"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."

NCT07112963 | Completed

• 1 other identifier: 2022/80
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Fluoride varnish; Proximal caries; Pediatric dentistry; Resins, Synthetic

Outcome Measures

Primary Outcomes (1)

• Caries Lesion Progression

  The primary outcome is the clinical and radiographic assessment of proximal carious lesion progression or arrest in primary molars over a 12-month follow-up period. Lesion status will be evaluated at 3, 6, 9, and 12 months to determine treatment efficacy.

  12 months

Study Arms (3)

Fluoride Varnish Group

ACTIVE COMPARATOR

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.

Drug: Fluoride Varnish

Resin Infiltration Group

EXPERIMENTAL

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.

Drug: Fluoride Varnish

Resin Infiltration + Fluoride Varnish Group

EXPERIMENTAL

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.

Drug: Fluoride Varnish

Interventions

Fluoride Varnish DRUG

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.

Also known as: Resin Infiltration, Resin Infiltration and Fluoride Varnish Combination

Fluoride Varnish Group; Resin Infiltration + Fluoride Varnish Group; Resin Infiltration Group

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4-9 years
• Presence of non-cavitated proximal carious lesions in primary molars
• Consent obtained from parents or legal guardians

You may not qualify if:

• 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

Sponsors & Collaborators

• Sacide Duman: lead

Study Sites (1)

Inonu University, Faculty of Dentistry

Malatya, Malatya, 44000, Turkey (Türkiye)

Location

Related Publications (2)

• Paris S, Meyer-Lueckel H. Infiltrants inhibit progression of natural caries lesions in vitro. J Dent Res. 2010 Nov;89(11):1276-80. doi: 10.1177/0022034510376040. Epub 2010 Aug 25.

  PMID: 20739697 RESULT

• Martignon S, Ekstrand KR, Gomez J, Lara JS, Cortes A. Infiltrating/sealing proximal caries lesions: a 3-year randomized clinical trial. J Dent Res. 2012 Mar;91(3):288-92. doi: 10.1177/0022034511435328. Epub 2012 Jan 17.

  PMID: 22257664 RESULT

MeSH Terms

Conditions

Dental Caries; Tooth Demineralization

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Gizem Tıraşçı, Research ass.

  Inonu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study was conducted as an open-label trial. Neither participants, investigators, nor outcome assessors were blinded to group assignments due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants were randomly assigned into three parallel groups: fluoride varnish only, resin infiltration only, and a combination of resin infiltration and fluoride varnish. Each group received its designated intervention, and no crossover occurred between groups.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: October 4, 2023
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

TU (1)