Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Caries progression rate
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 5 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Resin infiltration". Teeth randomized into this arm do not recieve any special treatment except general oral nonivasiv treatment (flossing and brushing). Patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.
Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.
Intervention: Control (Device)
Resin infiltration
This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Control". Teeth in this arm are treated by the resin infiltration technique using Icon (DMG, Germany) according to manufactures´ instructions. In addition patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.
Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.
Intervention: Resin infiltration (Device)
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 risk(Baseline, 6 months, 1 year, 2 years, 3 years)
- Caries progression rate(2 years, 3 years)
- Stress reaction during treatment(Immediate)