Class I Dental CariesNCT07849478
Two-year Clinical Performance of Ion-releasing and Conventional Bulk-fill Resin Composite Restorative Systems.
A study testing self-cure ion-releasing bulk-fill resin composite, ion-releasing bulk-fill resin composite and conventional bulk-fill resin composite in people with Class I Dental Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if ion-releasing composite works to induce remineralization in caries-affected dentin in adults. This study was designed to test the null hypothesis that there was no significant differences in: The two-year clinical performance of ion-releasing and conventional bulk-fill… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Class I Dental Caries
- What is being tested?
- self-cure ion-releasing bulk-fill resin composite, ion-releasing bulk-fill resin composite and conventional bulk-fill resin composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 29 May 2025to May 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female gender. Only cooperative patients are approved to participate in the trial Medically free adult patients. The age range of the patients is 20- 40 years who have at least three Class I carious lesions.
- Patients with normal occluusion
Who cannot join
- Allergic history concerning methacrylates Pregnancy. Heavy smoking; xerostomia. Lack of compliance. Patients with disabilities. Patients who have systemic diseases or severe medically compromised patients. Patients with severe bruxism, clenching, or temporomandibular joint disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ion-Releasing Versus Conventional Bulk-Fill Resin Composite Restorative Systems: Two-year Randomized Clinical Trial and Laboratory Investigations
The goal of this clinical trial is to learn if ion-releasing composite works to induce remineralization in caries-affected dentin in adults.
This study was designed to test the null hypothesis that there was no significant differences in: The two-year clinical performance of ion-releasing and conventional bulk-fill resin composite restorative systems.
Participants:
- received three different restorative systems
- Visit the clinic once every 6 months for checkups and tests
- Conditions
- Class I Dental Caries
- Being tested
- self-cure ion-releasing bulk-fill resin composite, ion-releasing bulk-fill resin composite, conventional bulk-fill resin composite
- Keywords
- ion-releasing, dentin remineralization, class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-cure ion-releasing bulk-fill resin compositeDevice
class I cavity preparation and restoration with self-cure ion-releasing bulk-fill resin composite
ion-releasing bulk-fill resin compositeDevice
class I cavity preparation and restoration with ion-releasing bulk-fill resin composite
conventional bulk-fill resin compositeDevice
class I cavity preparation and restoration with conventional bulk-fill resin composite
| Study group | Role | What they receive |
|---|---|---|
| Group 1: self-cure ion-releasing bulk-fill resin composite | Experimental | Test arm Receives: Device: self-cure ion-releasing bulk-fill resin composite |
| Group 2: ion-releasing bulk-fill resin composite | Experimental | Test arm Receives: Device: ion-releasing bulk-fill resin composite |
| Group 3: conventional bulk-fill resin composite | Experimental | Control arm Receives: Device: conventional bulk-fill resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation scores of Class I restorations according to the revised 2023 FDI criteria
FDI criteria score-Functional (F1 Fracture/Retention; F2 marginal adaptation; F5 Occlusion and wear), biological (B1 caries at restoration margin; B2 dental hard tissue defects at restoration margin; B3 Postoperative hyper-sensitivity), Aesthetic properties (A2 Marginal staining), According to the revised 2023 FDI criteria for,
- Functional properties Restorations will be evaluated for F1 (fracture/retention), F2 (marginal adaptation), and F5 (Occlusion and wear)
- Biological properties Restoration assessment of B1 (caries at restoration margin), B2 (dental hard tissue defects at restoration margin), and B3 Postoperative hyper-sensitivity)
- Aesthetic properties Restorations will be evaluated for A2 (marginal staining)
- Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance.
- Unit of Measure: FDI score
Measured: one week, 6, 12, and 24 months
Secondary outcomes (1)
Clinical evaluation scores of Class I restorations according to the revised 2023 FDI criteria
FDI criteria score-Aesthetic properties (A1) Surface luster and surface texture, Miscellaneous properties (M1) Patient's view, according to the revised 2023 FDI criteria for,
- Aesthetic properties: (A1) Surface luster and surface texture
- Miscellaneous properties: (M1) Patient's view
- Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance.
- Unit of Measure: FDI score
Measured: one week, 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start29 May 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class I Dental CariesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849478
- Sponsor's protocol ID
- MDP.25.4.13
- Status last verified
- May 2026
- First submitted
- 20 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Raghip AGM, Comisi JC, Hamama HH, Mahmoud SH. Two-year randomized clinical trial to evaluate the performance of posterior bulk-fill resin composite with ionic releasing restorative material. J Dent. 2025 Sep;160:105912. doi: 10.1016/j.jdent.2025.105912. Epub 2025 Jun 13.
