PEDIATRIC/CRANIOFACIAL
A 12-Year Anthropometric Evaluation of the
Nose in Bilateral Cleft Lip–Cleft Palate Patients
following Nasoalveolar Molding and Cutting
Bilateral Cleft Lip and Nose Reconstruction
Judah S. Garfinkle, D.M.D.,
M.S.
Timothy W. King, M.D.,
Ph.D.
Barry H. Grayson, D.D.S.
Lawrence E. Brecht, D.D.S.
Court B. Cutting, M.D.
Portland, Ore.; Madison, Wis.; and
New York, N.Y.
Background: Patients with bilateral cleft lip– cleft palate have nasal deformities
including reduced nasal tip projection, widened ala base, and a deficient or
absent columella. The authors compare the nasal morphology of patients
treated with presurgical nasoalveolar molding followed by primary lip/nasal
reconstruction with age-matched noncleft controls.
Methods: A longitudinal, retrospective review of 77 nonsyndromic patients with
bilateral cleft lip– cleft palate was performed. Nasal tip protrusion, alar base
width, alar width, columella length, and columella width were measured at five
time points spanning 12.5 years. A one-sample t test was used for statistical
comparison to an age-matched noncleft population published by Farkas.
Results: All five measurements demonstrated parallel, proportional growth in
the treatment group relative to the noncleft group. The nasal tip protrusion, alar
base width, alar width, columella length, and columella width were not statistically different from those of the noncleft, age-matched control group at age
12.5 years. The nasal tip protrusion also showed no difference in length at 7 and
12.5 years. The alar width and alar base width were significantly wider at the first
four time points.
Conclusions: This is the first study to describe nasal morphology following
nasoalveolar molding and primary surgical repair in patients with bilateral cleft
lip– cleft palate through the age of 12.5 years. In this investigation, the authors
have shown that patients with bilateral cleft lip– cleft palate treated at their
institution with nasoalveolar molding and primary nasal reconstruction, performed at the time of their lip repair, attained nearly normal nasal morphology
through 12.5 years of age. (Plast. Reconstr. Surg. 127: 1659, 2011.)
C
hildren born with bilateral cleft lip– cleft palate have a shortened columella and an elevated, protruding premaxilla, which results
in an abnormal appearance of the nose.1,2 ConFrom the Division of Plastic and Reconstructive Surgery and
the Department of Orthodontics, Oregon Health and Science
University; the Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Wisconsin School
of Medicine and Public Health; and the Institute of Reconstructive Plastic Surgery, New York University Medical Center.
Received for publication June 24, 2010; accepted October 18,
2010.
The first two authors should be considered co–first authors.
Presented at the 64th Annual Meeting of the American Cleft
Palate–Craniofacial Association, in Broomfield, Colorado,
April 23 through 28, 2007.
Copyright ©2011 by the American Society of Plastic Surgeons
DOI: 10.1097/PRS.0b013e31820a64d7
ventional surgical techniques to repair the lip and
nose result in unnatural proportions of the columella, nostrils, and nasal tip. To improve the nasal
shape, these patients often undergo multiple operations on the nose which, in many cases, result
in a scarred columella and residual deformities of
the nose.
Disclosure: The authors certify that, to the best of
their knowledge, no financial support or benefits
have been received by any coauthor, by any member
of their immediate families, or by an individual or
entity with whom or with which they have a significant relationship from any commercial source that
is related directly or indirectly to the scientific work
reported on in this article.
www.PRSJournal.com
1659
Plastic and Reconstructive Surgery • April 2011
An alternative to these multiple surgical interventions is the use of presurgical nasoalveolar
molding. Nasoalveolar molding was first developed by Grayson and Cutting in 1988 based on the
ear cartilage molding techniques described by
Matsuo et al.3–9 In evaluating the benefits of nasoalveolar molding, Spengler et al. demonstrated
that patients who received nasoalveolar molding
had an increased columella length and nostril
height at their 10-month follow-up.10 Using photometric nasal evaluation, Liou et al. have demonstrated an increased columella length and nostril height with a 3-year follow-up in patients who
underwent nasoalveolar molding.11 Our group recently published a photometric nasal evaluation of
our patient population that demonstrated a normalized columella length at age 3 years and a
reduction in secondary revision surgery of the
nose at age 8 years.12 To date, this is the longest
follow-up study reported in the literature.
