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

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).

Study Overview

• Status: Completed
• Conditions: Dental Restoration Failure of Marginal Integrity
• Intervention / Treatment: Other: Bulk-Fill and Microhybrid Composite Resins

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 22 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bulk-fill resin composite-sonic activated; 5 mm bulk-filling without capping lightcured 40s	Other: Bulk-Fill and Microhybrid Composite Resins; Clinical Comparison of Composite Restorations (Two Bulk-Fill and one Microhybrid Composite Resin) to the USPHS Criterias; Other Names: Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
Experimental: Bulk-fill resin composite; 4 mm bulk-filling without capping lightcured 10s	Other: Bulk-Fill and Microhybrid Composite Resins; Clinical Comparison of Composite Restorations (Two Bulk-Fill and one Microhybrid Composite Resin) to the USPHS Criterias; Other Names: Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
Experimental: Microhybrid resin composite; 2 mm layers, lightcured 20s	Other: Bulk-Fill and Microhybrid Composite Resins; Clinical Comparison of Composite Restorations (Two Bulk-Fill and one Microhybrid Composite Resin) to the USPHS Criterias; Other Names: Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Acceptability	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.	Twenty-Four-Month

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University
• Collaborators: University of Beykent; Çanakkale Onsekiz Mart University

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2016
• Primary Completion (Actual): January 3, 2017
• Study Completion (Actual): January 4, 2019

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: USPHS criteria; Clinical study; bulk-fill; resin composite; Class II
• Other Study ID Numbers: 2015/36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: one year
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No