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Isolation of the Operative Field Influences the Survival Rate of Composite Restorations

2018-11-13 18:11:20 | BioPortfolio

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. Two hundred (200) 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%).

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:

Two hundred (200) 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.

The sample calculation was performed based on the primary outcome of the randomized clinical trial, which is the longevity of composite resin restorations in deciduous teeth. For this calculation, a 3-year failure rate of approximately 5% for composite resin restorations reported by a systematic review [5] was considered. Considering the hypothesis of non-inferiority between the groups and an inferiority limit of 10% between the groups, we reached the number of 118 restorations. As a child can contribute with more than one restoration, 40% was added to this value (n = 166). 20% for possible sample losses was added to this number, a minimum of 200 restorations were reached.

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%).

Study Design

Conditions

Dental Caries in Children

Intervention

Rubber dam isolation, Relative isolation

Status

Not yet recruiting

Source

University of Sao Paulo

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-11-13T18:11:20-0500

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Medical and Biotech [MESH] Definitions

Sheets of latex rubber punched and placed over the teeth during dental procedures to isolate the field of operation from the rest of the oral cavity (Jablonski; Illustrated Dictionary of Dentistry, 1982). Rubber dams are useful in preventing the swallowing of instruments or restorations during dental work.

The segregation of patients with communicable or other diseases for a specified time. Isolation may be strict, in which movement and social contacts are limited; modified, where an effort to control specified aspects of care is made in order to prevent cross infection; or reverse, where the patient is secluded in a controlled or germ-free environment in order to protect him or her from cross infection.

The predisposition to tooth decay (DENTAL CARIES).

Diagnostic tests conducted in order to measure the increment of active DENTAL CARIES over a period of time.

The giving of attention to the special dental needs of children, including the prevention of tooth diseases and instruction in dental hygiene and dental health. The dental care may include the services provided by dental specialists.

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