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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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%).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cost-efficacy Between ART and Composite Resin Restorations in Primary Molars

NCT02562456

Dental Caries

UNKNOWN NA

Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Two Ways to Avoid Saliva Contamination

NCT01924611

Dental Caries

COMPLETED NA

Clinical Performance and Psychological Impact of Colored Restorations Cement in Primary Molars

NCT05557682

Pediatric Dentistry

COMPLETED

Effectiveness of ART and Conventional Treatment - Practice-based Clinical Trial

NCT02568917

Dental Caries

SUSPENDED NA

Effectiveness of Sealing Dental Caries

NCT02584218

Dental Caries

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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%).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Caries in Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Only the evaluator of the restorations will be blind to the type of treatment (absolute or relative isolation). As the procedures are different, it will not be possible to blind operators and patients.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rubber dam isolation

Absolute isolation

* local anesthesia
* use of dental clamp and rubber dam
* restoration using Universal Adhesive in a self etch mode (Single Bond Universal - 3M ESPE) and bulkfill composite resin (Filtek Bulkfill - 3M ESPE)

Group Type ACTIVE_COMPARATOR

Relative isolation

Intervention Type PROCEDURE

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

Relative isolation

Relative isolation

* no local anesthesia
* use of cotton roll and saliva ejector
* restoration using Universal Adhesive in a self etch mode (Single Bond Universal - 3M ESPE) and bulkfill composite resin (Filtek Bulkfill - 3M ESPE)

Group Type EXPERIMENTAL

Rubber dam isolation

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rubber dam isolation

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

Intervention Type PROCEDURE

Relative isolation

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* who have sought treatment in the University;
* between 4 and 10 years of age;
* with at least one dentin caries lesion without pulp involvement (ICCMS C score);
* need for restoration replacement diagnosed by FDI criteria or CARS criteria;
* absence of pulp involvement diagnosed by interproximal radiography (presence of dentin layer between the caries lesion and the pulp chamber).

Exclusion Criteria

* children whose parents did not agree to participate in the study:
* children who did not agree to participate or had behavioral problems during the initial consultations.
* signs or symptoms of pulp pathology: spontaneous pain, pulp exposure, abscess or fistula near the tooth to be included, mobility or presence of communication between the caries lesion and the pulp (evaluated by interproximal digital radiography of the diagnosis).

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No