Dental Caries, Molar, Deciduous, Pediatric Dentistry, Tooth Demineralization
Conditions
Keywords
Fluoride varnish, Proximal caries, Pediatric dentistry, Resins, Synthetic
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.
Interventions
DRUGFluoride 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.
Sponsors
Sacide Duman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRGizem Tıraşçı, Research ass.
Inonu University
Outcome results
None listed