Preventing the spread of tooth decay in preschool children by applying various fluoride varnishes

Phase 2

Not yet recruiting

• Conditions: Dental caries, unspecified,

• Registration Number: CTRI/2021/10/037395
• Lead Sponsor: Dr Mounashree N

Brief Summary

This is a Randomized Clinical Trail to be done to compare the effectiveness various fluoride varnishes in arresting cavitated dentinal lesions in preschool children with uncooperative behaviour. Twenty dentinal carious lesions of primary teeth selected for 38% SDF application and then Twenty dentinal carious lesions of primary teeth selected for sodium fluoride varnish application(bifluorid10 varnish).Baseline data to collected before fluoride application. Clinical assessment to be done after the fluoride application at 1 week follow up using WHO CPI probe, if carious lesion is soft on probing it indicated active carious lesion, if its hard on probing it indicates caries arrest, and then the data is collected. If the caries activity is present further treatment of caries excavation and restoration is advised. In case of caries arrest cavitated lesion to be restored with glass ionomer cement.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• •Children aged between 3-5 years from either gender.
• •Dental Caries with active dentinal carious lesion in children.
• •Parents giving consent for the study.
• •At least 1 carious lesion as deï¬ned by the International Caries Detection and Assessment System (ICDAS).
• Using ICDAS, lesions were categorized as active (soft) cavitated carious lesions in the primary dentition, extending into the dentin (ICDAS 5 or 6).

Exclusion Criteria

• •Children who received fluoride topical application during last 48 hours.
• •Children with special health care needs.
• •Tooth with an abscess, symptoms of irreversible pulpitis, or a mobile tooth.
• •Children who were on antibiotic therapy within past 3 months.
• •Children with known sensitivity to silver or other heavy-metal ion were excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in caries activity	1week

Secondary Outcome Measures

Name	Time	Method
Arrest of Caries lesion	1week

Trial Locations

Locations (1)

Rajarajeswari Dental College and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Rajarajeswari Dental College and Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Nagarathna C

Principal investigator

9845581779

shaanrathna@gmail.com