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Clinical Trials/NCT04825379
NCT04825379
Active, not recruiting
Not Applicable

Clinical Evaluation of a Bioactive Material

Hacettepe University1 site in 1 country31 target enrollmentJune 1, 2021
ConditionsTooth Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tooth Disease
Sponsor
Hacettepe University
Enrollment
31
Locations
1
Primary Endpoint
Clinical performances of different restorative systems according to FDI criteria
Status
Active, not recruiting
Last Updated
4 months ago

Overview

Brief Summary

The clinical performance of a bioactive composite and a posterior 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 bioactive composite [Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)] and a posterior resin composite [G-ænial Posterior (GC, Tokyo, Japan) (GP)] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
September 1, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Fatma Dilşad Öz

Assoc. Prof. Dr.

Hacettepe University

Eligibility Criteria

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 FDI criteria

Time Frame: two years

Two year results according to FDI criteria

Study Sites (1)

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