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CTRI Number  CTRI/2025/10/095736 [Registered on: 08/10/2025] Trial Registered Prospectively
Last Modified On: 07/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two methods of fixing braces on front teeth to find which one causes fewer white spots and less bacteria. 
Scientific Title of Study   Evaluation of white spot enamel lesion and bacterial adherence of Streptococcus mutans on maxillary anterior teeth following orthodontic bonding with primer and primer-free protocol: A randomized controlled trial 
Trial Acronym  wsl 
Secondary IDs if Any  
Secondary ID  Identifier 
VMSDC/IEC/Approval No.364   Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR VANDANA A 
Designation  Postgraduate 
Affiliation  Vinayaka Missions Sankarachariyar Dental College 
Address  Vinayaka Missions Sankarachariyar Dental College, Sankari Main Road NH 47, Ariyanoor, Salem 636308, Tamil Nadu, India.

Salem
TAMIL NADU
636308
India 
Phone  9688886898  
Fax    
Email  mailvandanaarun@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR THANGABALU R 
Designation  co-guide 
Affiliation  Vinayaka Missions Sankarachariyar Dental College 
Address  Vinayaka Missions Sankarachariyar Dental College, Sankari Main Road NH 47, Ariyanoor, Salem 636308, Tamil Nadu, India.

Salem
TAMIL NADU
636308
India 
Phone  9384037975  
Fax    
Email  drbalamds93@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR THANGABALU R 
Designation  co-guide 
Affiliation  Vinayaka Missions Sankarachariyar Dental College 
Address  Vinayaka Missions Sankarachariyar Dental College, Sankari Main Road NH 47, Ariyanoor, Salem 636308, Tamil Nadu, India.

Salem
TAMIL NADU
636308
India 
Phone  9384037975  
Fax    
Email  drbalamds93@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DR.VANDANA A 
Address  Vinayaka Missions Sankarachariyar Dental College, Sankari Main Road (NH-47), Ariyanoor, Salem - 636308, Tamil Nadu, India.  
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 
DRVANDANAA  VINAYAKA MISSIONS SANKARACHARIYAR DENTAL COLLEGE  VINAYAKA MISSIONS SANKARACHARIYAR DENTAL COLLEGE Sankari Main Road (NH-47), Ariyanoor, Salem - 636308, Tamil Nadu, India.
Salem
TAMIL NADU 		 9688886898

mailvandanaarun@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE OF VMSDC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Those seeking orthdontic treatment at VMSDC 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Orthodontic bracket bonding with primer  it is a split mouth trial where comparator group is bonded with primer and the outcomes for white spot lesion and streptococcus mutans adherence is assessed 
Intervention  orthodontic bracket bonding without primer  it is a split mouth trial where intervention group is bonded without primer and the outcomes for white spot lesion and streptococcus mutans adherence is assessed 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Patients in age group between 18-30 years
Patients requiring conventional fixed appliance therapy.
Mild irregularity index
Absence of enamel defects on visual examination
Patients with Oral Hygiene Index -Simplified score of 0.0 to 1.2 (good) and 1.3 to 3.0 (fair).
 
 
ExclusionCriteria 
Details  Patients with craniofacial anomalies.
-Patients requiring orthognathic surgery.
-Patients with congenital as well as developmental enamel defects 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To quantify the adherence of Streptococcus Mutans on maxillary anterior teeth following orthodontic bonding with and without the use of primer
 		 Baseline, and after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of white spot enamel lesions on etched maxillary anterior teeth with & without the use of primer  baseline & 6 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "19"
Final Enrollment numbers achieved (India)="19" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/10/2025 
Date of Study Completion (India) 02/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This is a double blinded, split mouth and randomized controlled trial to evaluate white spot enamel lesion and bacterial adherence of Streptococcus mutans on maxillary anterior teeth following orthodontic bonding with primer and primer-free protocol. It is conducted at VMSDC ,Salem. The primary outcome is to quantify Streptococcus mutans adherece on anterior teeth and the secondary objective is to record white spot enamel lesion. Streptococcus mutans quantification will be done using RT-PCR by using plaque sample collected surrounding the brackets.  Secondary outcome is assessed by Visual examination surrounding the brackets.

 
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