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CTRI Number  CTRI/2025/05/087973 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 29/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of treatment outcomes with Rhinoplastic Appliance System with and without the use of intraoral plate in patients with Unilateral Cleft Lip and Palate 
Scientific Title of Study   Comparative Assessment of Rhinoplastic Appliance System with and without the Integration of Intraoral Appliance in Unilateral Cleft Lip and Palate  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Simran Shakya 
Designation  Post Graduate Student  
Affiliation  Manav Rachna Dental College 
Address  Manav Rachna Dental College School of Dental Science MRIIRS Department no 3 Ground floor Surajkund Road Faridabad Haryana 121003 India Faridabad HARYANA 121003 India

Faridabad
HARYANA
121003
India 
Phone  8370998139  
Fax    
Email  shakyasimran2018@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Puneet Batra 
Designation  Principal (Prof) HOD 
Affiliation  Manav Rachna Dental College 
Address  Manav Rachna Dental College School of Dental Science MRIIRS Department no 3 Ground floor Surajkund Road Faridabad Haryana 121003 India Faridabad HARYANA 121003 India

Faridabad
HARYANA
121003
India 
Phone  9810335961  
Fax    
Email  drpuneetbatra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dhruv Ahuja 
Designation  Senior lecturer 
Affiliation  Manav Rachna Dental College 
Address  Manav Rachna Dental College School of Dental Science MRIIRS Department no 3 Ground floor Surajkund Road Faridabad Haryana 121003 India Faridabad HARYANA 121003 India

Faridabad
HARYANA
121003
India 
Phone  8722122484  
Fax    
Email  dhruvahuja96@gmail.com  
 
Source of Monetary or Material Support  
Manav Rachna Dental College and hospital department of orthodontics and dentofacial orthopedics faridabad- 121003 
 
Primary Sponsor  
Name  Simran Shakya 
Address  Manav Rachna Dental College School of Dental Science MRIIRS Department no 3 Ground floor Surajkund Road Faridabad Haryana 121003 India Faridabad HARYANA 121003 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Simran Shakya  Manav Rachna Dental College  Manav Rachna Dental College School of dental Sciences MRIIRS Department no 3 Ground Floor Surajkund Road Faridabad Haryana Faridabad 121003 HARYANA
Faridabad
HARYANA 		 8370998139

shakyasimran2018@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manav Rachna Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q385||Congenital malformations of palate, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nasoalveolar moulding in Unilateral Cleft Lip and Palate   Nasoalveolar Moulding with Rhinoplastic Appliance System with intraoral plate 
Comparator Agent  Nasoalveolar moulding with Rhinoplastic Appliance System without intraoral plate  Nasoalveolar moulding in Unilateral Cleft Lip and Palate with Rhinoplastic Appliance System without intraoral plate 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  3.00 Month(s)
Gender  Both 
Details  Non Syndromic Unilateral Cleft Lip And Palate Born at full term
0 days – 3 months infants for PSIO
3-6 months infants for post surgery follow up
 
 
ExclusionCriteria 
Details  Syndromic cleft lip and palate
Infant with systemic diseases
Infants with Simonart’s Band
Parents/ guardians not providing assent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of intra group arch dimension and facial esthetics
comparison of inter group evaluation of arch dimension and facial esthetics
 		 T0 before Nasoalveolar moulding at baseline
T1 after Nasoalveolar moulding at 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of arch dimension and facial esthetics after primary lip surgery  T2 6 months after primary lip surgery 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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 4 
Date of First Enrollment (India)   11/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shakyasimran2018@gmail.com].

  6. For how long will this data be available start date provided 16-06-2025 and end date provided 01-06-2027?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   In this study, patients with Unilateral Cleft Lip and Palate will be assessed to evaluate the outcome changes in facial esthetics and arch dimensions using Rhinoplastic  Appliance system device for Presurgical Nasoalveolar Moulding with and without intraoral appliance and also assess the force vector of the appliance using Dynamic Finite Element Model.
To evaluate the effect of the appliance on nasal symmetry, 6 months post lip surgery follow up with the use of nasal appliance, RAS.
 
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