Because it is a relatively new technique, the
long-term results of nasoalveolar molding followed by primary nasal reconstruction are unknown. Although several authors have shown stable results up to age 3, and our patients appear to
have a good long-term result (Fig. 1), there have
been no studies published that have evaluated the
nasal morphology of bilateral cleft lip– cleft palate
patients undergoing nasoalveolar molding and
primary nasal reconstruction with a 12-year followup. Thus, the remaining question is: Does nasoalveolar molding, in combination with primary
nasal reconstruction, provide a long-term benefit
to the children who receive it? The purpose of this
retrospective, longitudinal study is to describe the
nasal morphology of children up to the age of 12
years who were treated at our institution with a
diagnosis of bilateral cleft lip– cleft palate and who
underwent nasoalveolar molding with primary nasal reconstruction and compare their nasal morphology to that of normal, age-matched controls.
PATIENTS AND METHODS
We performed a longitudinal, retrospective review of 77 consecutive, nonsyndromic patients
born with bilateral cleft lip– cleft palate from 1991
through 2004 who were treated with nasoalveolar
molding followed by primary nasal reconstruction
at the New York University Langone Medical Center, Institute of Reconstructive Plastic Surgery. As
shown in Table 1, not all 77 patients are included
at each time point. Because this technique is relatively new, we have fewer patients at the later time
points. In addition, because of life events such as
patients moving, there are some patients who have
been lost to follow-up. The number for each time
Fig. 1. (Left) A 1-week old infant with bilateral cleft lip– cleft palate. (Center) Nineteen-month postoperative view of the same child
at age 24 months after undergoing preoperative nasoalveolar molding and a single-stage cleft lip repair with primary nasal reconstruction. (Right) The child at age 10 years 9 months. The patient has had no additional surgery on his nose since the single-stage
cleft lip repair with primary nasal reconstruction performed at age 5 months. Note the preservation of nasal morphology between
age 2 years and age 10 years.
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Volume 127, Number 4 • Analysis of Nasoalveolar Molding Outcome
Table 1. Average Age, Point of Treatment, and Total Number of Patients Evaluated for Each Time Point
Age
Time Point
No.
Point of Treatment
Mean (SD)
Range
T1
T2
T3
T4
T5
37
34
18
16
9
Presentation
Before cleft lip repair
Before cleft palate repair
Evaluation for bone graft
Follow-up
3.22 (3.39) wk
5.56 (1.35) mo
1.01 (0.05) yr
7.04 (1.21) yr
12.57 (2.12) yr
1–14 wk
3.46–8.77 mo
0.90–1.15 yr
5.29–8.87 yr
10.08–15.48 yr
point is listed in Table 1. All patients had no other
systemic disease and no other intervention before
starting nasoalveolar molding. Nasoalveolar molding was initiated at an average age of 3.22 weeks
and lasted for an average of 21.12 ⫾ 6.02 weeks
(Table 1). All nasoalveolar molding therapy was
overseen by a single orthodontist (B.H.G.).
Presurgical Nasoalveolar Molding
The nasoalveolar molding procedure has
been described in detail previously.3– 6 Briefly, the
molding device is composed of an intraoral component and an intranasal component. Retention
is provided from tapes based on the cheeks, which
engage the intraoral plate with orthodontic rubber bands (Fig. 2). Serial adjustments to the nasoalveolar molding device are made every 1 to 2
weeks. The premaxilla is retracted and aligned with
the lateral lip and alveolar elements. Once the alveolar gaps are reduced to 5 mm, the nasal stents are
added. Nasoalveolar molding approximates the nasal dome cartilages, increases nasal tip protrusion,
increases the surface area of the nasal mucosal lining, and lengthens the columella.
