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OpenTrials
Completed

NCT Number: 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."

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.

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Key information

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University, Faculty of Dentistry

Malatya, 44000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 4-9 years
  • Presence of non-cavitated proximal carious lesions in primary molars
  • 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

Treatment and study plan

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.

Other names: Resin Infiltration, Resin Infiltration and Fluoride Varnish Combination

Primary outcomes

  1. Caries Lesion Progression

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Sacide Duman

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 8, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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