Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution

Caries Arrested Clinical Trial

Official title:

Arrest of Interproximal Caries Lesion in Primary Molars With 38% Silver Diamine Fluoride Solution and 5% Sodium Fluoride Varnish: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05791669
• Other study ID #: PGIDS/BHRC/21/13
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2021
• Est. completion date: November 8, 2022

Study information

• Verified date: November 2022
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. Each bitewing was scored based on ICCMS radiographic criteria and was compared (follow-ups to baseline)to check for caries arrest.

Interproximal caries included in this study, according to ICCMS criteria, were at stages- RA

• caries limited to outer half of enamel RA2 - caries limited to the inner half of enamel RA3
• caries limited to outer third of dentine RA4 - caries limited to middle third of dentine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 8, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

Inclusion Criteria:

1. Children aged 5 to 9 years.

2. Presence of at least 2 primary molars with interproximal caries.

3. Carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with ICCMSTM scoring (RA1, RA2, RA3, RB4).

Exclusion Criteria:

1. Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6).

3. Children or adolescents that refuse to participate in the study or present negative behaviours.

4. Teeth with premature hypermobility 5. Both physically and mentally disabled children

Related Conditions & MeSH terms

• Caries Arrested
• Heart Arrest

Intervention

Drug:
• Silver diamine fluoride
Silver diamine fluoride is a topical medication composed of 25% silver, 5% fluoride, 8% ammonia, and 62% Deionized water, used to treat and prevent dental caries and relieve dentinal hypersensitivity.
• Sodium fluoride varnish
It is a topical application with an active ingredient of 5% sodium fluoride(22,600ppm fluoride).it prolongs the contact time between the fluoride and tooth surface and promotes remineralization and inhibits demineralization.

Locations

Country	Name	City	State
India	Post graduate institute of dental sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries arrest	Assessment with bitewing radiographs based on ICCMS radiographic scoring system	12 months