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CTRI Number  CTRI/2025/02/080119 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   visual and photographic assessment of remineralization of white spot lesion on primary front teeth intervention using self assembling peptide and sodium fluoride varnish in 3 to 6 years children A comparitive randomized clinical study 
Scientific Title of Study   Visual And Photographic Assessment Of Remineralizing Efficacy Of Self Assembling Peptide And Sodium Fluoride Varnish On White Spot Lesions In Primary Anterior Teeth: A Comparative Randomized Clinical 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 Shwetha N 
Designation  Post Graduate Student 
Affiliation  Government dental college and research institute 
Address  Deparment of pediatric and preventive dentistry,Government dental college and research institute, Bangalore, Victoria hospital campus

Bangalore
KARNATAKA
560002
India 
Phone  07026747822  
Fax    
Email  shwethan31598@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr J Nagarathna 
Designation  Assistant Professor 
Affiliation  Government dental college and research institute 
Address  Deparment of pediatric and preventive dentistry, Government dental college and research institute, Bangalore, Victoria hospital campus

Bangalore
KARNATAKA
560002
India 
Phone  9449631391  
Fax    
Email  nagarathnagiri_1975@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr J Nagarathna 
Designation  Assistant Professor 
Affiliation  Government dental college and research institute 
Address  Deparment of pediatric and preventive dentistry, Government dental college and research institute, Bangalore, Victoria hospital campus


KARNATAKA
560002
India 
Phone  9449631391  
Fax    
Email  nagarathnagiri_1975@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Dental College and research institute, Bangalore 
 
Primary Sponsor  
Name  Dr Shwetha N 
Address  Depart of pediatric and preventive dentistry, Government dental college and research institute, KR market , Bangalore 
Type of Sponsor  Other [nil] 
 
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 J Nagarathna  Government dental college and research institute  Deparment of pediatric and preventive dentistry ,government dental college and research institute , bangalore , victoria hospital campus beside victoria hospital b block ,k r market
Bangalore
KARNATAKA 
9449631391

nagarathnagiri_1975@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government dental college and research institute bangalore institutional ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  white spot lesions on primary anterior teeth 
Patients  (1) ICD-10 Condition: K026||Dental caries on smooth surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Self assembling peptide  application of self assembling peptide on white spot lesions on primary anterior teeth, photographs are taken pre and post intervention. 
Comparator Agent  sodium fluoride varnish  application of sodium fluoride varnish at 6month and 12 months and photographs are taken pre and post intervention. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  • Co-operative children, aged 3-6 years with primary dentition .

• Teeth presenting at least one non-cavitated, active( whitish opaque appearance with rough surface), visible with or without air drying .
• The initial caries of ICDAS II score 1 or 2 on labial aspect of primary anterior teeth.

• Subjects with no systemic diseases or medications affecting salivary flow.

• Subjects with photographs of high image quality.
 
 
ExclusionCriteria 
Details  • Subjects who had history of professional topical fluoride application or use of any remineralizing agents .
• Subjects who have GIC restorations adjacent to tooth with the white spot lesions .

• Subjects under tetracyclines or any other medications known to cause stains, had enamel hypoplasia, fluorosis or other developmental defects .
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. increase or decrease in area of white spot lesion pre and post intervention.  1 year 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
change in appearence of white spot lesions in pre and post photographs   1year 6months 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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 - NO
Brief Summary  

Early childhood caries(ECC) is a biofilm-mediated, multifactorial, dynamic disease induced by the imbalance between demineralization and remineralization of dental hard tissues.1 Caries progress when the equilibrium of demineralization and remineralization is tilted, leading to net mineral loss and white spot lesion(WSLs) formation.2 Since a lower level of mineralization and the thin enamel make primary teeth more susceptible to caries formation, effective control of initial lesions before cavitation is of utmost importance.3

Remineralization of the initial lesion is always a viable option that arrests or reverses the caries process at a lesion level which reduces the loss of sound tooth structure.4 Sodium fluoride varnish(NaF) is a professionally used topical fluoride preparation that is simple, relatively inexpensive and effective in controlling the progression of WSLs.5 However, it has been claimed that the effect of fluoride is limited to the outer 30um and does not enter a deeper subsurface demineralized zone, where remineralization is much needed for the affected enamel.6

Owing to this limitation seeking an alternative that diffuses deeply into the subsurface caries in a biomimetic way similar to the natural remineralization could be valuable. One such is the Self-assembling peptide(SAP11-4) which mimics the action of natural enamel proteins that aid in guided enamel regenerartion.7 Several methods exist for the detection and assessment of WSLs, visual and tactile method is commonly used for detection and photography is simple and effective for assessment. There are limited clinical studies evaluating the efficacy of SAP11-4 and NaF on primary teeth, henceforth this study is undertaken.

 
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