Performance of Universal Adhesive in Primary Molars: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Longevity of restoration
Study Overview
Brief Summary
The aim of this study is to evaluate the 18-month clinical performance of a multimode adhesive (Scotchbond Universal Adhesive, 3M ESPE, St Paul, MN, USA) in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at two university centers (UFSM and FOUSP). The sample will consist of 132 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal and occlusal-proximal surface. The sample will be randomly divided into two groups according to bonding approach: etch-and-rinse or self-etch strategy. The restorations will be clinically followed every 6 months for up to 18 months using the USPHS modified criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
Detailed Description
Randomized clinical trials of performance of universal adhesive in primary molars
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 5 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •active carious lesion in middle dentin limited to the occlusal or occluso-proximal surfaces of primary molars;
- •children (male or female) in good general health.
Exclusion Criteria
- •children who refuse or fail to cooperate with the completion of clinical procedure; - teeth without antagonist;
- •carious lesions in inner half of dentin;
- •presence of painful symptoms or signs of pulpal changes.
Arms & Interventions
Self-etch approach
Application of universal adhesive as self-etch mode
Intervention: Self-etch approach (Other)
Etch-and-rinse approach
Application of universal adhesive as etch-and-rinse mode
Intervention: Etch-and-rinse approach (Other)
Outcomes
Primary Outcomes
Longevity of restoration
Time Frame: 18-month follow up
The outcome of the study is the failure of restorations in primary teeth. Failures will be assessed by clinical evaluation and will be considered in the presence of loss of restoration or fracture requiring a reintervation (restoration repair or replacement) or symptoms requiring pulp intervention or tooth extraction.
Secondary Outcomes
No secondary outcomes reported
Investigators
Rachel de Oliveira Rocha
Rachel de Oliveira Rocha
Universidade Federal de Santa Maria