Clinical Performance of Three Different Restorative Materials
April 27, 2026 updated by: Dr. Fatma Dilşad Öz, Hacettepe University
Clinical Performance of Three Different Restorative Materials-Nanohybrid, Bulk-fill, and Alkasite-based
The clinical performance of a bioactive composite (alkasite-based), a nanohybrid resin composite and a bulk-fill resin composite in class II restorations will be evaluated and compared.
After recruiting participants with at least 3 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 three groups: a bioactive composite [Cention Forte Ivoclar Vivadent, Schaan, Liechtenstein], a nanohybrid resin composite [Tetric N-Ceram2 (Ivoclar Vivadent, Schaan, Liechtenstein)] and a bulk-fill resin composite [Tetric N-PowerFill2 (Ivoclar Vivadent, Schaan, Liechtenstein)], 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- age range will be 18 to 65
- patients should have at least 3 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: bioactive composite
Cention Forte Ivoclar Vivadent, Schaan, Liechtenstein
|
bioactive composite restoration
|
|
Experimental: nanohybrid resin composite
Tetric N-Ceram2 (Ivoclar Vivadent, Schaan, Liechtenstein)
|
nanohybrid resin composite restoration
|
|
Experimental: bulk-fill resin composite
Tetric N-PowerFill2 (Ivoclar Vivadent, Schaan, Liechtenstein)
|
bulk-fill resin composite restoration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical performances of different restorative systems according to FDI criteria
Time Frame: two years
|
Two year results according to FDI criteria (scores 1-5, 1-very good, 5-poor/replace)
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 28, 2026
Primary Completion (Estimated)
June 28, 2026
Study Completion (Estimated)
June 28, 2028
Study Registration Dates
First Submitted
April 6, 2026
First Submitted That Met QC Criteria
April 6, 2026
First Posted (Actual)
April 13, 2026
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- bioactive-alkasite
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.