Clinical Evaluation of Posterior Direct Restoration in Adolescents

Composite Resins Clinical Trial

Official title:

Clinical Evaluation of Posterior Direct Restoration in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03936855
• Other study ID #: UFU001
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 2018

Study information

• Verified date: May 2019
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Composite Resins

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal de Uberlândia	Uberlândia	Minas Gerias

Sponsors (4)

Lead Sponsor	Collaborator
Renata Afonso da Silva Pereira	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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	restoration failure	material fraction	2 years
Secondary	marginal staining	color alteration in the adhesive interface	2 years