NCT04306549

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 3, 2020

Last Update Submit

March 10, 2020

Conditions

Dental Restoration Failure of Marginal Integrity

Keywords

Clinical studyUSPHS criteriabulk-fillresin compositeClass II

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Bulk-fill resin composite-sonic activated

EXPERIMENTAL

5 mm bulk-filling without capping lightcured 40s

Other: Bulk-Fill and Microhybrid Composite Resins

Bulk-fill resin composite

EXPERIMENTAL

4 mm bulk-filling without capping lightcured 10s

Other: Bulk-Fill and Microhybrid Composite Resins

Microhybrid resin composite

EXPERIMENTAL

2 mm layers, lightcured 20s

Other: Bulk-Fill and Microhybrid Composite Resins

Interventions

Bulk-Fill and Microhybrid Composite ResinsOTHER

Clinical Comparison of Composite Restorations (Two Bulk-Fill and one Microhybrid Composite Resin) to the USPHS Criterias

Also known as: Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
Bulk-fill resin compositeBulk-fill resin composite-sonic activatedMicrohybrid resin composite

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Proffesor

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 13, 2020

Study Start

August 3, 2016

Primary Completion

January 3, 2017

Study Completion

January 4, 2019

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
one year