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

NCT03733522 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2021-03-03

No results posted yet for this study

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%).

Conditions

  • Dental Caries in Children

Interventions

PROCEDURE

Rubber dam isolation

Local anesthesia, use of dental clamp and rubber dam, followed by restoration using universal adhesive system and bulkfill composite restoration

PROCEDURE

Relative isolation

No local anesthesia, use of cotton rollers and saliva ejector, followed by restoration using universal adhesive system and bulkfill composite restoration

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Daniela P Raggio, PhD · University of Sao Paulo

  • Isabel C Olegário, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-06-01
Completion
2021-03-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03733522 on ClinicalTrials.gov