs caused by defective or distorted models, defective or distorted bite records,
calculus deposits, stains, smells, damage caused by a pet.
• The warranty applies to damages caused by bruxism.
• The warranty is invalidated if the patient has dental modification or restorative work during the warranty period.
• Warranty repair work may only be completed by the ResMed facility or by a certified Dental Laboratory Partner.
24
Frequently asked questions
8) A dog chewed on my patient's Narval CC / My patient has lost his Narval CC.
Please inform your patient that these situations are not covered by the warranty. If your patient requests a new device, you
need to return the device, the plaster models and the bite registration to ResMed or your dental lab. Check your patient's
teeth and make new impressions if necessary. We’ll provide you with a quote and proceed once you approve it.
9) My patient’s Narval CC has deteriorated.
Send the Narval CC back to the lab in its storage box for investigation along with a description of what happened. If a repair
is requested, you will also need to send the plaster models back, along with the bite. Check your patient's teeth and make
new impressions if necessary. If the device is under warranty, the repair will be free of charge. If not, we will provide you
with a quote and proceed once you approve it.
10) As soon as my patient opens his mouth, the Narval CC comes off.
To increase retention, try to touch it up following the procedure described earlier. If you can't obtain a satisfying result
in the mouth, try to fit it to the plaster model. If it fits the plaster model but does not fit the patient, you will need to make
new impressions and send them to the lab along with the Narval CC in its storage box for modification or new production.
If it doesn't fit the plaster model, send the device and the model back to the lab for modification or new production.
11) Narval CC does not fit my patient's teeth.
Try to touch it up following the procedure described earlier. If you can't obtain a satisfying result in the mouth, try to fit it to
the plaster model. If it fits the plaster model but does not fit the patient, you will need to make new impressions and send
them to the dental laboratory along with the Narval CC in its storage box for modification or new production. If it doesn't fit
the plaster model, send the device and the model back in its storage box to the lab for modification or new production.
12) My patient’s Narval CC was delivered along with his plaster models, on which some teeth are broken/have been
broken and glued back. Is retention impacted by this?
At the first stage of retention control, the retention of the appliance has not yet been optimised. This can be quite
demanding on plaster models and sometimes results in breakages due to friction on the plaster material during retention
tests. Breakages at the retention control stage do not have any impact on the quality of the retention of the appliance: the
teeth are carefully glued together to continue retention adjustments and optimisation through subsequent quality control
and finishing steps.
13) I have no more connecting rods. What should I do?
New connecting rods can be purchased by contacting our customer service team.
14) There is a premature posterior contact and my patient can't close his mouth once the connecting rods are in place.
You need to scrape and re-polish the contact zones. If the gap is too large, make a new bite registration and send it back
to us with the plaster model. We'll re-fabricate a Narval CC according to the patient's protrusion.
15) Narval CC is indicated for my patient but he needs dental work.
It is imperative that all dental work is completed before fitting Narval CC to a patient.
16) I need to change one of my patient's crowns. Is it possible to re-line the Narval CC?
No, it is not possible to re-line our Narval CC. If we are not able to adapt the splint(s) on the new models, we will provide
you with a quote for a new device.
17) Is it possible to add rubber bands to Narval CC?
Yes, if you require rubber bands, please indicate this on the order form. Bands will be placed on each side of Narval CC.
We'll provide the first (latex-free) packet of 100 rubber bands.
18) My patient complains that a connecting rod systematically unhooks itself.
Check that the connecting rod is of the correct size and replace it if not. Your patient might have some lateral deviation in
propulsion. This deviation should be measured and a longer connecting rod should be placed on the lateral deviation side.
Titration might have been too swift. Lightly reduce the protrusion.
Remember that an increase in protrusion should ideally be done once every two weeks, and once every week at most.
19) My patient's connecting rods get stretched after only a few nights.
Your patient might suffer from bruxism. Check that there are no problems with the articulation and provide the patient with
multiple pairs of connecting rods so he can switch them on a regular basis.
Your patient might have a lateral-deviation. See question 32.
Your patient might have a premature posterior contact. See question 14.
25
Frequently asked questions
SIDE EFFECTS/ADVERSE EFFECTS
20) My patient complains that his teeth don't engage properly when he wakes up. What should I do?
It is not unusual for patients to find it difficult to fully occlude first thing in the morning. Reactivating masticatory function
by chewing and, ideally, having breakfast should enable them to find their normal occlusion again. This sensation should
disappear after a while.
21) My patient complains of pain at the bottom of his ears.
Pain is normal at the beginning of the treatment but it should not last long after removing the MRD, and should disappear
after one month at most.
If the pain persists for more than one hour after removal, or for longer than one month, you need to evaluate the symptoms
and check the titration to make sure that the protrusion is not excessive.
