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CTRI Number  CTRI/2025/08/093054 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 23/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   comparation of microorganism in patients treated with clear aligners and Fixed metal orthodontic appliances: A prospective study 
Scientific Title of Study   Comparative evaluation of biofilm microorganisms in patients treated with clear aligners and metal fixed orthodontic appliances: 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  Dr Roopa  
Designation  2nd year MDS PG student 
Affiliation  SDM College of Dental Sciences and Hospital Shri Dharmasthala Manjunatheshwara University  
Address  ORTHODONTIC DEPARTMENT ROOM NO 12 ,SDM College of Dental Sciences and Hospital Shri Dharmasthala Manjunatheshwara University Sattur
ORTHODONTIC DEPARTMENT ROOM NO 12 SDM College of Dental Sciences and Hospital Shri Dharmasthala Manjunatheshwara University Sattur
Dharwad
KARNATAKA
580009
India 
Phone  9164359138  
Fax    
Email  roopsbs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Shrinivas.M.Basavaraddi 
Designation  Professor 
Affiliation  SDM College of Dental Sciences and Hospital Shri Dharmasthala Manjunatheshwara University  
Address  Orthodontics and orthopedics department SDM College of Dental Sciences and Hospital Shri Dharmasthala Manjunatheshwara University Sattur
BASAVANAGAR PART 2, HALIYAL ROAD, DHARWAD
Dharwad
KARNATAKA
580009
India 
Phone  9449824324  
Fax    
Email  drshrinivas6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Roopa  
Designation  2nd year MDS 
Affiliation  SDM College of Dental Sciences and Hospital Shri Dharmasthala Manjunatheshwara University  
Address  SDM College of Dental Sciences and Hospital Shri Dharmasthala Manjunatheshwara University Sattur

Dharwad
KARNATAKA
580009
India 
Phone  9164359138  
Fax    
Email  roopsbs@gmail.com  
 
Source of Monetary or Material Support  
Sdm college of dental science and hospital dharwad 
 
Primary Sponsor  
Name  Dr Roopa 
Address  SDM College of Dental Sciences and Hospital Shri Dharmasthala Manjunatheshwara University Sattur 
Type of Sponsor  Other [self] 
 
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 Roopa  sdm college of dental sciences and hospital  Department orthodontics and dentofacial orthopedics ,Room no 12,SDM College of Dental Sciences and Hospital Shri Dharmasthala Manjunatheshwara University Sattur
Dharwad
KARNATAKA 		 09164359138

roopsbs@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM College of Dental Sciences and Hospital Institutional ethical committee   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, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Patient undergoing fixed metal orthodontic appliance treatment and
clear aligner treatment.
2.No missing first molars and lateral incisors. No crowns or fixed
bridges
3. Healthy subjects without any systemic diseases and no active dental
caries, no gingivitis and no periodontitis. Before treatment, patients
with periodontal probing depth less than 3mm and no periodontal
attachment loss will be included
4. Have good oral hygiene and periodontal health
5. No intake of antibiotics or hormones 1 month before joining the
study.
6.The gingival margin of the clear aligner is above the gingiva.
7. One month before baseline examination, all included patients
underwent subgingival ultrasonic scaling.  
 
ExclusionCriteria 
Details  1 Patient with history of Xerostomia, hyposalivation.
2 Smokers and Pregnant women.
3 Subjects under any medications that could affect the antibiotic
sensitivity during the previous six months before joining to study.
4 Patients who are under analgesic medication or NSAIDs will be
excluded.
5 Cleft palate and cleft lip patients
6 Patients with ceramic brackets were excluded.
7 Due to ongoing H3N2outbreak, subjects with cough, cold, sore
throat, breathlessness, fever or COVID symptoms will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The awareness and understanding of oral hygiene aspects during orthodontic treatment using different appliances like metal fixed appliances, clear aligners will help the clinician to make a decision on the choice of orthodontic appliance for treating patients in a better manner with less adverse effects on gingival and periodontal health.  at baseline(t1) , 6 months (t2)  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the plaque and gingival indices during
treatment with metal fixed appliances and clear aligners. 		 two time points:
Before orthodontic treatment (T0) and 6 months (T1). 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   23/11/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 WE HAVE NOT STARTED THE TRIAL WE ARE WAITING FOR CTRI NO AND ONCE WE START WE WILL UPLOAD 
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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [roopsbs@gmail.com].

  6. For how long will this data be available start date provided 25-01-2025 and end date provided 20-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary
Modification(s)  		 Comparing biofilm microorganisms in patients treated with clear aligners and metal fixed orthodontic treatment a prospective study at 2 time interval before (t0) and 6months after (t1) .  
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