Primary Cleft Lip–Cleft Palate Repair
The primary surgical repairs were performed by a single surgeon (C.B.C.) using a
Millard type lip repair and a Cutting retrograde
primary nasal reconstruction or combination
Mulliken/Cutting primary nasal reconstruction
as described previously.13–17 If the nasoalveolar
molding before treatment provided satisfactory
columella length and nasal tip shape, a simple
Cutting type retrograde primary nasal reconstruction was performed. This involved retrograde elevation of soft tissue from the surface of the lower
lateral cartilages and suturing of the domes together using polydioxanone suture. No nasal tip
skin incisions were made. If columellar length was
felt to be inadequate following nasoalveolar molding, Mulliken type nostril apex incisions were
added to the procedure to elongate the columella
using nasal tip skin and to provide direct access to
Fig. 2. (Above) Nasoalveolar molding device showing the two
nasal stents and integrated tabs that hold the elastics that are
held in tension with adhesive skin closure strips. (Below) A
close-up of the nasoalveolar molding device demonstrating the
nasal stents and the central adhesive strip on the prolabial skin.
the lower lateral cartilages for intradomal suturing. Inadequate nasoalveolar molding before
treatment was usually attributable to poor patient
compliance or more commonly a late start to the
procedure. We usually start nasoalveolar molding
at 1 week of life. Some patients started as late as age
2 to 3 months. These patients received the combined Mulliken/Cutting procedure as described
by Morovic and Cutting.16 The lip repair was performed at an average age of 5.5 months. Nylon
skin sutures were removed on postoperative day 7.
To minimize the lip scar, adhesive skin closure
1661
Plastic and Reconstructive Surgery • April 2011
strips were placed across the repair for 12 weeks.
No splinting of the nose occurred postoperatively.
At an average age of 12 months, a Bardach type
cleft palate repair with levator sling and bilateral
tensor tenopexies was performed, as described
previously.18,19 Cases performed before 1999 did
not receive the bilateral tensor tenopexy.
Nasal Impressions and Casts
Nasal impressions and casts were performed on each child. To make the nasal impression, a vinyl polysiloxane compound (Memosil 2;
Heraeus Kulzer, Inc., Armonk, N.Y.) was used and
applied onto the surface of the nose. The impres-
sion included the bilateral medial canthi as reference points, extended superiorly to the radix,
inferiorly to the vermilion border of the upper lip,
and laterally onto the cheek to include the entire
nasal ala. The material was allowed to cure before
removal from the patient. The impression was
then used to make a positive cast of the nose using
dental stone (Fig. 3). Nasal impressions were
made at five different time points as shown in
Table 1.
Anthropometric Analysis
All the anthropometric measurements were
performed directly on the nasal casts using a
digital sliding caliper by two independent ex-
Fig. 3. Nasal impressions and casts. (Above, left) The vinyl polysiloxane compound being layered
onto the surface of the nose. (Above, right) The vinyl polysiloxane impression when completed. Note
the impression included the bilateral medial canthi as reference points, extended superiorly to the
radix, inferiorly to the vermilion border of the upper lip, and laterally onto the cheek to include the
entire ala. (Below) The dental stone cast manufactured from the vinyl polysiloxane impression.
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Volume 127, Number 4 • Analysis of Nasoalveolar Molding Outcome
aminers (J.S.G., T.W.K.). For each time point,
five measurements, as described by Farkas,20
were made (Fig. 4).
1. Nasal tip protrusion (sn-prn): distance between the subnasale and the nasal tip.
2. Alar width (al-al): distance between the most
lateral points on alae.
3. Alar base width (ac-ac): distance between
the facial insertions of alar base.
4. Columella length (sn-c=): distance between
the subnasale and the nostril apex.
