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
Device: bioactive composite
bioactive composite restoration
Experimental: nanohybrid resin composite
Tetric N-Ceram2 (Ivoclar Vivadent, Schaan, Liechtenstein)
Device: nanohybrid resin composite
nanohybrid resin composite restoration
Experimental: bulk-fill resin composite
Tetric N-PowerFill2 (Ivoclar Vivadent, Schaan, Liechtenstein)
Device: bulk-fill resin composite
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

Hacettepe University

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.

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