"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."
- Conditions
- Dental CariesPediatric DentistryTooth DemineralizationMolar, Deciduous
- Interventions
- Drug: Fluoride Varnish
- Registration Number
- NCT07112963
- Lead Sponsor
- Sacide Duman
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluoride Varnish Group Fluoride Varnish 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. Resin Infiltration + Fluoride Varnish Group Fluoride Varnish 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. Resin Infiltration Group Fluoride Varnish 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.
- Primary Outcome Measures
Name Time Method Caries Lesion Progression 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Inonu University, Faculty of Dentistry
🇹🇷Malatya, Turkey
Inonu University, Faculty of Dentistry🇹🇷Malatya, Turkey