PROPOSAL FOR GRANT FROM ICMR
Candidate Name
Dr. Shahista Parveen
Ph D Scholar
124/ JAN 2014
Guide
Dr. Akhter Husain
Professor and Head
Department of Orthodontics
Yenepoya University
Mangalore
Principal Investigator :
Co- Investigator :
Dr. Shahista Parveen
Ph D Scholar
Yenepoya University
Mangalore
[email protected]
Dr. Akhter Husain
Professor and Head
Department of Orthodontics
Yenepoya University
Mangalore
[email protected]
RESEARCH TITLE
Influence of Orthodontics treatment modalities on
craniofacial structures in nonsyndromic unilateral cleft lip
and palate – A Cone Beam Computed Tomographic Study
OBJECTIVES
 To assess various craniofacial structures in nonsyndromic
complete unilateral Cleft Lip and palate patients in
unoperated adult cases using CBCT
 To assess the skeletal and soft tissue changes in nonsyndromic
complete unilateral Cleft lip and palate patients following
Lefort I surgery using CBCT
 To assess the skeletal and soft tissue changes in nonsyndromic
complete unilateral Cleft lip and palate following Anterior
Maxillary Distraction using CBCT
OBJECTIVES
 To assess the skeletal and soft tissue changes in nonsyndromic
complete unilateral Cleft lip and palate following Rapid maxillary
expansion using CBCT.
 To compare the skeletal and soft tissue changes in nonsyndromic
complete unilateral Cleft lip and palate following two different
protocols.
LITERATURE REVIEW
 CLP – commonest craniofacial Disorder
 Incidence- ranging from 1 in 300 to 1 in 2,500 live births
 The incidence of cleft lip and palate in India is about 1in 1000
 CBCT - a new diagnostic tool provides excellent imaging
 CBCT examination significantly increased the confidence of
orthodontists in their diagnostic and treatment plans
LITERATURE REVIEW
CBCT IN ORTHODONTICS
 Airway analysis
 Assessment of alveolar bone heights and bone volume
 Assesment of root resorption
 Detection of implant site
 Generation of dental models and
 Detection of cephalometric land marks
The guidelines recommended by American
Association of Orthodontists-application of CBCT
 In specific cases where conventional radiography fail to supply
satisfactory diagnostic information
 Since cleft lip and palate is the most common craniofacial
anomaly,
CBCT imaging can be used to enhance the
diagnostic knowledge
CBCT IN CLEFT LIP PALATE PATIENTS
 To assess the thickness and level of alveolar bone around the teeth
adjacent to the cleft
 To quantify the treatment outcome of secondary alveolar bone grafting
 To study craniofacial, maxillary and mandibular changes resulting
from rapid maxillary expansion
 For the evaluation of the upper, lower and total airway volumes
 Evaluation of the Alar Base thickness in Unilateral Secondary Lip
Nasal Deformities
 Alveolar bone morphology
 Influence of intervention on hard and soft tissues of the structures
AMOUNT OF GRANT-IN-AID ASKED FOR
Budget Amount
Total
3,11,000
Year 1
Year 2
Year 3
Rs 145000
Rs 146000
Rs 20000
Institutional ethical clearance and Project approval -To be taken
Is radio tagged material proposed to be used in the project either for
clinical trials or experimental purposes? If so, clearance from Nuclear
Medicine Committee, Bhabha Atomic Research Centre, Mumbai,
indicating should be attached- To be taken
Projects involving recombinant DNA/Genetic engineering work should
be examined and certificate by the Institutional Biosafety Committee
(IBSC) to be enclosed. NA
Approval of the institutional ethics committee(IEC) should be
enclosed. Guidelines for IEC for animal experiments should follow
CPCSEA requirements and for human studies should follow ICMR
guidelines. To be taken from Institutional Ethical Committee
The Institution where the study is being done should ensure that there
is no financial conflict of interest by the investigators. To be attached
DURATION OF RESEARCH PROJECT
1. Period which may be needed for collecting the data : 24 months
11.Period that may be required for analyzing the data : 6months
III. Dissemination of results and communication of findings: 12
months
DETAILS OF THE RESEARCH PROJECT
STUDY DESIGN
Sample size
12 unoperated cleft Lip and palate
15- undergoing Le fort I
15- undergoing Anterior maxillary distraction
15- undergoing RME appliance to treat transverse discrepancy
20- control group
(Note: furthermore catogorization based on involvement of side, age
and gender need to be done based on the availibilty of sample)
STUDY SUBJECTS
1. Experimental subjects- nonsyndromic complete UCLP- no history
previous treatment for their clefts.
2. Experimental subjects - nonsyndromic complete UCLP – history of
primary repair of cleft lip and palate. They are undergoing Le Fort I
Orthognathic Surgery to address hypoplastic maxilla.
3. Experimental Subjects- nonsyndromic complete UCLP with history
of primary repair of cleft lip and palate. They are undergoing
Anterior Maxillary Distraction to treat hypoplastic maxilla.