5. Columella width (sn=-sn=).
Statistical Analysis
Each variable was measured three times by
each examiner. Interoperator error was calculated
and was not significant. The average value and SD
were calculated. The one-sample Student t test was
used to determine whether the mean of our sample was similar to the age-matched noncleft controls from Farkas.20 A value of p ⬍ 0.05 was considered statistically significant.
RESULTS
The results of the study are shown in Figure 5
and Table 2.
Nasal Tip Protrusion (sn-prn)
The nasal tip protrusion on presentation
(time point T1) was significantly shorter in the
cleft lip– cleft palate patients when compared with
the Farkas group. However, after nasoalveolar
molding and primary nasal reconstruction, the
nasal tip protrusion was statistically longer at time
points T2 and T3 and had no statistical difference
at time points T4 and T5.
Alar Base Width (ac-ac)
The alar base width was significantly wider in
the cleft lip– cleft palate patients at time points T1
through T4 when compared with the Farkas controls. However, by time point T5, there was no
statistical difference between the two groups.
Fig. 4. Anthropometric measurements as described by Farkas
and used in this investigation. (Above) Nasal tip protrusion (snprn): distance between the subnasale and the nasal tip. (Second
row) Alar width (al-al): distance between the most lateral points
on the alae. (Third row) Alar base width (ac-ac): distance between
the facial insertions of the alar base. (Fourth row) Columella
length (sn-c=): distance between the subnasale and the nostril
apex. (Below) Columella width (sn=-sn=).
Alar Width (al-al)
The alar width was significantly wider in the
cleft lip– cleft palate patients at time points T1
through T4 when compared with the Farkas controls. However, similar to the alar base width, by
time point T5, there was no statistical difference
between the two groups.
Columella Length (sn-c=)
The columella length on presentation (T1)
was significantly shorter in the cleft lip– cleft palate
patients when compared with the Farkas group.
However, after nasoalveolar molding and primary
1663
Plastic and Reconstructive Surgery • April 2011
Fig. 5. Results of the anthropometric analysis of patients with bilateral cleft lip– cleft palate compared with the
Farkas normative data set. (Above) Nasal tip protrusion, (center, left) alar base width, (center, right) alar width, (below,
left) columellar length, and (below, right) columellar width. The asterisk represents statistical significance between
the two groups using a one-sample t test (p ⬍ 0.05).
nasal reconstruction, there was no statistical difference at time points T2 and T3. At T4, the cleft
lip– cleft palate patients’ columella length was significantly shorter than the Farkas control group.
However, by T5 this difference had disappeared.
Columella Width (sn=-sn=)
Because surgical repair of the cleft lip can
narrow the columella and because of the technical
difficulty associated with accurately measuring
1664
the columella width on the models, the columella width was not measured at T1 and T2. At
T3 and T4, the cleft lip– cleft palate patients’
columella width was significantly wider than the
Farkas control group. However, by T5, this difference had disappeared.
DISCUSSION
The goal of nasoalveolar molding in the patient with bilateral cleft lip– cleft palate is to align
5.3 ⫾ 0.8
6.7 ⫾ 0.5
7.6 ⫾ 0.8
NAM, nasoalveolar molding.