PubMed 40518039
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ion-Releasing Versus Conventional Bulk-Fill Resin Composite Restorative Systems: Two-year Randomized Clinical Trial and Laboratory Investigations
- ClinicalTrials.gov ID
- NCT07849478
- Acronym / sponsor ID
- MDP.25.4.13
- Conditions
- Class I Dental Caries
- Keywords
- ion-releasing, dentin remineralization, class I
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Sep 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.
The goal of this clinical trial is to learn if ion-releasing composite works to induce remineralization in caries-affected dentin in adults.
This study was designed to test the null hypothesis that there was no significant differences in: The two-year clinical performance of ion-releasing and conventional bulk-fill resin composite restorative systems.
Participants:
- received three different restorative systems
- Visit the clinic once every 6 months for checkups and tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: self-cure ion-releasing bulk-fill resin composite | Experimental | Device: self-cure ion-releasing bulk-fill resin compositeTest arm |
| Group 2: ion-releasing bulk-fill resin composite | Experimental | Device: ion-releasing bulk-fill resin compositeTest arm |
| Group 3: conventional bulk-fill resin composite | Experimental | Device: conventional bulk-fill resin compositeControl arm |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female gender. Only cooperative patients are approved to participate in the trial Medically free adult patients. The age range of the patients is 20- 40 years who have at least three Class I carious lesions.
- Patients with normal occluusion
Key exclusion criteria (1 listed)
- Allergic history concerning methacrylates Pregnancy. Heavy smoking; xerostomia. Lack of compliance. Patients with disabilities. Patients who have systemic diseases or severe medically compromised patients. Patients with severe bruxism, clenching, or temporomandibular joint disorders.
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 |
|---|---|---|
| self-cure ion-releasing bulk-fill resin compositeclass I cavity preparation and restoration with self-cure ion-releasing bulk-fill resin composite | Device | Group 1: self-cure ion-releasing bulk-fill resin composite |
| ion-releasing bulk-fill resin compositeclass I cavity preparation and restoration with ion-releasing bulk-fill resin composite | Device | Group 2: ion-releasing bulk-fill resin composite |
| conventional bulk-fill resin compositeclass I cavity preparation and restoration with conventional bulk-fill resin composite | Device | Group 3: conventional bulk-fill resin composite |
Primary outcome
Clinical evaluation scores of Class I restorations according to the revised 2023 FDI criteria
Time frame: one week, 6, 12, and 24 months
FDI criteria score-Functional (F1 Fracture/Retention; F2 marginal adaptation; F5 Occlusion and wear), biological (B1 caries at restoration margin; B2 dental hard tissue defects at restoration margin; B3 Postoperative hyper-sensitivity), Aesthetic properties (A2 Marginal staining), According to the revised 2023 FDI criteria for, 1. Functional properties Restorations will be evaluated for F1 (fracture/retention), F2 (marginal adaptation), and F5 (Occlusion and wear) 2. Biological properties Restoration assessment of B1 (caries at restoration margin), B2 (dental hard tissue defects at restoration margin), and B3 Postoperative hyper-sensitivity) 3. Aesthetic properties Restorations will be evaluated for A2 (marginal staining) * Mean (SD) scores and the proportion of clinically acceptable restorations (scores 1-3) versus unacceptable restorations (scores 4-5) will be reported. Lower scores indicate better clinical performance. * Unit of Measure: FDI score
1 secondary outcome
Clinical evaluation scores of Class I restorations according to the revised 2023 FDI criteria
Time frame: one week, 6, 12, and 24 months
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 30 Sep 2026.
- Background: PubMed 40518039Raghip AGM, Comisi JC, Hamama HH, Mahmoud SH. Two-year randomized clinical trial to evaluate the performance of posterior bulk-fill resin composite with ionic releasing restorative material. J Dent. 2025 Sep;160:105912. doi: 10.1016/j.jdent.2025.105912. Epub 2025 Jun 13.
- To compare the two-year clinical performance of ion-releasing resin composite with that of a conventional bulk-fill composite in Class I posterior restorations.Link provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-cure ion-releasing bulk-fill resin composite, ion-releasing bulk-fill resin composite and conventional bulk-fill resin composite in people with Class I Dental Caries, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 1 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 30 Sep 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 Egypt. 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?
Clinical evaluation scores of Class I restorations according to the revised 2023 FDI criteria (time frame: one week, 6, 12, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07849478, which also lists 1 linked publication.
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 30 Sep 2026.