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CTRI Number  CTRI/2025/03/083589 [Registered on: 27/03/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A questionnaire Study for Assessing How Orthodontic treatment and Surgery Affects the Quality of Life of Patients in Malappuram district with Specific Jaw Misalignments 
Scientific Title of Study   Short term assessment of quality of life of patients with skeletal Class II and Class III malocclusion undergoing combined surgical and orthodontic treatment A prospective 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  Aswathy Chandran 
Designation  Post Graduate Student 
Affiliation  MES Dental College Kerala 
Address  MES Dental College and Hospital First floor Room no 7 Department of orthodontics PO Kolathur Perinthalmanna Malappuram Kerala

Malappuram
KERALA
679338
India 
Phone  9497025828  
Fax    
Email  chandranaswathy828@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vincy Antony 
Designation  Professor and HOD 
Affiliation  MES Dental College  
Address  MES Dental College and Hospital First floor Room no 7 Department of orthodontics PO Kolathur Perinthalmanna Malappuram Kerala

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 and Hospital, First floor Room no 7 Department of orthodontics PO Kolathur Perinthalmanna Malappuram Kerala

Malappuram
KERALA
679338
India 
Phone  9846353153  
Fax    
Email  vincyantony2008@yahoo.com  
 
Source of Monetary or Material Support  
MES Dental College and Hospital, First floor Room no 7 Department of orthodontics PO Kolathur Perinthalmanna Malappuram Kerala 
 
Primary Sponsor  
Name  MES Dental College 
Address  MES Dental College and Hospital First floor Room no 7 Department of orthodontics PO Kolathur Perinthalmanna Malappuram Kerala 
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 Aswathy Chandran  MES Dental College, Perinthalmanna  Department of Orthodontics,Room No 7,First floor,Malappuram KERALA Malappuram KERALA
Malappuram
KERALA 		 9497025828

chandranaswathy828@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE , MES DENTAL COLLEGE PERINTHALMANNA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Patients with skeletal Class II and III malocclusion who will be selected for combined surgical-orthodontic treatment (regardless of the severity of the skeletal malocclusion) in MES Dental college Perinthalmanna having an IOTN dental health component of Grade 3 and above
Patients in the age group between 18 and 30
Willingness to participate in the study.
 
 
ExclusionCriteria 
Details  Patients with congenital abnormalities such as craniofacial syndrome or cleft lip/palate
Patients with jaw deformity as a sequel to maxillofacial trauma
Presence of chronic diseases
Daily use of anti-depressive medication
Presence of advanced periodontal disease
Surgeries performed from other institutions
Patient with disorders affecting bone healing, metabolism and turn over
Those whose legal representatives do not authorize participation in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome will be the assessment of improvement in PIDAQ scores at various stages of treatment  T0 Pre-Surgery (1 month prior to Surgery)
T1 1 month after surgery
T2 3 months After surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome will be association these scores with age, gender and marital status  pre-surgery (T0), 1 to 2 weeks after orthognathic surgery (T1), and 3 months after orthognathic surgery (T2). 
 
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   N/A 
Date of First Enrollment (India)   08/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="10"
Days="4" 
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 - 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 chandranaswathy828@gmail.com

  6. For how long will this data be available start date provided 08-04-2025 and end date provided 08-04-2026?
    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  

Short term assessment of quality of life of patients with skeletal Class II and Class III malocclusion undergoing combined surgical and orthodontic treatment – A prospective study.

 2.  RATIONALE AND RELEVANCE

 

Quality of Life (QoL) is defined as an individual’s perception of the position in life in the context of cultural and value systems in which they live and in relation to their personal goals, expectations, standards and concerns (WHOQOL).1 Aesthetics plays a very important role in a patient’s decision for orthodontic treatment, even in cases of clear medical necessity. The motivation for improvement of aesthetics is mainly psychosocial in origin. Physical attractiveness is naturally a major contributor to self-esteem and thus affects one’s overall sense of well-being.


RESEARCH QUESTION

 

Are there any changes in the psychological status of patients with skeletal Class II and Class III malocclusion undergoing combined surgical and orthodontic treatment before and after orthognathic surgery in Malappuram population?


AIM AND OBJECTIVES

 

The aim of the study is to evaluate the psychological changes occurring at different clinical time-points in patients undergoing combined surgical-orthodontic treatment.

 7 INCLUSION CRITERIA

 

1.      Patients with skeletal Class II and III malocclusion who will be selected for combined surgical-orthodontic treatment (regardless of the severity of the skeletal malocclusion) in MES Dental college Perinthalmanna having an IOTN dental health component of Grade 3 and above

2.      Patients in the age group between 18 and 30

3.      Willingness to participate in the study.

 

9.8 EXCLUSION CRITERIA 

 

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

2.     Patients with jaw deformity as a sequel to maxillofacial trauma 

3.     Presence of chronic diseases

4.     Daily use of anti-depressive medication

5.     Presence of advanced periodontal disease

6.     Surgeries performed from other institutions

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

Those whose legal representatives do not authorize participation in the study



 
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