Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations

Not Applicable

Completed

• Conditions: Dental Restoration Failure of Marginal Integrity
• Interventions: Other: Bulk-Fill and Microhybrid Composite Resins

• Registration Number: NCT04306549
• Lead Sponsor: Tokat Gaziosmanpasa University

Brief Summary

ABSTRACT Objective The aim of this study was to evaluate the clinical performance of one microhybrid and two bulk-fill resin composites in Class II cavities for up to two years.

Materials and methods In total, 75 Class II restorations were made in 25 patients, using three restorative materials: two nanohybrid bulk-fill resin composites, Sonic Fill (SF) and x-tra fil (XF), and a microhybrid composite, Filtek Z-250 (FZ). The restorations were blindly evaluated by two examiners at baseline and at 6, 12, and 24 months, using U.S. Public Health Service (USPHS) criteria. The restoration groups for each category were compared using the Pearson chi-square test, and the Cochran Q-test was used to compare the changes across different time points within each restorative material (p \<0.05).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-03
• Primary Completion: 2017-01-03
• Study Completion: 2019-01-04
• Status Verified: 2020-03
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-13
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patient in need of restoration of caries lesion (diagnosed with bitewing radiograph and clinical examination);
• teeth in need of restoration to be first or second molars or permanent premolars;
• at least three Class II restorations required in each patient and the number of restorations of each material to be equal in each patient;
• the antagonist and adjacent tooth in contact;
• pulp vitalized and free of painful symptoms; teeth involved not to have undergone direct pulp capping;
• no history of hypersensitivity in the teeth to be restored;
• permanent dentition;
• good oral health and absence of periodontal disease;
• patients not to have suffered from systemic diseases or allergies;
• absence of deleterious habits, xerostomia, and bruxism.

Exclusion Criteria

• Fewer than 20 teeth;
• history of existing tooth sensitivity;
• known allergy to resin-based materials or any of the other materials used in this study;
• pregnancy or breastfeeding;
• chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs;
• non-vital teeth;
• abutment teeth for fixed or removable prostheses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bulk-fill resin composite-sonic activated	Bulk-Fill and Microhybrid Composite Resins	5 mm bulk-filling without capping lightcured 40s
Microhybrid resin composite	Bulk-Fill and Microhybrid Composite Resins	2 mm layers, lightcured 20s
Bulk-fill resin composite	Bulk-Fill and Microhybrid Composite Resins	4 mm bulk-filling without capping lightcured 10s

Primary Outcome Measures

Name	Time	Method
Clinical Acceptability	Twenty-Four-Month	One week after restoration placement (baseline), patients were recalled and restorations were examined clinically. Direct clinical evaluation of restorations was performed using the USPHS criteria by two independent investigators using mirrors, probes, and bitewing radiographs and scored as Alpha, Bravo, or Charlie. Alpha corresponded to excellent, Bravo to clinically acceptable, and Charlie to clinically unacceptable results. Patients were recalled at 6, 12, and 24 months for assessments of the restorations, using the same criteria as at baseline. At each recall, the same two calibrated evaluators, who were blinded to the restoratives used for cavities and patients, examined the restorations. To ensure a double-blind study, the evaluators were not informed about which filling material had been used on which teeth.