"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."

Sacide Duman

Status: Active, not recruiting

Conditions: Tooth Demineralization; Dental Caries; Pediatric Dentistry; Molar, Deciduous

Treatments: Drug: Fluoride Varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT07112963

2022/80

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 4 and 9 years

Presence of initial proximal carious lesions (E1, E2, D1) on primary molars

Generally healthy children without systemic diseases

Consent obtained from parents or legal guardians

Exclusion criteria

• Cavitated or advanced proximal carious lesions

Known allergy to fluoride varnish or resin infiltrant materials

Systemic diseases affecting oral health or participation

Prior restorative treatment on the target teeth

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

Fluoride Varnish Group

Active Comparator group

Description:

Participants in this group receive only fluoride varnish applications according to standard clinical protocols. The treatment aims to remineralize early proximal carious lesions and prevent progression.

Treatment:

Drug: Fluoride Varnish

Resin Infiltration Group

Experimental group

Description:

Participants in this group receive resin infiltration treatment alone, applied following manufacturer guidelines and standardized procedures, aiming to arrest or reverse early enamel carious lesions.

Treatment:

Drug: Fluoride Varnish

Resin Infiltration + Fluoride Varnish Group

Experimental group

Description:

Participants in this group receive a combined intervention of resin infiltration followed by fluoride varnish application. The combined treatment is intended to maximize caries arrest and promote remineralization of proximal lesions.

Treatment:

Drug: Fluoride Varnish