Farkas
NAM
6.70 ⫾ 0.92
7.09 ⫾ 0.92
7.36 ⫾ 0.79
3.2 ⫾ 0.5
4.3 ⫾ 0.8
5.1 ⫾ 0.8
8.0 ⫾ 1.0
9.2 ⫾ 1.2
Farkas
NAM
0.42 ⫾ 0.62
4.47 ⫾ 0.91
5.40 ⫾ 1.17
6.50 ⫾ 0.95
8.43 ⫾ 2.09
25.0 ⫾ 1.3
26.0 ⫾ 1.5
26.2 ⫾ 1.5
28.7 ⫾ 1.8
31.5 ⫾ 2.1
Farkas
NAM
31.52 ⫾ 2.99
32.59 ⫾ 2.61
29.40 ⫾ 2.86
33.32 ⫾ 2.71
34.71 ⫾ 4.82
23.5 ⫾ 1.3
24.4 ⫾ 1.4
24.4 ⫾ 2.7
27.0 ⫾ 1.5
30.0 ⫾ 1.8
Farkas
NAM
30.80 ⫾ 3.10
32.03 ⫾ 2.40
26.84 ⫾ 2.88
29.66 ⫾ 2.02
30.17 ⫾ 2.78
Farkas
9.0 ⫾ 1.4
9.0 ⫾ 1.4
10.1 ⫾ 1.5
15.4 ⫾ 1.2
17.8 ⫾ 1.5
NAM
4.31 ⫾ 1.98
10.20 ⫾ 1.53
12.06 ⫾ 1.47
16.33 ⫾ 2.02
20.15 ⫾ 3.72
Age
37
34
18
16
9
T1
T2
T3
T4
T5
3.22 wk
5.56 mo
1.01 yr
7.04 yr
12.57 yr
No.
Time Point
Nasal Tip
Protrusion (mm)
Table 2. Nasal Morphology Results for Each Time Point
Alar Base
Width (mm)
Alar Width
(mm)
Columellar
Length (mm)
Columellar
Width (mm)
Volume 127, Number 4 • Analysis of Nasoalveolar Molding Outcome
the alveolar segments, place the lower lateral nasal
cartilages in their normal position, increase nasal
tip projection and convexity, stretch nasal lining
for a tension-free dome approximation, and increase columella length. Once this is achieved, the
primary lip and nasal reconstruction can be performed simultaneously. This potentially eliminates the need for an additional, separate nasal
reconstruction at an older age.
It is important to note that nasoalveolar molding alone is inadequate to produce the results
reported in this article. Nasoalveolar molding cannot remove fibrofat from between the domes of
the lower lateral cartilages, nor can it suture these
domes together such that scar tissue can cause
them to adhere together in a normal anatomical
relationship. If the nasoalveolar molding before
treatment produced adequate columella length
and tip shape, a simple Cutting retrograde nasal
dissection was performed. This method does not
require any nasal tip incisions. If the columella
length was inadequate following nasoalveolar
molding, a more aggressive Mulliken approach
using nostril apex incisions was used. In both surgical techniques, the domes of the lower lateral
cartilages were sutured together using polydioxanone suture. It was not possible to compare nasoalveolar molding with the Mulliken technique
alone, as too few of the latter procedures have
been performed at our institution.
One of the difficulties in evaluating anthropometric measurements of the nose in bilateral
cleft lip– cleft palate patients is deciding what
group should be selected as a control group for
the comparisons. Control group options include
noncleft controls and other bilateral cleft patients
who were treated with a different presurgical and
surgical technique. We selected the Farkas group
as our controls because we believe that the goal of
intervention in cleft lip– cleft palate patients
should be to achieve normal (noncleft) anatomy.
The Farkas data set includes measurements from
thousands of noncleft children at multiple ages
and is accepted as a reference guide for normative
anthropometric values. As described previously,
the differences between our patient population
and the population studied by Farkas are minor,
and we believe that valid conclusions can be drawn
from these comparisons.12 Furthermore, we believe that comparing our nasoalveolar molding
group to another bilateral cleft lip– cleft palate population would not be a fair comparison, as most of
the children receiving other treatment protocols
have had additional nasal reconstruction by the time
they are 12 years old. None of the patients in this
1665
Plastic and Reconstructive Surgery • April 2011
study underwent additional nasal reconstructive surgery after the initial primary reconstruction performed at the time of their lip repair.
