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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04685954
Other study ID # bulk-incremental
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date June 1, 2022

Study information

Verified date December 2020
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 [Filtekā„¢ 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date June 1, 2022
Est. primary completion date June 1, 2018
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:
Filtek Bulk-Fill Posterior
Bulk-fill restorative composite
Filtek Ultimate Universal
Incremental restorative composite

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 USPHS criteria Two year results according to USPHS criteria two years
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