"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."
NCT ID: NCT07112963
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
26 participants
INTERVENTIONAL
2023-10-04
2025-11-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fluoride Varnish Group
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.
Fluoride 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.
Resin Infiltration Group
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.
Fluoride 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.
Resin Infiltration + Fluoride Varnish Group
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.
Fluoride 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.
Interventions
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Fluoride 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
Known allergy to fluoride varnish or resin infiltrant materials
Systemic diseases affecting oral health or participation
Prior restorative treatment on the target teeth
4 Years
9 Years
ALL
No
Sponsors
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Sacide Duman
OTHER
Responsible Party
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Sacide Duman
Associate Professor
Locations
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Inonu University, Faculty of Dentistry
Malatya, Malatya, Turkey (Türkiye)
Countries
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References
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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.
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.
Other Identifiers
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2022/80
Identifier Type: -
Identifier Source: org_study_id
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