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Clinical Trials/NCT04685954
NCT04685954UnknownNot Applicable

Clinical Comparison of Bulk-fill and Incremental Composite Resin Restorations

Hacettepe University1 site in 1 country28 target enrollmentStarted: March 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
28
Locations
1
Primary Endpoint
Clinical performances of different restorative systems according to USPHS criteria

Study Overview

Brief Summary

The clinical performance of a 5-mm bulk-fill and an incremental resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a 5 mm bulk-fill composite resin [Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)] and an incremental posterior composite resin [Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • age range will be 18 to 65
  • patients should have at least 2 approximal caries lesions require restoration
  • healthy periodontal status
  • a good likelihood of recall availability

Exclusion Criteria

  • poor gingival health
  • adverse medical history
  • potential behavioral problems

Outcomes

Primary Outcomes

Clinical performances of different restorative systems according to USPHS criteria

Time Frame: two years

Two year results according to USPHS criteria

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Fatma Dilşad Öz

Assoc. Prof.

Hacettepe University

Study Sites (1)

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