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.
- Conditions
- Early Childhood CariesDental caries, unspecified,
- Registration Number
- CTRI/2025/04/085276
- Lead Sponsor
- Dr Shivika Soral
- 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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 44
- Children who have Early Childhood Caries (ECC).
- Healthy children with a behaviour rating of 3 or 4 according to Frankl Scale.
- Teeth with International Caries Detection and Assessment System (ICDAS) score 1-3.
- Participants whose parents will give written consent for the study.
- The teeth with spontaneous pain, swelling, fistula, abscess or tenderness on percussion.
- Children allergic fluoride.
- Children with oral ulceration.
- Children suffering from any illness or any systemic disease requiring special medical care.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method
Trial Locations
- Locations (1)
KM Shah Dental College and Hospital
🇮🇳Vadodara, GUJARAT, India
KM Shah Dental College and Hospital🇮🇳Vadodara, GUJARAT, IndiaDr Shivika SoralPrincipal investigator8619317281shivikasoral@gmail.com