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CTRI Number  CTRI/2025/04/084490 [Registered on: 09/04/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Novel Approach For Maxillary Advancement 
Scientific Title of Study   COMPARISON OF SKELETAL DENTAL AND SOFT TISSUE CHANGES IN GROWING SKELETAL CLASS III INDIVIDUALS USING FACEMASK WITH RME VS CUSTOMISED MINI PLATES - A RANDOMISED CONTROLLED TRIAL  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nataleya Felix 
Designation  Post Graduate 
Affiliation  Saveetha Dental College and Hospitals 
Address  No.169, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai. Thiruvallur TAMIL NADU 600077 India

Chennai
TAMIL NADU
600077
India 
Phone  7904989610  
Fax    
Email  152308007.sdc@saveetha.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srirengalakshmi Muthuswamy Pandian 
Designation  Associate Professor 
Affiliation  Saveetha Dental College and Hospitals 
Address  No.169, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai. Thiruvallur TAMIL NADU 600077 India

Chennai
TAMIL NADU
600077
India 
Phone  8867783552  
Fax    
Email  rengalakshmi1910@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nataleya Felix 
Designation  Post Graduate 
Affiliation  Saveetha Dental College and Hospitals 
Address  No.169, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai. Thiruvallur TAMIL NADU 600077 India

Chennai
TAMIL NADU
600077
India 
Phone  7904989610  
Fax    
Email  152308007.sdc@saveetha.com  
 
Source of Monetary or Material Support  
Saveetha Dental College and Hospitals No 162, Poonamallee High Road Velappanchavadi Chennai 600077 
 
Primary Sponsor  
Name  L Felix Reginald 
Address  194/77 Addis Street, Grey Town, Uppilipalayam Coimbatore 641018 
Type of Sponsor  Other [Labour Officer] 
 
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 
Nataleya Felix  Saveetha Dental College and Hospitals  Clinic 27, Fifth floor, Department of Orthodontics
Chennai
TAMIL NADU 		 7904989610

152308007.sdc@saveetha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethical Committee (SDC-IHEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bonded RME with Facemask  Bonded RME with conventional facemask will be used 
Intervention  Maxi Pro Bone Plates  MaxiPro Bone plates are used in Skeletal Class III Growing patients with maxillary hypoplasia to protract the maxillary bone and to improve the facial appearance at an early age to avoid surgical treatment  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  13.00 Year(s)
Gender  Both 
Details  Skeletal Class III patients with maxillary hypoplasia
growing patients 
 
ExclusionCriteria 
Details  Growing children with Skeletal class II due to prognathic mandible
Adults with Skeletal class III malocclusion 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Skeletal, Dental, Soft tissue changes  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Airway changes  6 months 
 
Target Sample Size   Total Sample Size="7"
Sample Size from India="7" 
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   N/A 
Date of First Enrollment (India)   01/05/2025 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rengalakshmi1910@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   none 
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