When evaluating the specific anthropometric
measurements studied, several interesting observations can be made. Based on our analysis, we
would hope for a nonsignificant result between
the two groups, as this would imply that the treatment group was similar to the Farkas control
group in nasal morphology. Nasal tip protrusion
achieved following nasoalveolar molding and primary nasal reconstruction exceeded controls at
the time of cleft lip repair (T1) and cleft palate
repair (T2) (p ⬍ 0.05) but, although still longer
than the Farkas controls, had lost statistical significance at ages 7 and 12.5 years. This suggests an
equivalent nasal tip protrusion in the treatment
group relative to the Farkas control group, and the
two groups appear to be on parallel growth curves.
In the Farkas control group, nasal tip protrusion
is 89 percent complete by age 12. The alar base
width was initially excessive in the cleft group but
reached normal width by age 12.5 years (p ⬎ 0.05).
In the noncleft Farkas control group, alar base width
development is 91 percent complete by age 12.
The alar width was increased relative to the
noncleft group through the age of 7 years but
reached normal width by age 12.5 years (p ⬎ 0.05).
In addition, the magnitude of discrepancy appears
to remain relatively constant through T5. This is
important, as the alar base width and the alar
width can initially be set by the surgeon at the time
of the primary lip and nasal reconstruction. Because the growth of the nose appears to be proportional from the time of primary nasal reconstruction, these data imply that we might need to
further decrease the alar base width and alar width
at the time of our primary reconstruction.
Normal columella length was achieved with
nasoalveolar molding and primary nasal surgery,
and its length increased through age 12.5 years
(p ⬍ 0.05). Although there was a statistical difference between the two groups at time point T4, this
difference was gone by T5. In the noncleft Farkas
control group, columella length development is
78 percent complete by age 12. Again, the increase
in columella length between the study and control
groups appears to be on parallel growth curves.
Finally, the columella width was initially excessive
but normalized with growth over time, such that by
age 12.5 years there was no statistical difference
between the two groups. Based on the Farkas data,
nearly 80 percent of nasal growth is completed by
the age of 12 years. Because our treatment group
appears to be on a parallel growth curve with the
1666
noncleft Farkas controls, one might be tempted to
extrapolate that the nasal morphology and proportions of these patients with clefts will remain on
the same growth curve until nasal growth is complete. Although we believe this prediction is probable, only additional long-term follow-up will fully
answer this question.
One must also ask how this compares with
other presurgical infant orthopedic techniques.
In 1995, Mulliken, who has published extensively
on bilateral cleft lip repair,21–28 outlined the retrospective anthropomorphic analysis of his
repair.23 He divided his patients into three groups.
For purposes of analysis, only the last group is
comparable to our nasoalveolar molding study
population. In this group of patients, he used a
Georgiade-Latham pin-retained palatal appliance
before the primary surgery. In Mulliken’s article,
he only had measurements on four patients in this
group aged 1, 2, 4, and 5 years, and no exact
numbers are provided on the anthromorphic
analysis; this makes performing accurate comparisons difficult. He states that the nasal tip protrusion and columellar length are within 1 SD of
normal. In contrast, globally, there is little to no
statistical difference between the noncleft Farkas
patients and our patient population.
CONCLUSIONS
This is the first study to describe nasal morphology following nasoalveolar molding and primary nasal reconstruction in patients with bilateral cleft lip– cleft palate through the age of 12
years. In this investigation, we have shown that patients with bilateral cleft lip– cleft palate treated with
presurgical nasoalveolar molding required only
their initial primary nasal reconstruction, performed at the time of their lip repair, to attain nearly
normal nasal morphology through 12.5 years.
Barry H. Grayson, D.D.S.
Institute of Reconstructive Plastic Surgery
New York University Medical Center
560 First Avenue
New York, N.Y. 10016
[email protected]
PATIENT CONSENT
Parents or guardians provided written consent for
the use of patient images.
ACKNOWLEDGMENTS
All of the patients, treatments, surgeries and data collection for this study were performed at the Institute of
Reconstructive Plastic Surgery, New York University Medical Center.
Volume 127, Number 4 • Analysis of Nasoalveolar Molding Outcome
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