Dental CariesION-REST IINCT07688343
Clinical Performance of Different Ion-Releasing Restorative Systems in Class II Cavities
A study testing conventional bulk fill restorative system, ion-releasing restorative system 1 and ion-releasing restorative system 2 in people with Dental Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
Different ion-releasing restorative systems will be applied in class II cavities then their clinical performance will be evaluated and compared Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- conventional bulk fill restorative system, ion-releasing restorative system 1 and ion-releasing restorative system 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Jul 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 4 carious posterior teeth
Who cannot join
- pregnancy - not able to attend for regular follow-up -smokers or very bad oral hygiene
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Two-Year Clinical Performance of Different Ion-Releasing Restorative Systems Applied in Class II Cavities
Different ion-releasing restorative systems will be applied in class II cavities then their clinical performance will be evaluated and compared
Read the detailed description
This randomized clinical trial aims to evaluate the clinical performance of different ion-releasing restorative systems used in Class II posterior cavities over a two-year follow-up. Patients must be in adults (not less than 18 years old), able to attend regular follow-up visits, presenting with at least four carious class II posterior teeth requiring restoration. Pregnant patients will be excluded.
- Conditions
- Dental Caries
- Being tested
- conventional bulk fill restorative system, ion-releasing restorative system 1, ion-releasing restorative system 2, ion-releasing restorative system 3
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional bulk fill restorative systemProcedure or surgery
conventional bulk fill restorative system used for posterior applications
ion-releasing restorative system 1Procedure or surgery
ion-releasing restorative system 1 used for posterior applications
ion-releasing restorative system 2Procedure or surgery
ion-releasing restorative system 2 used for posterior applications
ion-releasing restorative system 3Procedure or surgery
ion-releasing restorative system 3 used for posterior applications
| Study group | Role | What they receive |
|---|---|---|
| conventional bulk fill restorative system | Experimental | posterior cavities restored with conventional bulk fill restorative system applied in single increment according to the manufacturer's instructions Receives: Procedure: conventional bulk fill restorative system |
| ion- releasing restorative system 1 | Experimental | posterior cavities restored with ion-releasing restorative system applied 1 in single increment according to the manufacturer's instructions Receives: Procedure: ion-releasing restorative system 1 |
| ion-releasing restorative system 2 | Experimental | posterior cavities restored with ion-releasing restorative system 2 applied in single increment according to the manufacturer's instructions Receives: Procedure: ion-releasing restorative system 2 |
| ion-releasing restorative system 3 | Experimental | posterior cavities restored with ion-releasing restorative system 3 applied in single increment according to the manufacturer's instructions Receives: Procedure: ion-releasing restorative system 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between baseline and after two years of evaluation
Changes in restoration performance according to the modified Federation Dentaire Internationale (FDI) criteria from baseline to 2 years. Scores range from 1 to 5, where lower scores indicate better clinical performance and higher scores indicate poorer clinical performance.
Measured: baseline to two-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asmaa A Elbanna, Assistant Lecturer, Principal investigator, Faculty of Dentistry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688343
- Sponsor's protocol ID
- MDP.25.04.11
- Acronym
- ION-REST II
- Status last verified
- May 2026
- First submitted
- 30 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol and statistical analysis will be shared to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-Year Clinical Performance of Different Ion-Releasing Restorative Systems Applied in Class II Cavities
- ClinicalTrials.gov ID
- NCT07688343
- Acronym / sponsor ID
- ION-REST II / MDP.25.04.11
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 7 Jul 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.
Different ion-releasing restorative systems will be applied in class II cavities then their clinical performance will be evaluated and compared
Detailed description
This randomized clinical trial aims to evaluate the clinical performance of different ion-releasing restorative systems used in Class II posterior cavities over a two-year follow-up. Patients must be in adults (not less than 18 years old), able to attend regular follow-up visits, presenting with at least four carious class II posterior teeth requiring restoration. Pregnant patients will be excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| conventional bulk fill restorative system | Experimental | Procedure: conventional bulk fill restorative systemposterior cavities restored with conventional bulk fill restorative system applied in single increment according to the manufacturer's instructions |
| ion- releasing restorative system 1 | Experimental | Procedure: ion-releasing restorative system 1posterior cavities restored with ion-releasing restorative system applied 1 in single increment according to the manufacturer's instructions |
| ion-releasing restorative system 2 | Experimental | Procedure: ion-releasing restorative system 2posterior cavities restored with ion-releasing restorative system 2 applied in single increment according to the manufacturer's instructions |
| ion-releasing restorative system 3 | Experimental | Procedure: ion-releasing restorative system 3posterior cavities restored with ion-releasing restorative system 3 applied in single increment according to the manufacturer's instructions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- at least 4 carious posterior teeth
Key exclusion criteria (1 listed)
- pregnancy - not able to attend for regular follow-up -smokers or very bad oral hygiene
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 |
|---|---|---|
| conventional bulk fill restorative systemconventional bulk fill restorative system used for posterior applications | Procedure or surgery | conventional bulk fill restorative system |
| ion-releasing restorative system 1ion-releasing restorative system 1 used for posterior applications | Procedure or surgery | ion- releasing restorative system 1 |
| ion-releasing restorative system 2ion-releasing restorative system 2 used for posterior applications | Procedure or surgery | ion-releasing restorative system 2 |
| ion-releasing restorative system 3ion-releasing restorative system 3 used for posterior applications | Procedure or surgery | ion-releasing restorative system 3 |
Primary outcome
difference between baseline and after two years of evaluation
Time frame: baseline to two-years
Changes in restoration performance according to the modified Federation Dentaire Internationale (FDI) criteria from baseline to 2 years. Scores range from 1 to 5, where lower scores indicate better clinical performance and higher scores indicate poorer clinical performance.
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 9 Jul 2026.
- Individual participant dataSharing planned: Yes. study protocol and statistical analysis will be shared to other researchers
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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.
Asmaa A Elbanna, Assistant Lecturer principal investigator
Faculty of Dentistry, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional bulk fill restorative system, ion-releasing restorative system 1 and ion-releasing restorative system 2 in people with 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 1 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 9 Jul 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?
difference between baseline and after two years of evaluation (time frame: baseline to two-years). 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 9 Jul 2026.