Diabetes Mellitus (DM)NCT07432724
This Study is Conducted to Evaluate the 18-month Clinical Performance of Complete Bioactive Restorative System for Occlusal Restorations Between Diabetic and Non-diabetic Patients.
A study testing bioactive composite in people with Diabetes Mellitus (DM), run by Cairo University.
Trial summary
This study is conducted to evaluate the 18-month clinical performance of complete bioactive restorative system for occlusal restorations between diabetic and non-diabetic patients. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus (DM)
- What is being tested?
- bioactive composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Apr 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients indicated for a Class I posterior composite restoration
- permanent tooth
- ICDAS 3 or 4
Who cannot join
- uncontrolled diabetic patients
- primary dentition
- special needs
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Clinical Evaluation of Bioactive Restorative System in Controlled Diabetic and Non Diabetic Patients: An 18-Month Non-Randomized Comparative Study.
This study is conducted to evaluate the 18-month clinical performance of complete bioactive restorative system for occlusal restorations between diabetic and non-diabetic patients.
- Conditions
- Diabetes Mellitus (DM)
- Being tested
- bioactive composite
- Keywords
- Bioactive composite
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioactive compositeOther
the bioactive component present in the composite restoration.
| Study group | Role | What they receive |
|---|---|---|
| diabetic patients | Experimental | Not described Receives: Other: bioactive composite |
| Non diabetic patients | Experimental | Not described Receives: Other: bioactive composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal discoloration
Measuring device: Modified USPHS criteria
Measured: T0: Baseline T1: 6 months T2: 12 months T3: 18 month
Secondary outcomes (1)
Marginal adaptation, color match, secondary caries, Retention, wear, and postoperative sensitivity.
measuring device: Modified USPHS criteria
Measured: T0: baseline T1: 6 months T2: 12 months T3: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus (DM)Studies of the same condition, open and under way.
- More trials run by Cairo 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Hassan, Cairo University
- Investigators
- Rania Mosallam, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432724
- Sponsor's protocol ID
- 09061992
- Status last verified
- Jan 2026
- First submitted
- 18 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Evaluation of Bioactive Restorative System in Controlled Diabetic and Non Diabetic Patients: An 18-Month Non-Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT07432724
- Acronym / sponsor ID
- 09061992
- Conditions
- Diabetes Mellitus (DM)
- Keywords
- Bioactive composite
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 25 Feb 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 study is conducted to evaluate the 18-month clinical performance of complete bioactive restorative system for occlusal restorations between diabetic and non-diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic patients | Experimental | Other: bioactive composite |
| Non diabetic patients | Experimental | Other: bioactive composite |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients indicated for a Class I posterior composite restoration
- permanent tooth
- ICDAS 3 or 4
Key exclusion criteria (3 listed)
- uncontrolled diabetic patients
- primary dentition
- special needs
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 |
|---|---|---|
| bioactive compositethe bioactive component present in the composite restoration. | Other | Non diabetic patients, diabetic patients |
Primary outcome
Marginal discoloration
Time frame: T0: Baseline T1: 6 months T2: 12 months T3: 18 month
Measuring device: Modified USPHS criteria
1 secondary outcome
Marginal adaptation, color match, secondary caries, Retention, wear, and postoperative sensitivity.
Time frame: T0: baseline T1: 6 months T2: 12 months T3: 18 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 25 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
Rania Mosallam, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing bioactive composite in people with Diabetes Mellitus (DM), run by Cairo University.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Sara Mohamed Manaa, PhD (00201022484815 ext. 002, sara.mohamed.manaa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal discoloration (time frame: T0: Baseline T1: 6 months T2: 12 months T3: 18 month). 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 25 Feb 2026.