Clinical Evaluation of Posterior Direct Restoration in Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Composite Resins
• Intervention / Treatment: Procedure: Direct composite resin

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerias
    • Uberlândia, Minas Gerias, Brazil, 38405320
      • Universidade Federal de Uberlândia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Incremental filling technique; Glass ionomer in the pulp chamber and incremental filling technique using composite resin	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; Insert resin-modified glass ionomer cement into the pulp chamber;; Complete the restoration by incremental technique using conventional composite resin in increments of 2mm; EXPERIMENTAL GROUP; Insert Bulk Fill composite inside the pulp chamber to the height of 5 mm;; Complete the insertion of the Bulk Fill resin to the limit of the caval surface angle in the occlusal
EXPERIMENTAL: Bulk Fill; Bulk fill composite resin filling all the cavity	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; Insert resin-modified glass ionomer cement into the pulp chamber;; Complete the restoration by incremental technique using conventional composite resin in increments of 2mm; EXPERIMENTAL GROUP; Insert Bulk Fill composite inside the pulp chamber to the height of 5 mm;; Complete the insertion of the Bulk Fill resin to the limit of the caval surface angle in the occlusal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
restoration failure	material fraction	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal staining	color alteration in the adhesive interface	2 years

Collaborators and Investigators

• Sponsor: Renata Afonso da Silva Pereira
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Fundação de Amparo à Pesquisa do estado de Minas Gerais; Coordination for the Improvement of Higher Education Personnel
• Investigators: Study Chair: Carlos J Soares, DDS,MS,PHD, Universidade Federal de Uberlândia

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (ACTUAL): May 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UFU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No