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
|
|
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
|
|
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 . |