Bioactive Restorative Materials for Class II Restorations (BIO-CLASS II)
April 20, 2026 updated by: Ekin Dermanlı, Hacettepe University
Evaluation of Bioactive Dental Restorative Materials in Class II Restorations: A Controlled Randomized Split-Mouth Study
This randomized split-mouth clinical trial aims to evaluate the clinical performance of bioactive restorative materials used in Class II restorations in permanent posterior teeth.
The study compares a giomer-based bulk-fill restorative material, a giomer restorative material, and a resin-modified glass ionomer cement in terms of clinical success and overall clinical performance.
Patients requiring at least three Class II restorations in posterior teeth are treated under standardized clinical conditions.
Clinical evaluations are performed at baseline and follow-up visits to assess short- and long-term outcomes.
Study Overview
Status
Active, not recruiting
Detailed Description
This is a single-center, randomized, controlled split-mouth clinical trial conducted at Hacettepe University Faculty of Dentistry. The aim of the study is to compare the clinical performance of bioactive restorative materials used in Class II posterior restorations.
Eligible patients requiring at least three Class II restorations in permanent posterior teeth are included in the study. Each patient receives restorations with different bioactive restorative materials in separate treatment sites according to a split-mouth design. The tested materials include a giomer-based bulk-fill restorative material, a giomer restorative material, and a resin-modified glass ionomer cement. Randomization is used to assign the restorative materials to the treatment sites.
All restorative procedures are performed under standardized clinical protocols. Clinical performance is evaluated using modified FDI criteria.
Follow-up evaluations are planned at 6, 12, and 24 months after treatment. The 6-month results are used for interim analysis, while long-term follow-up will assess the durability and clinical success of the restorative materials.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ankara, Turkey (Türkiye), 06230
- Hacettepe University Faculty of Dentistry, Department of Restorative Dentistry
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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
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy individuals without any systemic disease that could contraindicate restorative treatment
- Individuals aged between 18 and 50 years
- Individuals who agreed to participate in the study and signed the informed consent form
- Individuals with at least three proximal carious lesions in premolar or molar teeth, classified as D2 (lesions extending to the middle third of dentin) or D3 (lesions extending to the inner third of dentin) according to the ICDAS classification
- Teeth with intact enamel and dentin structure that had not been previously restored
- Individuals who brushed their teeth at least twice a day
- Individuals without physical disabilities that could prevent attendance at follow-up visits
- Individuals with at least 20 teeth in occlusion and with antagonist teeth in the opposing arch
- Vital teeth without signs of periapical pathology
- Periodontally healthy teeth that were not used as abutments for any prosthetic restoration
- Teeth without displacement or mobility
- Individuals who had undergone initial periodontal therapy
Exclusion Criteria:
- Pregnant or breastfeeding individuals
- Individuals with advanced periodontal disease
- Individuals using removable partial dentures
- Individuals with bruxism
- Individuals with severe malocclusion
- Individuals with known allergies to resin-based restorative materials or adhesive agents
- Individuals with a history of allergy to local anesthetics or their administration
- Individuals with latex allergy
- Individuals with poor oral hygiene
- Teeth that had been previously restored or were undergoing orthodontic treatment
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: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Giomer Restorative Material
Class II posterior restorations restored with a giomer restorative material under standardized clinical conditions.
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Class II posterior restorations restored with a giomer restorative material according to the manufacturer's instructions under standardized clinical conditions.
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Experimental: Giomer-Based Bulk-Fill Restorative Material
Class II posterior restorations restored with a giomer-based bulk-fill restorative material under standardized clinical conditions.
|
Class II posterior restorations restored with a giomer-based bulk-fill restorative material according to the manufacturer's instructions under standardized clinical conditions.
|
|
Experimental: Resin-Modified Glass Ionomer Cement
Class II posterior restorations restored with a resin-modified glass ionomer cement under standardized clinical conditions.
|
Class II posterior restorations restored with a resin-modified glass ionomer cement according to the manufacturer's instructions under standardized clinical conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention and fracture of restorations
Time Frame: 6 Months after restoration placement"
|
Retention and fracture of Class II restorations will be evaluated using modified FDI World Dental Federation criteria by a single examiner.
Restorations will be scored based on the presence of loss of retention, fracture, or chipping.
A score of 1 (excellent) or 2 (good) will be considered clinically successful.
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6 Months after restoration placement"
|
|
Marginal adaptation of restorations
Time Frame: 6 Months after restoration placement"
|
Marginal adaptation will be assessed using modified FDI criteria by a single examiner.
The presence of marginal gaps or discrepancies will be evaluated using visual inspection.
|
6 Months after restoration placement"
|
|
Surface luster of restorations
Time Frame: 6 Months after restoration placement"
|
Surface luster will be assessed using modified FDI criteria by a single examiner.
The surface gloss and texture of restorations will be evaluated.
|
6 Months after restoration placement"
|
|
Postoperative sensitivity
Time Frame: 6 Months after restoration placement"
|
Postoperative sensitivity will be assessed using modified FDI criteria by a single examiner.
Sensitivity will be evaluated based on clinical examination and patient-reported symptoms.
|
6 Months after restoration placement"
|
|
Secondary caries
Time Frame: 6 Months after restoration placement"
|
Secondary caries will be evaluated using clinical and radiographic examination according to modified FDI World Dental Federation criteria by a single examiner.
Radiographic evaluation will be used to detect recurrent caries and any pathological findings adjacent to the restorations.
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6 Months after restoration placement"
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Restoration survival
Time Frame: 12 and 24 months after restoration placement
|
Restoration survival will be evaluated at 12 and 24 months based on the presence of restorations in function without the need for repair or replacement.
Failures will include restoration loss, fracture requiring replacement, or the presence of secondary caries leading to restoration replacement.
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12 and 24 months after restoration placement
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Elif Öztürk, PhD, Hacettepe University Faculty of Dentistry, Department of Restorative Dentistry
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 (Actual)
February 14, 2025
Primary Completion (Actual)
March 3, 2026
Study Completion (Estimated)
September 3, 2027
Study Registration Dates
First Submitted
April 10, 2026
First Submitted That Met QC Criteria
April 20, 2026
First Posted (Actual)
April 27, 2026
Study Record Updates
Last Update Posted (Actual)
April 27, 2026
Last Update Submitted That Met QC Criteria
April 20, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KA-24028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Individual participant data sharing plans have not yet been determined.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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