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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gizem Tıraşçı, Research ass. | Inonu University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inonu University, Faculty of Dentistry | Malatya | Malatya | 44000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20739697 | Result | 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. | |
| 22257664 | 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. |
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The individual participant data (IPD) from this study will be shared in a de-identified form. Data will be made available upon reasonable request to the corresponding author after publication of the primary results. Access will be granted following approval of a data use agreement and ethics compliance.
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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.
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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.
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D017001 | Tooth Demineralization |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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