Isolation of the Operative Field Influences the Survival Rate of Composite Restorations
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the survival of direct composite resin restorations in
      primary molars using different methods of isolation of the operative field: absolute
      isolation (local anesthesia, use of dental clamp and rubber dam) and relative isolation
      (cotton rollers and saliva ejector) by a randomized clinical trial. All composite
      restorations will be performed on children aged 4 to 10 years who present at least one dentin
      caries lesion or restoration needing replacement, without pulp involvement in a primary
      tooth. The treatments will be performed in the dental clinic of the University of São Paulo
      (FOUSP) by trained operators. The teeth will be randomized between the groups: Absolute
      Isolation (AI) and Relative Isolation (IR) and restored with composite resin (Scotchbond
      Universal Adhesive adhesive system and Filtek BulkFill composite resin - 3M ESPE) stratified
      by surface (single or multi surface). Restoration evaluation will be performed after 6, 12,
      18, and 24 months by a blind, trained and calibrated examiner. As a primary outcome, the
      survival of the restorations will be evaluated. The secondary outcomes involve the procedure
      time (in minutes), professional and material cost (in Brazilian reais), as well as the
      cost-effectiveness of the restorations and the discomfort reported by the patient (measured
      using the Wong-Baker scale). The Kaplan-Meier survival analysis and log-rank test will be
      applied to the survival of the restoration. All variables will be modeled and compared with a
      Cox regression model of shared fragility. The discomfort reported by the patient will be
      analyzed by Ordinal Logistic Regression (α = 5%).
    

Detailed description: 
      Objective:

      The aim of this study is to evaluate the survival of direct composite resin restorations in
      primary molars using different methods for isolation of the operative field: absolute
      isolation (local anesthesia, use of dental clamp and rubber dam) and relative isolation
      (cotton rollers and saliva ejector) by a randomized clinical trial.

      Materials and Methods:

      All composite restorations will be performed on children aged 4 to 10 years who present at
      least one dentin caries lesion or restoration needing replacement, without pulp involvement
      in a primary tooth. The treatments will be performed in the dental clinic of the University
      of São Paulo (FOUSP) by trained operators. The teeth will be randomized between the groups:
      Absolute Isolation (AI) and Relative Isolation (IR) and restored with composite resin
      (Scotchbond Universal Adhesive adhesive system and Filtek BulkFill composite resin - 3M ESPE)
      stratified by surface (single or multi surface).

      Restoration evaluation will be performed after 6, 12, 18, and 24 months by a blind, trained
      and calibrated examiner.

      As a primary outcome, the survival of the restorations will be evaluated. The secondary
      outcomes involve the procedure time (in minutes), professional and material cost (in
      Brazilian reais), as well as the cost-effectiveness of the restorations and the discomfort
      reported by the patient (measured using the Wong-Baker scale).

      The Kaplan-Meier survival analysis and log-rank test will be applied to the survival of the
      restoration. All variables will be modeled and compared with a Cox regression model of shared
      fragility. The discomfort reported by the patient will be analyzed by Ordinal Logistic
      Regression (α = 5%).
    

Intervention name(s): Rubber dam isolation; Relative isolation
Intervention type(s): Procedure; Procedure
Intervention description(s): Local anesthesia, use of dental clamp and rubber dam, followed by restoration using universal adhesive system and bulkfill composite restoration; No local anesthesia, use of cotton rollers and saliva ejector, followed by restoration using universal adhesive system and bulkfill composite restoration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment