| CTRI Number |
CTRI/2025/04/084366 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Understanding Nasal Differences in Infants with Cleft Lip and Palate Using 3D Imaging |
|
Scientific Title of Study
|
Comparison of soft tissue nasal changes in unilateral cleft lip and palate with non-cleft lip and palate infants using 3-dimensional imaging |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Desai |
| Designation |
Post Graduate Student |
| Affiliation |
KAHERS KLE VK Institute of dental sciences |
| Address |
Department number 8, Orthodontics and Dentofacial Orthopedics, Second floor,
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC
campus, Nehru Nagar,
Belgaum
KARNATAKA
590010
India
JNMC Campus, Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
8806013131 |
| Fax |
|
| Email |
desaiabhishekn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Nilgar |
| Designation |
Professor |
| Affiliation |
KAHERS KLE VK Institute of dental sciences |
| Address |
Department number 8, Orthodontics and Dentofacial Orthopedics, Second floor,
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC
campus, Nehru Nagar,
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9886232242 |
| Fax |
|
| Email |
nilgaramit@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Nilgar |
| Designation |
Professor |
| Affiliation |
KAHERS KLE VK Institute of dental sciences |
| Address |
Department number 8, Orthodontics and Dentofacial Orthopedics, Second floor,
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC
campus, Nehru Nagar,
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9886232242 |
| Fax |
|
| Email |
nilgaramit@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopedics, KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belgaum, Karnataka, India, PIN: 590010 |
|
|
Primary Sponsor
|
| Name |
Abhishek Desai |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belgaum, Karnataka, India, PIN: 590010 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhishek Desai |
KLE VK INSTITUTE OF DENTAL SCIENCES |
Department of Orthodontics and dentofacial orthopedics, Department number 8, Second floor, KLE VK institute of dental sciences, Belagavi KARNATAKA 590010 India
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
8806013131
desaiabhishekn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Primary Cheilorhinoplasty |
Primary surgical lip and nose repair of the cleft lip region will be done in KLE Prabhakar Kore Hospital at 6 months of age of the intervention group, following which 3D photograph will be taken 1-2 days after the surgery |
| Comparator Agent |
Regular follow up |
Regular follow up of the comparator group, that is non cleft lip and palate infants will be done at 6 months of age, following which 3D photo will be taken |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
1. Infants with Unilateral cleft lip and palate presenting for the first time to the department of Orthodontics and Dentofacial Orthopedics at KLE VK Institute of Dental Sciences, Belagavi
2. Infants with birth weight less than 2kg
3. Infants whose parents give written informed consent |
|
| ExclusionCriteria |
| Details |
1. Infants with Bilateral Cleft lip and palate
2. Infants over the age of 4 weeks when they first report to the department of Orthodontics
3. Infants with systemic diseases or syndromes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in nasal shape following Primary Cheilorhinoplasty |
Baseline, at 6 months of age 1-2 days before surgery and 1-2 days after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in nasal symmetry following Primary Cheilorhinoplasty |
Baseline, at 6 months of age 1-2 days before surgery and 1-2 days after surgery |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cleft lip and palate
(CLP) is one of the most common congenital birth defects of the craniofacial
region. Unilateral cleft lip
and palate infants (UCLP) have a distinct phenotype resulting in various
degrees of nasolabial asymmetry due to structural deformity from nasolabial
anomaly, asymmetrical vermillion border, deviation of nasal septum and a deficient
maxilla. Judgement
of nasolabial aesthetics in cleft lip and palate (CLP) is a vital component of
assessment of treatment outcome. Nasoalveolar Moulding is one of the techniques used as a part of Pre surgical Infant Orthopedics, but it is not considered gold standard yet. In infants with cleft lip and palate, the primary lip closure surgery takes place around 3-6 months of age. The purpose of this study is to assess the shape and symmetry of the nose using 3D camera before and after the primary lip surgery in infants who have not undergone any treatment for the cleft lip and palate before the surgery. By evaluating the effectiveness of this approach, this study aims to contribute insights that could inform future strategies, ultimately formulating a treatment plan for patients with Cleft lip and palate right from the birth of these infants till adulthood. |