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CTRI Number  CTRI/2024/10/075151 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 27/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   Effect of fixed braces on the oral bacteria in adolescent and adult patients using next generation sequencing (a type of gene analysis of bacteria): A longitudinal comparative study. 
Scientific Title of Study   The impact of fixed orthodontic appliances on the oral microbiome in adolescent and adult patients using next generation sequencing (NGS) : A longitudinal comparative 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  GARIMA ARORA 
Designation  Senior Lecturer 
Affiliation  Manav Rachna Dental College 
Address  Department of Orthodontics & Dentofacial Orthopedics, Manav Rachna Dental College, Faridabad

Faridabad
HARYANA
121004
India 
Phone  09802664902  
Fax    
Email  garimaarora483@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  GARIMA ARORA 
Designation  Senior Lecturer 
Affiliation  Manav Rachna Dental College 
Address  Department of Orthodontics & Dentofacial Orthopedics Manav Rachna Dental College

Bhiwani
HARYANA
121004
India 
Phone  09802664902  
Fax    
Email  garimaarora483@gmail.com  
 
Details of Contact Person
Public Query  
Name  GARIMA ARORA 
Designation  Senior Lecturer 
Affiliation  Manav Rachna Dental College 
Address  Department of Orthodontics & Dentofacial Orthopedics Manav Rachna Dental College

Faridabad
HARYANA
121004
India 
Phone  09802664902  
Fax    
Email  garimaarora483@gmail.com  
 
Source of Monetary or Material Support  
Manav Rachna Dental College, Faridabad, Haryana 
 
Primary Sponsor  
Name  Manav Rachna Dental College 
Address  Aravali Hills, Sector 43, Faridabad, Haryana,121004 
Type of Sponsor  Research institution 
 
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 
Garima Arora  Manav Rachna Dental College, Aravali hills, sector 43, Faridabad  QG-9, Department of Orthodontics & Dentofacial Orthopedics
Faridabad
HARYANA 		 09802664902

garimaarora483@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manav Rachna Dental College Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed orthodontic appliance  Sample will be collected at 3 time intervals. T0- Before start of treatment T1- 1 year after start of treatment T2- 2 years after start of treatment 
Comparator Agent  No intervention  Sample will be collected before start of treatment 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  All Class I crowding cases require maxillary first premolar extraction. 
 
ExclusionCriteria 
Details  • Patients with relapsed malocclusion or have undergone any previous orthodontic treatment.
• Patients affected by any systemic disease or smoking habits.
• Patients with systematic disorders and medical contraindications.
• Patients with already established gingivitis.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
• A comparative analysis of oral microbiome between adolescents and adults will identify specific bacterial taxonomy responsible for gingivitis  • T0- Baseline
T1- 6 months
T2- 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
• The study will also establish the change in the complete microbial array during the orthodontic treatment in adolescents and adults  before the start of treatment (T1), During the treatment (T2), and completion of treatment (T3) 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   01/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - Proposals should be directed to [garimaarora483@gmail.com].

  6. For how long will this data be available start date provided 04-12-2026 and end date provided 04-12-2028?
    Response - Immediately following publication. No end date.

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

Summary

Aim: To evaluate and compare oral microbiome during fixed orthodontic therapy in young and adult patients and to correlate with the clinical parameters.

Objective: To evaluate oral microbiome during fixed orthodontic therapy in adolescent patients at three different observation times

Methodology: Study sample collection will be started after ethical clearance. For the biological sample collection. Supragingival plaque will be isolated using cotton and airdried. Supragingival plaque will be collected using a periodontal probe, and after collection, plaque will be dropped in an Eppendorf tube containing ionized molecular water and shaken until the plaque dislodged from the tip and into the tube. A sample will be collected at time intervals- before the start of treatment (T1), During the treatment (T2), and completion of treatment (T3)

Outcomes- A comparative analysis of oral microbiome between adolescent and adults may identify specific bacterial taxonomy responsible for periodontitis, gingivitis and white spot, thus aid in formulation of a targeted approach.

 
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