NCT07112963

"Comparison of the Effects of Resin Infiltrant, Fluoride Varnish, and the Combined Application of Resin Infiltrant and Fluoride Varnish on Primary Molars in the Treatment of Proximal Non-Cavitated Carious Lesions in Children."

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sacide Duman · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

Purpose: This randomized controlled clinical trial aimed to compare the effectiveness of fluoride varnish, resin infiltrant, and their combination in treating superficial proximal carious lesions in primary molars of children aged 4 to 9 years. Materials and Methods: Twenty-six children with initial proximal caries (E1, E2, D1) on primary molars were randomly assigned to three groups: fluoride varnish only (F), resin infiltration only (RI), and resin infiltration combined with fluoride varnish (RI+F). Treatments were applied according to standardized protocols, and clinical and radiographic evaluations were conducted at 3, 6, 9, and 12 months.

Detailed description

This randomized controlled clinical trial investigates the comparative effectiveness of fluoride varnish, resin infiltrant, and their combined use in managing superficial proximal carious lesions in primary molars of children aged 4 to 9 years. A total of 26 pediatric patients presenting with initial proximal caries lesions classified as E1, E2, and D1 levels were enrolled. Participants were randomly allocated into three groups: fluoride varnish only (F), resin infiltration only (RI), and a combination of resin infiltration with fluoride varnish (RI+F). Interventions were applied according to standardized clinical protocols. Follow-up assessments, including clinical examinations and radiographic evaluations, were conducted at 3, 6, 9, and 12 months post-treatment to monitor lesion progression or regression. The primary outcome measure was the change in caries lesion status over time, evaluated through clinical and radiographic criteria.

Conditions

• Dental Caries
• Tooth Demineralization
• Pediatric Dentistry
• Molar, Deciduous

Interventions

Type	Name	Description
DRUG	Fluoride Varnish	Application of fluoride varnish to proximal surfaces of primary molars following standard clinical protocols to promote remineralization and arrest early carious lesions. Application of resin infiltrant material to proximal non-cavitated carious lesions in primary molars, performed according to manufacturer instructions to arrest lesion progression. Sequential application of resin infiltration followed by fluoride varnish on proximal surfaces of primary molars to maximize caries arrest and remineralization effects.

Timeline

• Start date: 2023-10-04
• Primary completion: 2025-11-01
• Completion: 2026-01-01
• First posted: 2025-08-08
• Last updated: 2026-03-27

Locations

1 site across 1 country: Turkey (Türkiye)