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

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).

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Key information

Conditions

Dental Restoration Failure of Marginal Integrity

Age range

18 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Bulk-Fill and Microhybrid Composite Resins

Other

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

Primary outcomes

Clinical Acceptability

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Collaborators

University of Beykent
Çanakkale Onsekiz Mart University

Registry information

Acronym: Clinical

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2019
First posted: Mar 13, 2020
Registry last updated: Mar 13, 2020

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.

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