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CTRI Number  CTRI/2025/03/083640 [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   A Study on the Changes in Patients with Developing Class III Bite Problems Who Were Treated Using a Modified Splint, Class III Elastics, and a Chin Cup Appliance. 
Scientific Title of Study   Cephalometric and Psychometric evaluation of changes in patients with developing Class III malocclusion treated with the modified Splint Class III Elastics and Chin cup appliance modified sec III 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  Mohasin M 
Designation  PG student 
Affiliation  Mes Dental College 
Address  Department of orthodontics Room no 7 MES Dental College Palachode post Malappuram kerala
Palachode post Malappuram kerala
Malappuram
KERALA
679338
India 
Phone  08593841843  
Fax    
Email  m.mohasinvgd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vincy Antony 
Designation  Professor and HOD 
Affiliation  Mes dental college 
Address  MES Dental College Department of Orthodontics Malaparamba

Malappuram
KERALA
679338
India 
Phone  9846353153  
Fax    
Email  vincyantony2008@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vincy Antony 
Designation  Professor and HOD 
Affiliation  Mes dental college 
Address  MES Dental College Department of Orthodontics Malaparamba

Malappuram
KERALA
679338
India 
Phone  9846353153  
Fax    
Email  vincyantony2008@yahoo.com  
 
Source of Monetary or Material Support  
MES Dental College and Hospital Department of orthodontics Room no 7 MES Dental College Palachode post Malappuram 
 
Primary Sponsor  
Name  MES Dental College and Hospital 
Address  Department of orthodontics Room no 7 MES Dental College Palachode post Malappuram 
Type of Sponsor  Other [Private Dental College] 
 
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 Mohasin M  MES Dental College and Hospital  MES Dental College and Hospital Palachode PO Kolathur Via Perinthalmanna Malappuram Kerala
Malappuram
KERALA 
08593841843

m.mohasinvgd@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  Patients with developing skeletal Class III malocclusion having bilateral jaw discrepancy
or combination of maxillary retrognathism and mandibular prognathism will be included in
the study
Patients in the age group 10 to 14years
Angles Class III malocclusion with Anterior and posterior Crossbite
Wit’s appraisal of -2.0 mm or less and ANB less than 0 degrees
Skeletal maturation CVMI 2 and 3 stage
Absence of CO-CR discrepancy (indicating pseudo-Class III malocclusion)
Patients should be having healthy gingival and periodontal status  
 
ExclusionCriteria 
Details  Craniofacial malformations and syndromes Previous orthopedic or orthodontic treatments
History of facial trauma
Periodontitis
History of prolonged treatment with systemic steroids and NSAIDs Systemic diseases
including Diabetes mellitus or History of metabolic disorders
Presence of cysts tumors and other pathologies
Patients with disorders affecting bone healing metabolism and turn over 
 
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 psychological effects using PIDAQ and skeletal dental, soft tissue changes using cephalometric in patients with developing class III malocclusion undergoing modified SEC III protocol at two-time intervals: pre-treatment and post treatment  Before treatment begins typically within a few days or weeks before the intervention starts
post treatment after completion of active treatment once the SEC III appliance have concluded  
 
Secondary Outcome  
Outcome  TimePoints 
Duration taken for the correction of class III malocclusion by modified SEC III appliance  Before treatment begins typically within a few days or weeks before the intervention starts
post treatment after completion of active treatment once the SEC III appliance 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) -  proposal should be directed to m.mohasinvgd@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 THE MODIFIED SPLINT, CLASS III ELASTICS AND CHIN CUP APPLIANCE (MODIFIED SEC III )- AN OBSERVATIONAL STUDY

 INTRODUCTION

Intraoral and extraoral appliances are two of the therapeutic options that have been established to treat Class III dentoskeletal disharmony at an early stage. In skeletal class III malocclusion with maxillary retrusion, rapid maxillary expansion combined with the face mask (RME/FM) is recognized as the cornerstone of early orthopedic interception. The Splint, Elastic, Chin cup (SEC III) appliance—which combines two occlusal acrylic splints with Class III elastics and a chin cup—was first introduced in the 1980s. Both SEC III and RME/FM protocols are efficient treatment modalities for Class III dentoskeletal disharmony. The SEC III protocol produces more favorable control in intermaxillary vertical relationships than the RME/FM therapy. The modified SEC III protocol with RME, splints, Class III elastics with a chin cup will improve the treatment efficacy of developing Class III malocclusion. It allows greater intrusion of posterior teeth and helps in the anti-clockwise mandibular rotation and correction of overbite. It is useful in patients with vertical growth pattern.

Understanding the impact of malocclusion on quality of life requires an awareness of one’s oral health perception. The effects of malocclusion on a patient’s function, appearance, social relationships and mental health have been documented. Anatomical variations cause malocclusion; orthodontic  treatment attempts to correct these deviations from a prescribed norm. It has been demonstrated to have effects on the patient’s oral health-related quality of life (OHRQoL), in addition to psychological and physical effects. Normative measures are typically used to evaluate the correction of malocclusion, neglecting any potential psychological advantages.  This research makes use of Psychosocial impact of dental aesthetic questionnaire (PIDAQ) questionnaire to assess quality of life in patients treated with the modified SEC III appliance. It was recently verified and translated into Malayalam, and it was used in this study. Social, psychological, and aesthetic concerns are the three aspects of psychosocial impact that are measured by the PIDAQ.

RATIONALE AND RELEVANCE

This research compares changes in quality of life by PIDAQ from a patient’s perspective with cephalometric evaluation in the orthodontist’s perspective in patients treated with modified SEC III appliance. To the best of my knowledge, there is a gap in the literature regarding comparison of the psychological changes along with cephalometric changes in patients treated with modified SEC III appliance in the Kerala population.

RESEARCH QUESTION

How does treatment with modified SEC III appliance 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 30/5/2024 to 31/12/2025?

AIM

The aim of the study is to evaluate how treatment with the modified SEC III appliance 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

1.     Patients with developing skeletal Class III malocclusion having bilateral jaw discrepancy (combination of maxillary retrognathism and mandibular prognathism) will be included in the study.

2.     Patients in the age group 10-14years

3.     Angle’s Class III malocclusion with Anterior and posterior Crossbite

4.     Wit’s appraisal of -2.0 mm or less and ANB < 0 degrees

5.     Skeletal maturation CVMI 2&3 stage

6.     Absence of CO-CR discrepancy (indicating pseudo-Class III malocclusion)

7.     Patients should be having healthy gingival and periodontal status

EXCLUSION CRITERIA

1.     Craniofacial malformations and/or syndromes

2.     Previous orthopedic/orthodontic treatments.

3.     History of facial trauma

4.     Periodontitis

5.     History of prolonged treatment with systemic steroids and NSAIDs, Systemic diseases including Diabetes mellitus or History of metabolic disorders

6.     Presence of cysts, tumors, and other pathologies

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

 
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