FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/085276 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 19/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effectiveness of two treatments: Decay preventive solution with a sugar substitute and with a milk protein derivative in children having cavities at an early age. 
Scientific Title of Study   Comparative Evaluation of the Antimicrobial Efficacy of Fluoride Varnish with Xylitol and Fluoride Varnish with CPP-ACP in children with Early Childhood Caries : A 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 Shivika Soral 
Designation  PG Student 
Affiliation  KM Shah Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Number-3, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University, Waghodia Road, Pipariya, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8619317281  
Fax    
Email  shivikasoral@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Bargale 
Designation  PG Guide 
Affiliation  KM Shah Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Number-3, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University, Waghodia Road, Pipariya, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  7016048359  
Fax    
Email  drseemabargale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivika Soral 
Designation  PG Student 
Affiliation  KM Shah Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Number-3, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University, Waghodia Road, Pipariya, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8619317281  
Fax    
Email  shivikasoral@gmail.com  
 
Source of Monetary or Material Support  
KM Shah Dental College and Hospital, Sumandeep Vidyapeeth deemed to be University, Vadodara, Gujarat, India Pin Code:391760 
 
Primary Sponsor  
Name  Dr Shivika Soral 
Address  Department of Pediatric and Preventive Dentistry, Number-3, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth deemed to be University, Pipariya,Waghodia, Vadodara,Gujarat,India Pin:391760 
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 Shivika Soral  KM Shah Dental College and Hospital  Department of Pediatric and Preventive Dentistry, Number-3, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University, Waghodia Road, Pipariya, Vadodara
Vadodara
GUJARAT 
8619317281

shivikasoral@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Early Childhood Caries 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fluoride Varnish with CPP-ACP  MI Varnish, is a superior fluoride varnish with 5% sodium fluoride or 22,600 ppm of fluoride and Recaldent (CPP-ACP), which incorporates the properties of fluoride along with remineralizing properties of CPP-ACP. The varnish will be applied at baseline and follow up will be done at 3 and 6 months. 
Intervention  Fluoride Varnish with Xylitol  FluoroDose varnish consists of 5% sodium fluoride or 22,600 ppm of fluoride with xylitol. The xylitol sweetener provides added anti-bacterial properties. The ADA considers fluoride varnish to be safe and efficacious as part of a caries prevention program.The varnish will be applied at baseline and follow up will be done at 3 and 6 months. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Children who have Early Childhood Caries (ECC).
2. Healthy children with a behaviour rating of 3 or 4 according to Frankl Scale.
3. Teeth with International Caries Detection and Assessment System (ICDAS) score 1-3.
4. Participants whose parents will give written consent for the study. 
 
ExclusionCriteria 
Details  1. The teeth with spontaneous pain, swelling, fistula, abscess or tenderness on percussion.
2. Children allergic fluoride.
3. Children with oral ulceration.
4. Children suffering from any illness or any systemic disease requiring special medical care. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The microbiological analysis will be done to assess the S mutans colonies after the application of fluoride varnish in children.  The follow up will be done at 3 and 6 months interval. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   15/07/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The aim of the study is to  assess and compare the Antimicrobial Efficacy of Fluoride Varnish with Xylitol and Fluoride Varnish with CPP-ACP in children with Early Childhood Caries. No In Vivo studies have been done for the age group 3-6 years, with Early Childhood Caries comparing Fluorodose and MI varnishes. Therefore, the need of the study is to check the antimicrobial effect of these fluoride varnishes as a preventive measure in children with ECC.

Methodology: Enrollment of all the participants will be done after they have met the inclusion criteria. The sample size is 22 participants in each group. Randomization will be done through computer-generated sequence (RESEARCH RANDOMIZER) and participants will be allotted to one of the two groups-Group A: FluoroDose Varnish with Xylitol and Group B: MI Varnish  with CPP-ACP. The plaque sample will be collected from 9-11 AM ; from the following four sites using separate toothpicks for the four sites for all the groups: Maxillary right molar – buccal surface, Maxillary incisor – labial surface, Mandibular incisor – labial surface and Mandibular left molar – lingual surface. The four tooth picks will be then placed in a single test tube with 1 ml of sterile saline and Streptococcus mutans colonies will be counted by streaking the samples on prepared mitis salivarius agar plates. After baseline plaque samples will be obtained from each participant, varnish application will be carried out for each participant in the respective groups with the applicator tips using paint on brush technique and as per the manufacturer’s instruction manual. The participants will be recalled for follow up at 3 and 6 months interval for the plaque sample collection and microbiological analysis .

 
Close