Overview

This trial is active, not recruiting.

Condition dental caries
Treatments adhesive system, restoration protocol
Sponsor University of Sao Paulo
Collaborator Universidade Federal de Sao Carlos
Start date February 2015
End date November 2016
Trial size 61 participants
Trial identifier NCT02389569, CAAE nº: 27790214.1.0000.541

Summary

Objective: The purpose of this study is to evaluate clinical performance of resin-based composite Class I and II restorations in association with Biosilicate. Methods: Eighty patients with carious lesions will be receive restorations in premolars and molars, which will be randomly allocated in four experimental groups: G1 (Biosilicate, Adper Single Bond 2 and IPS Empress Direct composite), G2 (Adper Single Bond 2 and IPS Empress Direct composite), G3 (Biosilicate, AdheSe and IPS Empress Direct composite) e G4 (AdheSE and IPS Empress Direct composite) — (n= 20 per group). Two trainer and calibrated evaluators fully blinded to the restorative technique used will be evaluate the restorations at 1 week (baseline), at 6, 12 and 18 months after placement using World Dental Federation (FDI) criteria. Data will be statistically analyzed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Four groups ( Two will be treat with Etch-and-Rinse Adhesive System and two will be treated with two step Self-Etch Adhesive System).
adhesive system Etch-and-rinse adhesive: Adper Single bond (3M, Brazil)
Etch-and-rinse and Self-etch adhesive system will be applied in volunteers that received different types of restoration protocol.
(Experimental)
Four groups ( Two will be treat with experimental Biosilicate and two will be the control groups).
restoration protocol Biosilicate (Vitrovita, Brazil)
Volunteers will be treated by two types of protocol restoration : 1) Biosilicate (powder) or 2) Control (without Biosilicate). In sequence, adhesive (self-etch or etch and rinse) and composite resin will be used for restoration.

Primary Outcomes

Measure
Clinical performance of Biosilicate in caries lesion using FDI evaluation criteria
time frame: 18 months

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

Inclusion Criteria: - Cavitated or non-cavitated active carious lesions in dentin (Class I and/or II) - Carious lesion in teeth with or without restoration in at least one tooth (upper or lower premolar and/or molar). - No history of spontaneous pain - Pulp vital tests positive - No evidence of periapical radiolucency Exclusion Criteria: - Compromised medical history - Periodontal disease - Pulp necrosis - Absence of antagonist teeth - Severe bruxism - Active orthodontic treatment - Teeth with cracks and premature contact. - Pregnancy

Additional Information

Official title A Prospective, Double-blind, Randomized, Group Controlled Clinical Study on the Use of Biosilicate Under Resin Composite Restorations in Caries Affected Teeth
Principal investigator Karen Pintado Palomino, MSc
Description Background: Dental caries has decreased in recent years, but is still the main oral health problem in developed and undeveloped industrialized countries. The purpose of this study is to evaluate clinical performance of resin-based composite Class I and II restorations in association with Biosilicate. Methods: Eighty patients with carious lesions will be receive restorations in premolars and molars, which will be randomly allocated in four experimental groups: G1 (Biosilicate, AdperSingle Bond 2 and IPS Empress Direct composite), G2 (Adper Single Bond 2 and IPS Empress Direct composite), G3 (Biosilicate, AdheSe and IPS Empress Direct composite) e G4 (AdheSE and IPS Empress Direct composite) — (n= 20 per group). To participate in the clinical trial, qualified subjects must meet for inclusion and exclusion criteria. Sixty-four (64) selected volunteers will be fully informed on the nature of the study and after had signed a Term of Acceptance defined by the Ethics Committee (FORP - USP), they will be invited to participate. Carious teeth will be cleaned with a pumice-water slurry and rubber cup to remove salivary pellicle and any bacterial plaque. As much as possible, local anesthesia will be. After caries removal (high and low-speed handpieces under abundant water irrigation), patients will be allocated randomly in the four experimental groups cited above. Final contouring and polishing of the restorations will be performed at the same appointment, using a fine-grit diamond bur (KG Sorensen), silicon carbide polisher (Viking Kit, KG Sorensen), silicone rubber tips (Viking Kit, KG Sorensen) flexible discs (Sof-Lex, 3M ESPE), and polishing pastes (Diamond Excel, FGM). Two trained and calibrated evaluators, fully blinded to the restorative techniques used, will be evaluating the restorations at baseline (one week after placement of restorations), after 06, 12 and 18 months using FDI criteria. All restorations will be photographed at every evaluation point. Esthetic, Functional and Biological proprieties will be used as key parameters determining the overall clinical success. Data will be analyzed.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo.