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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04825379
Other study ID # bioactive-composite
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date September 1, 2024

Study information

Verified date October 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 31
Est. completion date September 1, 2024
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
bioactive composite
Cention N
posterior composite
G-ænial Posterior

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical performances of different restorative systems according to FDI criteria Two year results according to FDI criteria two years
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