STUDY SUBJECTS
4. Experimental Subjects - nonsyndromic complete UCLP - history
of primary repair of cleft lip and palate. They are undergoing
Rapid Maxillary Expansion to treat transverse discrepancy of
maxilla
5. Control group who will be taking CBCT as a part of orthodontic
diagnostic record. (TMJ assessment, location of impaction,
pharyngeal airway analysis)
Incusion Criteria
Nonsyndromic unilateral cleft lip and palate
 Adult patients -no history of primary surgery for repair of
cleft lip and palate
 Adult patients - history of primary surgery for repair of
cleft lip and palate need to address sagittal descrepancy
 Adult patients -no history of primary surgery for repair of
cleft lip and palate need to address transverse problem
Exclusion Criteria
 unilateral Cleft lip and palate associated with syndromes
 Bilateral Cleft lip and palate
 Cleft patients who were treated for side involvement.
INSTITUTION RESPONSIBLE FOR THE RESEARCH
PROJECT
Yenepoya University
University Road,
Deralakatte,
Mangalore 575018.
Phone: +91 824 2204668/69/70
Fax: +91 824 2204667
email:[email protected]
CBCT SETTINGS- STANDARDIZATION
• All images for Orthodontic diagnostic records will be taken in a
standard Position using the same machine -Planmeca ProMax 3D
• Scanning times will be fixed at 14 to 18 seconds
•
Collimation height will be fixed at 13 cm
•
Exposure time will be fixed
•
Voxel size will be kept at 0.3 mm³.
• The patients will be asked to bite with maximum interdigitation
and not to move their heads or tongues during scanning.
• The 3D images will be transformed to Planmeca Romexis
software and read by Planmeca Romexis® Viewer
 Purpose of the study will be informed to the patients who will be
reporting to the Department of Craniofacial surgery
 Informed consent will be taken from the patients that their
CBCT records will be taken for the study.
 Ethical clearance will be taken before the study from IEB of our
University.
 CBCT will be taken before the treatment as a part of diagnostic
record and after the treatment to assess and compare soft tissue
and hard tissue changes associated with different treatment
modalities.
 Cranio facial measurement of pre and post treatment CBCT
images will be taken.
 For standardization, measurements of all the images will be taken
by the same observer.
 Measurement will be repeated by the same observer, randomly
selecting few of the images without knowing the preious
measurement
STATISTICAL ANALYSIS
Data will be checked for normality
Test statistics - Kolmogorov-Smirnov test, Shapiro Wilks
Anova if data follows normaliy
between thegroups
Kruskal Wallis if data does not follow normality
Post hoc test- within the group
Pre and post intervention comprison- Paired t test
Association between two groups
Unpaired t test- if data follows normality
Mann Whitney tast- if data does not follow normality
SUMMARY OF THE PROPOSED WORK
 Cleft lip and palate, one of the most common facial malformation
in mankind.
 The management of cleft lip and palate presents a great challenge
 Many children still receive care that is substantially inferior
 Failure in diagnosing the problems
 Cleft child problem quite different from the routine orthodontic
patient
 Superimposition of structures and magnifying errors occurred by
conventional 2- dimensional radiographs
 CBCT- a new 3D diagnostic tool
 To determine craniofacial characteristics of cleft patients and
compare with the normal.
 To achieve good esthetic and function
Practitioners should be aware that 3D data present new challenges
and a different approach from traditional viewing of static images.
The study needs evaluation of changes taking place following
various Orthodontic treatment modalities
Anterior Maxillary Distraction
Le Fort Orthognathc Surgery
RME expansion
Time taken for the project
Collection of data = 2years
Analysis of data = 6months
Presentation of result and drafting = 8months
The study needs minimum of about 4 years to complete.
Budget items
Personal
Research
participant
Year 1
Year 2
Year 3
Travel
20,000
20,000
-------
Support
Assistant
50,000
50,000
Travel expenses
20,000
20,000
Incentives for the
research participants
30,000
30,000
1000
1000
------
10,000
--------
-------
25,000
25,000
---------
Communication
expenses
Telephone expenses
Materials Charges Pilot study
(Consumable)
Proper Study
Consumable
Miscellaneous
Printing charges
Graphic assistance
Statistical tests
-----------
10,000
5,000
5,000
Justification
Travel to different places in search of
target subjects.
Assistance is required for data
collection, arrangement of collected
data
Participants will be travelling from
different places.
Rewards for subjects who consented
to be a part of research.
Communicating with patients on
telephone
To check the feasibility of the study,
pilot study is necessary.
1CBCT scan costs 10,000
10 subjects X 1,000= 1000
25 subjects X 2,000= 50,000
Pre and post intervention CBCT
Expenses towards thesis writing and
submission
Payment to graphic assistant
Payment to statistician
SCOPE OF THIS STUDY
Cleft lip and palate, one of the commonest craniofacial disorders
affecting one in every 1000 population in India.
The main aim of this research is to determine craniofacial
characteristics of cleft patients and compare with the normal so as to
establish new craniofacial analysis for proper diagnosis.
 By establishing proper diagnosis, craniofacial team will be able to
treat them to achieve esthetic and function.
A proper treatment will improve the social well being of a cleft child.
Please describe how the team of investigators incorporates the
range of discipline and experience necessary to carry out the
study.
Maxillofacial Surgeon: Dr. Mustafa who has ample experience
hypoplastic maxilla by Anterior Maxillary Distraction will be
guiding in that field
Maxillofacial Surgeon: Dr. Srinivas Gosla Reddy who has ample
experience in treating hypoplastic maxilla by lefortI and
modification will be guiding in that field
Maxillofacial Radiologist: Dr. Junaid will be guiding reading CBCT
images
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THANK YOU