Clinical Evaluation of Posterior Direct Restoration in Adolescents

NCT ID: NCT03936855

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-09-30

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.

Conditions

Composite Resins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Incremental filling technique

Glass ionomer in the pulp chamber and incremental filling technique using composite resin

Group Type: ACTIVE_COMPARATOR

Direct composite resin

Intervention Type: PROCEDURE

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

Bulk Fill

Bulk fill composite resin filling all the cavity

Group Type: EXPERIMENTAL

Direct composite resin

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Coordination for the Improvement of Higher Education Personnel

OTHER

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Renata Afonso da Silva Pereira

OTHER

Sponsor Role: lead

Responsible Party

Renata Afonso da Silva Pereira

PHD student

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carlos J Soares, DDS,MS,PHD

Role: STUDY_CHAIR

Universidade Federal de Uberlândia

Locations

Universidade Federal de Uberlândia

Uberlândia, Minas Gerias, Brazil

Countries

Brazil

Other Identifiers

UFU001

Identifier Type: -

Identifier Source: org_study_id