Clincosm LogoSign in Get a demo

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

Sponsor
Tokat Gaziosmanpasa University (Other)
Overall Status
Completed
CT.gov ID
NCT04306549
Collaborator
University of Beykent (Other), Çanakkale Onsekiz Mart University (Other)
25
Enrollment
3
Arms
29
Actual Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Bulk-Fill and Microhybrid Composite Resins
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
Actual Study Start Date :
Aug 3, 2016
Actual Primary Completion Date :
Jan 3, 2017
Actual Study Completion Date :
Jan 4, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 22 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tokat Gaziosmanpasa University
    • University of Beykent
    • Çanakkale Onsekiz Mart University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Emine Sirin Karaarslan, Assoc.Proffesor, Tokat Gaziosmanpasa University
    ClinicalTrials.gov Identifier:
    NCT04306549
    Other Study ID Numbers:
    • 2015/36
    First Posted:
    Mar 13, 2020
    Last Update Posted:
    Mar 13, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Emine Sirin Karaarslan, Assoc.Proffesor, Tokat Gaziosmanpasa University
    Clinical study
    USPHS criteria
    bulk-fill
    resin composite
    Class II

    Study Results

    No Results Posted as of Mar 13, 2020