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CTRI Number  CTRI/2025/03/082477 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   How Braces Affect Quality of Life in Patients with Different Types of Teeth Misalignment A Study Using a Special Questionnaire 
Scientific Title of Study   Assessment of quality of life using MRQoLQ (Malocclusion related quality of life questionnaire)during fixed orthodontic treatment in patients with different sagittal malocclusions-A prospective study. 
Trial Acronym  NOT APPLICABLE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhavya V 
Designation  Post Graduate Student 
Affiliation  MES DENTAL COLLEGE and HOSPITAL 
Address  MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 Palachode PO Kolathur via Perinthalmanna Malappuram
MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 Palachode PO Kolathur via Perinthalmanna Malappuram
Malappuram
KERALA
679338
India 
Phone  09048746405  
Fax    
Email  drbhavyavijay@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Muhammed Shaloob KM 
Designation  Professor  
Affiliation  MES DENTAL COLLEGE and HOSPITAL 
Address  MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 Palachode PO Kolathur via Perinthalmanna Malappuram
MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 Palachode PO Kolathur via Perinthalmanna Malappuram
Malappuram
KERALA
679338
India 
Phone  9746277277  
Fax    
Email  shaloobdr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhavya V 
Designation  Post Graduate Student 
Affiliation  MES DENTAL COLLEGE and HOSPITAL 
Address  MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 PO Palachode Kolathur via Perinthalmanna Malappuram Kerala Pin 679338
MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 PO Palachode Kolathur via Perinthalmanna Malappuram Kerala Pin 679338
Malappuram
KERALA
679338
India 
Phone  9048746405  
Fax    
Email  drbhavyavijay@gmail.com  
 
Source of Monetary or Material Support  
MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 PO Palachode Kolathur via Perinthalmanna Malappuram Kerala Pin 679338 
 
Primary Sponsor  
Name  MES DENTAL COLLEGE and HOSPITAL 
Address  MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 PO Palachode Kolathur via Perinthalmanna Malappuram Kerala Pin 679338 
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 Bhavya V  MES Dental College and Hospital  MES DENTAL COLLEGE and HOSPITAL Department Of Orthodontics Room no 7 PO Palachode Kolathur via Perinthalmanna Malappuram Kerala Pin 679338
Malappuram
KERALA 		 09048746405

drbhavyavijay@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  13.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Patients with Angles class I class II, class III Malocclusion with corresponding skeletal class I ClassII, ClassIII malocclusions. 
 
ExclusionCriteria 
Details  Patients who have undergone any prior orthodontic treatment.
presence of systemic disease affecting patients quality of life.
subjects with any craniofacial syndromes
cleft and palate patients
patients indicated for surgical treatment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare and evaluate psychosocial impact ,socioeconomic status, self confidence, and functional impact using MRQoLQ in patients with different sagittal malocclusions undergoing fixed orthodontic treatments  T0-pre treatment
T2-after 1month of treatment
T3-after leveling and alignment 
 
Secondary Outcome  
Outcome  TimePoints 
To determine which time points shows maximum changes in the oral health related quality of life of patients assessed using MRQoLQ during fixed orthodontic treatment  T0-pre treatment
T1-After 1 month of treatment
T2-After leveling and alignment



 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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)   28/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/03/2025 
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 drbhavyavijay@gmail.com

  6. For how long will this data be available start date provided 28-03-2025 and end date provided 28-03-2026?
    Response (Others) -  NIL

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

Assessment of quality of life using MRQoLQ (Malocclusion-related quality of life questionnaire) during fixed orthodontic treatment in patients with different sagittal malocclusions– A prospective study.

.RATIONALE AND RELEVANCE 

Currently, the demand for orthodontic treatment is largely based on patients’ own perception of dental aesthetics. However, the diagnosis entailing the need for orthodontic treatment has traditionally been based on mainly normative and objective evaluation using cephalometric measurements that treat the pathology from a professional perspective.3 So, this approach barely considers the patient’s perception of their own malocclusion and the challenges they face routinely both at functional as well as social level. To the best of my knowledge, there is no similar study in literature using MRQoLQ as a tool assessing the psychosocial impact of malocclusion. Therefore, the purpose of this study is to evaluate the association between different sagittal malocclusions and quality of life using MRQoLQ in patients reporting to the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College, Perinthalmanna.

RESEARCH QUESTION

Is there any association between the type of sagittal malocclusion and quality of life in patients aged 13 - 30 years assessed at three clinical time points using MRQoLQ during comprehensive orthodontic treatment in the Department of Orthodontics and Dentofacial Orthopaedics, MES Dental College, Perinthalmanna from June 2023 -January 2025? 

AIM

  • Aim of the study is to evaluate association between the type of sagittal malocclusion and quality of life in patients assessed using MRQoLQ during fixed orthodontic treatment.

PRIMARY OBJECTIVES

  • To compare and evaluate psychosocial impact, socioeconomic status, self-confidence and functional impact using MRQoLQ in patients with different sagittal malocclusions undergoing fixed orthodontic treatment.

 SECONDARY OBJECTIVES

  • To determine which time points shows maximum changes in the oral health related - quality of life of patients assessed using MRQoLQ during fixed orthodontic treatment.

  •  INCLUSION CRITERIA

  • Patients with Angle’s Class I, Class II, Class III malocclusion with corresponding skeletal Class I, Class II, Class III Malocclusions.

    • Patient aged 13 to 30yrs.

    EXCLUSION CRITERIA

    • Patients who have undergone any prior orthodontic treatment.

    • Presence of systemic diseases affecting patient’s quality of life.

    • Subjects with any craniofacial syndromes.

    • Cleft lip and palate patients.

    • Patients indicated for surgical treatment.



 
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