Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Health
- Sponsor
- DMG Dental Material Gesellschaft mbH
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Caries progression rate
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The goal of the project is to investigate the clinical efficacy of management of early caries lesions by resin infiltration and to further scrutinize the patient stress experiences.
Detailed Description
The aim of this study is to test the clinical efficacy of caries infiltration to arrest proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test lesions) will progress significantly less than non infiltrated lesions (control lesions). Additionally, it was hypothesized that dental anxiety and stress related to caries infiltration will be significantly less than dental anxiety related to a conventional restorative procedure. The study will be a controlled clinical trial with a split mouth design and blind evaluation of the outcome (caries progression). Caries progression will be evaluated annually, 12, 24, and 36 months after treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •children with one tooth surface with active caries lesions
- •two primary molars with proximal lesion detected on the x-ray (scores 2 (E2) or 3 (D1) in Mejàre et al. scoring system with less depth
- •asigned informed consent.
Exclusion Criteria
- •children who do not cooperate during dental appointments
- •primary molars supposed to exfoliate in less than two years
- •lesions showing obvious cavitation or clear sings of inactivity
Outcomes
Primary Outcomes
Caries progression rate
Time Frame: 1 year
Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.
Secondary Outcomes
- Caries progression rate(2 years, 3 years)
- Stress reaction during treatment(Immediate)
- Caries risk(Baseline, 6 months, 1 year, 2 years, 3 years)