NCT03936855

Clinical Evaluation of Posterior Direct Restoration in Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Renata Afonso da Silva Pereira · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Composite Resins

Interventions

Type	Name	Description
PROCEDURE	Direct composite resin	For both groups: The teeth will have the enamel surface conditioned with 37% phosphoric acid. For the restorative procedure, the same adhesive system will be used GROUP ACTIVE COMPARATOR 1. Insert resin-modified glass ionomer cement into the pulp chamber; 2. Complete the restoration by incremental technique using conventional composite resin in increments of 2mm; EXPERIMENTAL GROUP 1. Insert Bulk Fill composite inside the pulp chamber to the height of 5 mm; 2. Complete the insertion of the Bulk Fill resin to the limit of the caval surface angle in the occlusal

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-09-01
• Completion: 2018-09-01
• First posted: 2019-05-03
• Last updated: 2019-05-06

Locations

1 site across 1 country: Brazil