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CTRI Number  CTRI/2025/03/083755 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 28/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Impact of Jaw expansion and an External pulling device on facial growth and well being in People with jaw misalignment 
Scientific Title of Study   Cephalometric and psychometric evaluation of changes in patients with developing Class III malocclusion treated with Rapid maxillary expansion and Reverse pull headgear-An observational study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashida Sherin Olappilan 
Designation  PG student 
Affiliation  MES Dental college and Hospital 
Address  Dream valley MES mampad college p o PIN 676542
Department of Orthodontics MES Dental college and Hospital Palachode P O Kolathur Via Perinthalmanna PIN 679338
Malappuram
KERALA
676542
India 
Phone  9048192461  
Fax    
Email  ashidasherin@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr VINCY ANTONY MARGARET 
Designation  Professor and HOD  
Affiliation  MES Dental College and Hospital 
Address  Department of Orthodontics MES Dental college and Hospital Palachode P O Kolathur Via Perinthalmanna

Malappuram
KERALA
679338
India 
Phone  9846353153  
Fax    
Email  vincyantony2008@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr VINCY ANTONY MARGARET 
Designation  Professor and HOD  
Affiliation  MES Dental College and Hospital 
Address  Department of Orthodontics MES Dental college and Hospital Palachode P O Kolathur Via Perinthalmanna

Malappuram
KERALA
679338
India 
Phone  9846353153  
Fax    
Email  vincyantony2008@yahoo.com  
 
Source of Monetary or Material Support  
MES Dental College and Hospital Palachode P O Kolathur Via Perinthalmanna PIN 679338  
 
Primary Sponsor  
Name  MES Dental College and Hospital 
Address  MES Dental college and Hospital Palachode P O Kolathur Via Perinthalmanna PIN 679338  
Type of Sponsor  Other [Private Dental College and Hospital] 
 
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 
Ashida Sherin Olappilan  MES Dental College and Hospital  Department of Orthodontics Room no 7
Malappuram
KERALA 
09048192461

ashidasherin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE MES Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1 Patients with developing skeletal Class III and Angles Class III malocclusion with maxillary deficiency and anterior and posterior crossbite indicated for RMEand FM treatment in MES Dental CollegePerinthalmanna
2 Patients in the age group between 10 to 14 years
3 Patients should be having healthy gingival and periodontal status
4 Wits appraisal of -2mm or less and ANB less than 0 degree
5 Absence of CO CR discrepancy
 
 
ExclusionCriteria 
Details  1 Patients with congenital abnormalities such as craniofacial syndrome or cleft lip and palate
2 Presence of systemic diseases
3 Daily use of anti depressive medication
4 Presence of periodontal disease
5 Patients with disorders affecting bone healing metabolism and turn over
6 Those whose legal representatives do not authorize participation in the study
7 History of facial trauma
8 Previous orthodontic treatment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the cephalometric changes and psychological status using cephalometric analyses and PIDAQ questionnaire in patients with developing Class III malocclusion treated with RME and FM   Before treatment begins typically within a few days or weeks before the intervention starts
Post treatment After completion of active treatment once the RME and Reverse Pull Headgear treatment have concluded 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of gender on pre and posttreatment psychometric changes evaluated using PIDAQ  Before treatment begins typically within a few days or weeks before the intervention starts
Post treatment After completion of active treatment once the RME and Reverse Pull Headgear treatment have concluded 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   10/04/2025 
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="1"
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 - 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 - Informed Consent Form
    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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to ashidasherin@gmail.com

  6. For how long will this data be available start date provided 10-04-2025 and end date provided 10-10-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Cephalometric and psychometric evaluation of changes in patients with developing Class III malocclusion treated with rapid maxillary expansion and reverse pull headgear-An Observational study

2.INTRODUCTION, RATIONALE, RELEVANCE

Class III malocclusion patients have distinct dentofacial growth discrepancies that manifest early in life. These include retrognathic maxilla, prognathic mandible and dentoalveolar compensations, such as increased proclination of maxillary incisors and retroclination of mandibular incisors.The treatment of Class III malocclusion varies depending on the age and severity of malocclusion and include growth modification, dental camouflage and orthognathic surgery. Intraoral and extraoral orthopaedic and functional appliances are among the therapeutic options that have been developed to address Class III dentoskeletal disharmony in its early stages. In situations of maxillary retrusion in skeletal class III cases, the rapid maxillary expansion appliance combined with face mask (RME/FM) is recognised as the cornerstone of early orthopaedic interception. Patients in the early mixed dentition respond better to RME-FM treatment than those in later stages of dental development.

Anatomical variations cause malocclusion; orthodontic treatment attempts to correct these deviations from a prescribed norm. Normative measures are typically used to evaluate malocclusion and its orthodontic repair, neglecting any potential psychological advantages. With the development of psychometric instruments to quantify this intangible aspect of health, this idea has undergone a paradigm shift. This research makes use of PIDAQ questionnaire to assess quality of life in patients treated with RME/FM. PIDAQ was first created in German and has demonstrated strong cross-cultural psychometric qualities. It was recently verified and translated into Malayalam, and it will be used in this study.

To the best of my knowledge, very few research have looked at the cephalometric and psychological effects of patients treated with RME/FM . This study therefore aims to evaluate the cephalometric changes and psychological status in terms of their subjective sense of well-being, as measured by the four-factor scale of the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) in patients with developing Class III malocclusion treated with RME/FM who report to the Department of Orthodontics, MES Dental College, Perinthalmanna

RESEARCH QUESTION

How does treatment with RME/FM affect the normative outcome assessed using cephalometric analysis and patient-reported outcome assessed using PIDAQ in patients with developing Class III malocclusion at two clinical time points in the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College, Perinthalmanna from 25/5/2024 to 31/12/2025?

AIM

The aim of the study is to evaluate how treatment with RME/FM affect the normative outcome assessed using cephalometric analysis and patient-reported outcome assessed using PIDAQ in patients with developing Class III malocclusion at two clinical time points in the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College, Perinthalmanna.

  INCLUSION CRITERIA

      The inclusion criteria include

1.     Patients with developing skeletal Class III and Angle’s Class III malocclusion with maxillary deficiency and anterior and posterior crossbite indicated for RME/FM treatment in MES Dental College, Perinthalmanna.

2.     Patients in the age group between 10 to 14 years.

3.     Patients should be having healthy gingival and periodontal status.

4.     Wit’s appraisal of -2mm or less and ANB < 0 degree.

5.     Absence of CO-CR discrepancy.

  EXCLUSION CRITERIA

     The exclusion criteria are

1.     1.Patients with congenital abnormalities such as craniofacial syndrome or cleft lip/palate

2.     2.Presence of systemic diseases

3.     3.Daily use of anti-depressive medication

4.     4.Presence of  periodontal disease

5.     5.Patients with disorders affecting bone healing, metabolism and turn over

6.     6.Those whose legal representatives do not authorize participation in the study.

7.    7. History of facial trauma.

8.Previous orthodontic treatment 
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