Bioactive Dental Restorative MaterialsBIO-CLASS IINCT07552350
Bioactive Restorative Materials for Class II Restorations
A study testing Giomer Restorative Material, Giomer-Based Bulk-Fill Restorative Material and Resin-Modified Glass Ionomer Cement in people with Bioactive Dental Restorative Materials and Class II Dental Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioactive Dental Restorative Materials, Class II Dental Caries
- What is being tested?
- Giomer Restorative Material, Giomer-Based Bulk-Fill Restorative Material and Resin-Modified Glass Ionomer Cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2025to 3 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry, Department of Restorative Dentistry
Ankara, 06230
About this study
Official title: 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.
Read the 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.
- Being tested
- Giomer Restorative Material, Giomer-Based Bulk-Fill Restorative Material, Resin-Modified Glass Ionomer Cement
- Keywords
- Bioactive restorative materials, Class II restoration, Split-mouth trial, Giomer, Resin-modified glass ionomer cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giomer Restorative MaterialDevice
Class II posterior restorations restored with a giomer restorative material according to the manufacturer's instructions under standardized clinical conditions.
Giomer-Based Bulk-Fill Restorative MaterialDevice
Class II posterior restorations restored with a giomer-based bulk-fill restorative material according to the manufacturer's instructions under standardized clinical conditions.
Resin-Modified Glass Ionomer CementDevice
Class II posterior restorations restored with a resin-modified glass ionomer cement according to the manufacturer's instructions under standardized clinical conditions.
| Study group | Role | What they receive |
|---|---|---|
| Giomer Restorative Material | Experimental | Class II posterior restorations restored with a giomer restorative material under standardized clinical conditions. Receives: Device: Giomer Restorative Material |
| Giomer-Based Bulk-Fill Restorative Material | Experimental | Class II posterior restorations restored with a giomer-based bulk-fill restorative material under standardized clinical conditions. Receives: Device: Giomer-Based Bulk-Fill Restorative Material |
| Resin-Modified Glass Ionomer Cement | Experimental | Class II posterior restorations restored with a resin-modified glass ionomer cement under standardized clinical conditions. Receives: Device: Resin-Modified Glass Ionomer Cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention and fracture of restorations
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.
Measured: 6 Months after restoration placement"
Marginal adaptation of restorations
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.
Measured: 6 Months after restoration placement"
Surface luster of restorations
Surface luster will be assessed using modified FDI criteria by a single examiner. The surface gloss and texture of restorations will be evaluated.
Measured: 6 Months after restoration placement"
Postoperative sensitivity
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.
Measured: 6 Months after restoration placement"
Secondary caries
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.
Measured: 6 Months after restoration placement"
Secondary outcomes (1)
Restoration survival
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.
Measured: 12 and 24 months after restoration placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start14 Feb 2025
- Primary completion3 Mar 2026
- Study completion3 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioactive Dental Restorative MaterialsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a split-mouth design in which each participant receives different restorative materials in separate Class II cavities.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin Dermanlı, Hacettepe University
- Investigators
- Elif Öztürk, PhD, Study chair, Hacettepe University Faculty of Dentistry, Department of Restorative Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552350
- Sponsor's protocol ID
- KA-24028
- Acronym
- BIO-CLASS II
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing plans have not yet been determined.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bioactive Dental Restorative Materials in Class II Restorations: A Controlled Randomized Split-Mouth Study
- ClinicalTrials.gov ID
- NCT07552350
- Acronym / sponsor ID
- BIO-CLASS II / KA-24028
- Keywords
- Bioactive restorative materials, Class II restoration, Split-mouth trial, Giomer, Resin-modified glass ionomer cement
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Sep 2027 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This study uses a split-mouth design in which each participant receives different restorative materials in separate Class II cavities.
| Arm | Type | Receives |
|---|---|---|
| Giomer Restorative Material | Experimental | Device: Giomer Restorative MaterialClass II posterior restorations restored with a giomer restorative material under standardized clinical conditions. |
| Giomer-Based Bulk-Fill Restorative Material | Experimental | Device: Giomer-Based Bulk-Fill Restorative MaterialClass II posterior restorations restored with a giomer-based bulk-fill restorative material under standardized clinical conditions. |
| Resin-Modified Glass Ionomer Cement | Experimental | Device: Resin-Modified Glass Ionomer CementClass II posterior restorations restored with a resin-modified glass ionomer cement under standardized clinical conditions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding individuals
- Individuals with advanced periodontal disease
- Individuals using removable partial dentures
- Individuals with bruxism
- Individuals with severe malocclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Giomer Restorative MaterialClass II posterior restorations restored with a giomer restorative material according to the manufacturer's instructions under standardized clinical conditions. | Device | Giomer Restorative Material |
| Giomer-Based Bulk-Fill Restorative MaterialClass II posterior restorations restored with a giomer-based bulk-fill restorative material according to the manufacturer's instructions under standardized clinical conditions. | Device | Giomer-Based Bulk-Fill Restorative Material |
| Resin-Modified Glass Ionomer CementClass II posterior restorations restored with a resin-modified glass ionomer cement according to the manufacturer's instructions under standardized clinical conditions. | Device | Resin-Modified Glass Ionomer Cement |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Restoration survival
Time frame: 12 and 24 months after restoration placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing plans have not yet been determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif Öztürk, PhD study chair
Hacettepe University Faculty of Dentistry, Department of Restorative Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Giomer Restorative Material, Giomer-Based Bulk-Fill Restorative Material and Resin-Modified Glass Ionomer Cement in people with Bioactive Dental Restorative Materials and Class II Dental Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention and fracture of restorations (time frame: 6 Months after restoration placement"). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.