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CTRI Number  CTRI/2023/12/060589 [Registered on: 20/12/2023] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Antimicrobial primer versus Regular primer to prevent early caries in orthodontically treated patients  
Scientific Title of Study   Effect of Organoselenium-containing Antimicrobial Primer on Prevention of White Spot Lesions: A Split-mouth, Controlled Clinical Trial 
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 Ritu Gupta 
Designation  First year postgraduate scholar 
Affiliation  Indira Gandhi Institute of Dental Sciences, Pondicherry 
Address  Department of Orthodontics and Dentofacial Orthopaedics, Indira Gandhi Institute of Dental Sciences, SBV Campus, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  08170066875  
Fax    
Email  ritugupta0102@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pavithranand A 
Designation  Professor and Head of the Department 
Affiliation  Indira Gandhi Institute of Dental Sciences, Pondicherry 
Address  Department of Orthodontics and Dentofacial Orthopaedics, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth Campus, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9443183590  
Fax    
Email  pavithranandammayappan@igids.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Pavithranand A 
Designation  Professor and Head of the Department 
Affiliation  Indira Gandhi Institute of Dental Sciences, Pondicherry 
Address  Department of Orthodontics and Dentofacial Orthopaedics, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth Campus, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9443183590  
Fax    
Email  pavithranandammayappan@igids.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Ritu Gupta 
Address  Department of Orthodontics and Dentofacial Orthopaedics, Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry 607402 
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 Ritu Gupta  Indira Gandhi Institute of Dental Sciences  Department of Orthodontics and Dentofacial Orthopaedics, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth Campus, Pondicherry
Pondicherry
PONDICHERRY 		 08170066875

ritugupta0102@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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, (2) ICD-10 Condition: M264||Malocclusion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Non-selenium Primer  Transbond primer for one year 
Intervention  Selenium Primer  organoselenium containing antimicrobial primer for one year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Age group 18 years and above.
Patients with malocclusion in the permanent dentition and requiring fixed orthodontic treatment.
Good oral hygiene status
Full eruption of posterior teeth
 
 
ExclusionCriteria 
Details  Congenitally missing or impacted teeth.
Teeth extracted due to caries.
Presence of active carious lesion or enamel hypoplasia
Previous history of active orthodontic treatment or extractions
Patient with growth and developmental anomaly or general diseases
History of any cosmetic allergy
Heavy restorations; periodontal diseases, abnormal oral conditions, history of smoking
Enamel demineralization or fluorosis staining or bleaching or fluoridation.
Severe crowding >6 mm or severely rotated teeth (limiting the appearance of buccal surfaces)
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduced formation of White Spot Lesions (WSLs) during fixed orthodontic treatment with organoselenium primer  white spot lesions will be assessed every 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
early detection and prevention of white spot lesions in fixed orthodontic treatment  one year 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   24/12/2023 
Date of Study Completion (India) 20/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/03/2024 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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  

Formation of White Spot Lesions is a common unwanted adverse effect of fixed orthodontic therapy. This randomized clinical trial is to assess the ability of an organoselenium-containing primer to prevent demineralization and formation of White Spot Lesions in comparison to a routinely used primer during orthodontic treatment with fixed appliances around orthodontic brackets, by using visual inspection and photographic images.

 
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