Clinical Evaluation of Posterior Direct Restoration in Adolescents

NCT03936855 | Completed

• 1 other identifier: UFU001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Composite Resins

Outcome Measures

Primary Outcomes (1)

• restoration failure

  material fraction

  2 years

Secondary Outcomes (1)

• marginal staining

  2 years

Study Arms (2)

Incremental filling technique

ACTIVE COMPARATOR

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

Procedure: Direct composite resin

Bulk Fill

EXPERIMENTAL

Bulk fill composite resin filling all the cavity

Procedure: Direct composite resin

Interventions

Direct composite resin 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; Incremental filling technique

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renata Afonso da Silva Pereira: lead
• Coordination for the Improvement of Higher Education Personnel: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Universidade Federal de Uberlândia

Uberlândia, Minas Gerias, 38405320, Brazil

Location

Study Officials

• Carlos J Soares, DDS,MS,PHD

  Universidade Federal de Uberlândia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PHD student

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 3, 2019
• Study Start: January 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: May 6, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)