NCT03733522: IsolationC3

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

Completed NA Last updated 3 March 2021

What this trial tests

NA trial testing Rubber dam isolation in Dental Caries in Children in 93 participants. Completed in 1 March 2021.

Timeline

1 December 2018

Primary endpoint
1 June 2019

1 March 2021

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	93
Start date	1 December 2018
Primary completion	1 June 2019
Estimated completion	1 March 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Rubber dam isolation
• Relative isolation

Conditions studied

• Dental Caries in Children — all drugs for Dental Caries in Children →

Sponsor

University of Sao Paulo

Who can join

Adults 4 to 10, any sex, with Dental Caries in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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%).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Use of rubber dam versus cotton roll isolation on composite resin restorations' survival in primary molars: 2-year results from a non-inferiority clinical trial.
   Olegário IC, Moro BLP, Tedesco TK, Freitas RD, et al · · 2022 · cited 15× · PMID 36217147 · DOI 10.1186/s12903-022-02449-y
2. Rubber dam isolation increases the costs and does not impact on composite resin restorations’ survival in primary teeth. 2-year results from a non-inferiority clinical trial
   Olegário IC, Moro BLP, Tedesco TK, Freitas RD, et al · · 2022 · DOI 10.21203/rs.3.rs-1537801/v1