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CTRI Number  CTRI/2025/06/089273 [Registered on: 20/06/2025] Trial Registered Prospectively
Last Modified On: 17/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Which aligners attract less bacteria?A study for better oral health 
Scientific Title of Study   Biofilm adhesion properties of four different aligner materials - An experimental 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  DrMaha Srinithi 
Designation  Post graduate 
Affiliation  Karapaga Vinayaga Institute of Dental Sciences 
Address  Karapaga Vinayaga Institute of Dental Sciences,GST road,Chinnakolambakkam,Madhurandhagam,Chengalpattu Dist

Chennai
TAMIL NADU
603308
India 
Phone  7010259598  
Fax    
Email  srinithiselvaraj22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Muralidharan 
Designation  Professor 
Affiliation  Karapaga Vinayaga Institute of Dental Sciences 
Address  Karapaga Vinayaga Institute of Dental Sciences,GST road,Chinnakolambakkam,Madhurandhagam,Chengalpattu Dist

Chennai
TAMIL NADU
603308
India 
Phone  9841155144  
Fax    
Email  kidsorthodont09@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrMaha Srinithi 
Designation  Post graduate 
Affiliation  Karapaga Vinayaga Institute of Dental Sciences 
Address  Karapaga Vinayaga Institute of Dental Sciences,GST road,Chinnakolambakkam,Madhurandhagam,Chengalpattu Dist


TAMIL NADU
603308
India 
Phone  7010259598  
Fax    
Email  srinithiselvaraj22@gmail.com  
 
Source of Monetary or Material Support  
Karpaga vinayaga Institute of dental sciences,GST road,Chinnakolabakkam,palayanoor post,chengalpattu dist,Tamilnadu-603038 India 
 
Primary Sponsor  
Name  Maha srinithi 
Address  Karpaga vinayaga institute of dental sciences,GST road,chinnakolambakkam,palayanoor post,chengalpattu dist,Tamil nadu-6033038 India. 
Type of Sponsor  Other [self fund] 
 
Details of Secondary Sponsor  
Name  Address 
self fund  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 Maha Srinithi  Karpaga Vinayaga Institue of dental Sciences  Room No:9,Department of Orthodontics and dentofacial orthopedics
Chennai
TAMIL NADU 		 7010259598

srinithiselvaraj22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,KIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  clear aligner material - PETG   intervention period 30days 
Intervention  clear aligner material - polymethylmethacrylate  intervention period 30days 
Intervention  Clear aligner material - Polyurethane  intervention period 30 days 
Intervention  clear aligner material- Polyproylene  intervention period 30 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  patients with no maloclusion 
 
ExclusionCriteria 
Details  Below 18,
poor oral hygiene,
severely crowded dentition 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the four different aligner materials based on adhesion property of biofilm  Asssesd at 24 hours of wear of aligners 
 
Secondary Outcome  
Outcome  TimePoints 
To analyse the adhesion properties among various aligner materials between male & female  Assesed at 24 hours of wear of aligners 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/07/2025 
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="0"
Months="8"
Days="0" 
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 - 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 - Informed Consent Form

  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) -  once the study got completed, the link will be included

  6. For how long will this data be available start date provided 20-12-2025 and end date provided 15-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Clear orthodontic retainers are widely used in India as an aesthetically appealing alternative to traditional wire retainers. However, the formation of biofilm on retainer surfaces can have detrimental effects on oral health. This study aimed to evaluate and compare the biofilm formation on three commercially available clear orthodontic aligners commonly used in India. Methods: Four clear orthodontic aligners materials, including Polyethylene Terephthalate Gycol(PETG),polyurethane,polyproylene.polymethyl methacrylate were selected for this experimental study. Standardized specimens of each aligner material were fabricated according to manufacturer guidelines.Sample will be collected from the patients after 24 hours of wear. Scanning electron microscopy (SEM) is utilized to analyze the morphology of biofilms and quantify bacterial adhesion on the aligner surfaces. Image analysis software will be  employed to assess biofilm coverage and thickness. 
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