Skip to main content
OpenTrials
Completed

NCT Number: NCT03936855

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Composite Resins

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Uberlândia

Uberlândia, Minas Gerias, 38405320, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  • 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

Primary outcomes

  1. restoration failure

    Time frame: 2 years

    material fraction

Secondary outcomes

  1. marginal staining

    Time frame: 2 years

    color alteration in the adhesive interface

Sponsors and collaborators

Lead sponsor

Renata Afonso da Silva Pereira

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordination for the Improvement of Higher Education Personnel
  • Fundação de Amparo à Pesquisa do estado de Minas Gerais

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 3, 2019
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.