NCT05395065

Silver Diamine Fluoride Gel: Case Series

Evaluation of the Response of Caries Lesions in Dentin After Application of Silver Diamine Fluoride Gel: A Case Series

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 235 (actual)
• Sponsor: Advantage Silver Dental Arrest, LLC · Industry
• Sex: All
• Age: 3 Years – 4 Years
• Healthy volunteers: —

Summary

A clinical case series to determine the clinical response of dental caries lesions in primary teeth where 38% silver diamine fluoride gel is applied and cover with 2.5% sodium fluoride varnish. Additionally, to assess parent satisfaction with treatment with 38% silver diamine fluoride.

Detailed description

A clinical case series of 235 children ages 3 and 4 with severe early childhood caries where the lesions are treated with 38% silver diamine fluoride and covered with 2.5% sodium fluoride varnish at baseline and 6 months. The primary objective is to determine the response of dental caries lesions (caries arrest) into the dentin in primary teeth at one year of follow-up. The secondary objective is to assess parent satisfaction with treatment with 38% silver diamine fluoride and 2.5% sodium fluoride varnish.

Conditions

• Dental Caries in Children

Interventions

Type	Name	Description
DEVICE	Silver Diamine Fluoride/Sodium Fluoride Varnish	Application of dental caries arresting topical medication

Timeline

• Start date: 2022-07-11
• Primary completion: 2023-07-17
• Completion: 2024-01-29
• First posted: 2022-05-27
• Last updated: 2024-01-30

Locations

5 sites across 1 country: Peru

Regulatory

• FDA-regulated device study