Clinical trial NCT03936855: Clinical Evaluation of Posterior Direct Restoration in Adolescents
Official title: Clinical Evaluation of Posterior Direct Restoration in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Composite Resins
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
Collaborators: name: Coordination for the Improvement of Higher Education Personnel
name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-05-03
Enrollment: 54
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: restoration failure
timeFrame: 2 years
Secondary outcomes:
measure: marginal staining
timeFrame: 2 years
Other outcomes:
Locations:
city: Uberlândia
country: Brazil
facility: Universidade Federal de Uberlândia
state: Minas Gerias
Study officials:
affiliation: Universidade Federal de Uberlândia
name: Carlos J Soares, DDS,MS,PHD
role: STUDY_CHAIR
References: