Clinical Evaluation of Posterior Direct Restoration in Adolescents

Not Applicable

Completed

• Conditions: Composite Resins
• Interventions: Procedure: Direct composite resin

• Registration Number: NCT03936855
• Lead Sponsor: Renata Afonso da Silva Pereira

Brief Summary

The present study aims to evaluate the performance of direct restorations with bulk fill resins in molars with great structural loss, with endodontic treatment. The behavior of class II restorations in 68 molars endodontically treated with bulk fill resin and incremental technique will be evaluated by means of a randomized clinical trial with a two-year follow-up. This project aims to evaluate the performance of this new restorative strategy that can greatly contribute to restorations of posterior teeth.

Detailed Description

Sixty-eight endodontically treated molars were restored in 54 adolescents (10-18 years old, mean= 14.0 +- 2.4). Teeth were randomly assigned to the incremental filling technique (Filtek Z230/Vitremer, 3M-ESPE, n = 31) or high viscosity bulk fill technique (Filtek Bulk Fill Posterior, 3M-ESPE, n = 37). The restorations were clinically evaluated at baseline, 12 and 24 months by two independent raters using modified United States Public Health Service criteria. Data analysis included descriptive statistics, Mann-Whitney and Friedman non-parametric tests, and Generalized Estimating Equation (GEE) analysis.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2017-09
• Study Completion: 2018-09
• Status Verified: 2019-05
• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-01
• Study First Posted: 2019-05-03
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Adolescents with necessity of endodontic treatment in molar teeth, to be aged between 10 and 18 years;
• Patients that require direct restorations in Class II MOD cavities in molar teeth;
• Patients with medical history that does not compromise the evolution of the results;
• Patients that have a habit of oral hygiene involving brushing teeth at least once a day;
• Patients that have normal periodontal condition against the probing parameters.

Exclusion Criteria

• Patients with some chronic disease with oral manifestations;
• Patients who present some serious oral pathology;
• Patients with no oral hygiene;
• Patients with allergies to any material that will be used on this study;
• Patients presenting with signs or symptoms of bruxism and dental tightening;
• Patients with teeth that will be used as a pillar for removable prosthesis or fixed partial dentures;
• Patients with teeth with porcelain restorations directly opposite the tooth that will receive the restoration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incremental filling technique	Direct composite resin	Glass ionomer in the pulp chamber and incremental filling technique using composite resin
Bulk Fill	Direct composite resin	Bulk fill composite resin filling all the cavity

Primary Outcome Measures

Name	Time	Method
restoration failure	2 years	material fraction

Secondary Outcome Measures

Name	Time	Method
marginal staining	2 years	color alteration in the adhesive interface

Trial Locations

Locations (1)

Universidade Federal de Uberlândia; 🇧🇷 Uberlândia, Minas Gerias, Brazil