22) My patient removes his Narval CC during the night because it is painful.
Pain is normal at the beginning of the treatment but it should not last long after removing Narval CC, and should disappear
after one month at most.
If the pain persists for more than one hour after removal, or for longer than one month, you need to evaluate the symptoms
and check the titration to make sure that the protrusion is not excessive.
23) My patient has trouble eating lunch because of pain caused by Narval CC.
You need to evaluate the symptoms and check the titration and make sure that the protrusion is not excessive.
24) My patient complains about having a dry mouth.
This is a common side-effect that disappears over time in most cases. Please inform your patient of this risk before they
start treatment. Some medications such as antihistamines, antidepressants or anxiolytics can cause a dry mouth. Check
the medication your patient is taking.
Is your patient breathing well through his nose? Mouth dryness can be caused by mouth breathing. See question 27.
25) My patient complains about hyper salivation.
Hyper salivation can occur at the beginning of the treatment and should disappear with time.
26) My patient complains that he has started snoring / having apnoeas again.
Replace any unstrung or stretched connecting rods with new ones of the same size then check the patient's symptoms
again and start a new titration process if necessary. Narval CC initial protrusion might not be sufficient anymore.
If so, reduce the size of the connecting rods by 1 mm, wait 15 days and check again. Check the sliding planes or the
occlusal contacts. If your patient can't close his mouth then the treatment will not be optimal.
27) My patient naturally sleeps with his mouth open. What should I do?
ResMed can install orthodontic rubber bands on Narval CC, which will force the patient to keep their mouth shut without
removing the possibility of lateral movements.
28) My patient complains that the triangles hurt the inside of his cheeks.
We may be able to redesign Narval CC and change the position of the triangles.
29) Narval CC vestibular bands hurt my patient’s labial frenulum.
With the help of a small tungsten drill that we can supply to you, you can slightly touch up the splints before re-polishing
them. Be careful not to create a V-shaped fracture initiation.
30) My patient complains that the contact of Narval CC with his buccal mucosa is creating irritation.
Irritation can result from the friction of the soft tissues against Narval CC, from the lack of saliva or from using an unsuitable
product to clean Narval CC (see question 2).
Check that your patient doesn't suffer from mouth dryness (see question 24). Check if the irritation is due to friction or use
of a non-recommended cleaning product. If not, ask your patient to seek medical advice.
31) My patient's teeth have moved since he started wearing Narval CC.
Before deciding to temporarily or permanently stop treatment with the Narval CC, re- evaluate the risk-benefit of Narval CC
treatment with your patient, taking into account his symptoms and the severity of his OSA.
32) My patient complains about pain on one side of the TMJ only.
Your patient might have some lateral deviation in protrusion. This deviation should be measured and a longer connecting rod
should be placed on the lateral deviation side. This will relieve pressure on the joint.
26
Frequently asked questions
33) My patient complains about an allergic reaction to the appliance. I have noticed that my patient has an allergic
reaction to the device.
Narval CC is manufactured in a latex-free environment and doesn't contain any resin, latex, bisphenol A or phthalate
plasticisers (specifically DEHP, DBP, BBP, DINP, DIDP, DnOP or DnHP). Its biocompatibility has been demonstrated (see
question 36).
Very rare cases of allergic reactions to the MRD have been observed. If a patient complains about an allergy,
this may be due to:
- Irritation caused by the friction of the tissues against the device, particularly in the case of dry mouth.
- Using an unsuitable product to clean Narval CC.
Check if the irritation is due to friction or a non-recommended cleaning product. If not, ask your patient to seek medical advice.
OTHER
34) Does Narval CC contain latex, bisphenol A or phtalates?
Narval CC doesn’t contain any resin, latex, bisphenol A or phthalate plasticisers (specifically DEHP, DBP, BBP, DINP, DIDP, DnOP or DnHP). It is fabricated in a latex-free environment.
35) Is Narval CC biocompatible?
The biocompatibility of Narval CC has been demonstrated by tests based on the guidance provided by ISO 10993-1:2009
(Biological evaluation of medical devices - Evaluation and testing within a risk management process).
36) Can I fit Narval CC to somebody who is under 18?
No. Narval CC is only indicated for the treatment of adults.
37) Is there an age limit for wearing Narval CC?
No, there is no limit as long as the patient or young adults who have permanent teeth and who's dentition has stabilized.
38) Is it necessary to reach maximum protrusion for Narval CC to be efficient?
No. You have to find the right balance between comfort and efficacy. If your patient’s sleep test results are good, there is no
need to further increase the protrusion.
39) What is the protrusion percentage of Narval CC when it is delivered from the lab?
Initial mandibular advancement will be set at the desired protrusion indicated by the bite registration. If the desired
protrusion was not indicated, it will be set at approximately 60% of maximum protrusion.
40) What is the recommended minimal protrusion?
According to the guidelines of OSA management with Narval CC therapy, the maximum mandible advancement capability
should be ≥ 5 mm in order to achieve optimal efficacy. The patient's ability to advance the mandible can evolve over time,
especially under MRD treatment. Additionally some patients with limited mandibular advancement before treatment
initiation may benefit from MRD therapy. In any case, the dental specialist should assess the efficacy and safety of the
treatment during follow-up appointments.
41) Do I have to measure lateral movements (diductions)?
No. Only the lateral deviation while in maximum protrusion needs to be measured.
42) What is Narval CC made of?
Narval CC is mainly made of Polyamide 11 and laser-sintered Polyamide 12.
43) Is it possible to make a MRD in anticipation of a future implant or crown?
Yes it is possible if you indicate on the order form on which tooth/teeth the dental restoration is planned. In this case,
material will be added during the design phase. Nevertheless, ResMed cannot guarantee a perfect fit and retention once
the implant/crown is placed.
44) What are the advantages and disadvantages of including all molars in the splint? Including all the molars can help prevent over-eruption of teeth and can help increase the retention. Nevertheless, including
all the molars may lead to increase the vertical dimension especially in case of pronounced Spee curve. (please refer to the
section on Vertical Dimension for more details)
45) The connecting rods pop-off. What can be the cause? What can be done?
- The titration may have been too fast, in which case you may consider reducing it and increase it in smaller increments.
ResMed recommends to increase protusion by a maximum of 1mm every 2 weeks.
- The sliding planes may need to be stabilized (ensure contact and remove irregularities) especially in case of premature
posterior contacts
- Check the presence of a latero-deviation during protrusion and adjust the size of the connecting rods accordingly
- In case of a bruxer, the rods may need to be changed more frequently.
27
Help your patients get the sleep they deserve!
Contact your local ResMed representative or email [email protected] today.
For more information, visit ResMed.com/Narval
References
1 Cistulli P. et al, Treatment of snoring and OSA with mandibular repositioning appliances. Sleep Med Reviews
2004; 8(6):443-457.
2 AT Ng, Effect of oral appliance therapy on upper airway collapsibility in obstructive sleep apnoea. Am J Respir
Crit Care Med 2003; 1618(2):238-241.
3Cheze et al. Impact on temporomandibular joint of two mandibular advancement device designs. ITBM-RBL
2006; 27:233-237. Biomechanical study.
4 American Academy of Sleep Medicine Guidelines, Update 2015.
5 Vecchierini et al. Efficacy and compliance of mandibular repositioning device in obstructive sleep apnoea
syndrome under a patient-driven protocol of care, Sleep Medicine 9 (2008) 762–769. 45 days follow up of 35
mild to severe OSA patients.
6 Innovative custom-fit that doesn’t rely on deformation to create retention.
7 Biocompatibility demonstrated by tests based on the guidance provided by ISO 10993-1:2009 (Biological
evaluation of medical devices – Evaluation and testing within a risk management process.
8 Data on file, confidential : Narval CC Aging Test and Material Degradation Assessment.
9Data on file, confidential – Computer mechanical strength simulation study – Narval splints are able to
withstand compression forces superior to 500N.
ResMed SAS
Parc Technologique de Lyon
292 allée Jacques Monod
69791 Saint-Priest Cedex France
10MF Vecchierini et al. A custom-made mandibular repositioning device for obstructive sleep apnoea-hypopnoea
syndrome: the ORCADES study Sleep Med. 2015 Jun 29. pii: S1389-9457(15)00827-8. doi: 10.1016/j.
sleep.2015.05.020
11Geraads et al. First intention management of obstructive sleep apnoea syndrome (OSAS) by custom-made
mandibular advancement device: The medium-term results. Prospective study by the General Hospital
Pneumologists College (CPHG), Rev Pneumol Clin. 2010; 66(5):284-92. 1 year follow-up of 129 mild to severe
OSA patients.
12Ramar, Kannan, et al. "Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring
with Oral Appliance Therapy: An Update for 2015." Journal of clinical sleep medicine: JCSM: official
publication of the American Academy of Sleep Medicine 11.7 (2014): 773-827.
13Bettega, G., et al. "[Mandibular advancement device for obstructive sleep apnea treatment in adults. July
2014]." Revue de stomatologie, de chirurgie maxillo-faciale et de chirurgie orale 116.1 (2015): 28-57.
14Aarab et al. Effects of an oral appliance with different mandibular protrusion positions at a constant vertical
dimension on obstructive sleep apnoea, Clin Oral Invest 2010; 14:339-345.
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