Diabetes MellitusNCT07407855
Clinical Performance of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic and Non-Diabetic Patients
A study testing Giomer-based composite restoration in people with Diabetes Mellitus, run by Cairo University.
Trial summary
Diabetes mellitus is associated with structural and biochemical alterations in dentin that may negatively affect the clinical performance and longevity of adhesive dental restorations, particularly in cervical carious lesions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Giomer-based composite restoration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Aug 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with Class V carious lesions (ICDAS scores 3 or 4).
- Controlled diabetic patients diagnosed with diabetes mellitus (for diabetic group).
- Non-diabetic patients with no systemic diseases (for control group).
- Teeth indicated for Class V composite restoration.
Who cannot join
- Uncontrolled diabetes mellitus.
- Patients with other systemic diseases affecting oral health.
- Teeth with pulpal involvement or requiring endodontic treatment.
- Patients with parafunctional habits. Pregnant or lactating women
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: Comparative Evaluation of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic Versus Non-Diabetic Patients Using Modified USPHS Criteria: An 18-Month Non-Randomized Clinical Trial
Diabetes mellitus is associated with structural and biochemical alterations in dentin that may negatively affect the clinical performance and longevity of adhesive dental restorations, particularly in cervical carious lesions. Giomer-based composite resins, containing pre-reacted glass ionomer fillers, release fluoride and other beneficial ions that may enhance remineralization and reduce the risk of secondary caries.
This prospective, parallel-group, non-randomized clinical trial aims to evaluate the clinical performance of Giomer-based composite restorations in Class V carious lesions in controlled diabetic and non-diabetic patients. Restorations will be assessed using Modified USPHS criteria at baseline, 6, 12, and 18 months, with retention as the primary outcome and marginal adaptation, secondary caries, marginal discoloration, and post-operative sensitivity as secondary outcomes.
- Conditions
- Diabetes Mellitus
- Being tested
- Giomer-based composite restoration
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giomer-based composite restorationDevice
Giomer-based composite restoration (Beautifil® II LS, SHOFU, USA) using universal adhesive (BeautiBond® Xtreme, SHOFU, USA).
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Patients | Experimental | Controlled diabetic patients with Class V carious lesions restored using Giomer-based composite resin Receives: Device: Giomer-based composite restoration |
| Non-Diabetic Patients | Active comparator | Non-diabetic patients with Class V carious lesions restored using the same Giomer-based composite and adhesive protocol. Receives: Device: Giomer-based composite restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration Retention Score Assessed Using Modified USPHS Criteria
Retention of Class V Giomer-based composite restorations will be evaluated using Modified United States Public Health Service (USPHS) criteria. Each restoration will be assigned an ordinal score (Alpha, Bravo, Charlie) based on the presence or loss of restoration. Data will be reported as distribution of USPHS scores and frequency of restoration loss over time.
Measured: Baseline, 6 months, 12 months, and 18 months
Secondary outcomes (4)
Marginal Adaptation Score Assessed Using Modified USPHS Criteria
Marginal integrity between tooth and restoration will be evaluated using Modified USPHS criteria. Each restoration will receive an ordinal score (Alpha, Bravo, Charlie) at each follow-up visit.
Measured: Baseline, 6 months, 12 months, and 18 months
Secondary Caries Score Assessed Using Modified USPHS Criteria
Presence of recurrent caries adjacent to the restoration will be assessed using Modified USPHS criteria and recorded as ordinal categorical scores (Alpha, Bravo, Charlie).
Measured: Baseline, 6 months, 12 months, 18 months
Marginal Discoloration Score Assessed Using Modified USPHS Criteria
Discoloration at the tooth-restoration margin will be evaluated using Modified USPHS criteria and recorded as ordinal categorical scores.
Measured: Baseline, 6 months, 12 months, 18 months
Post-Operative Sensitivity Score Assessed Using Modified USPHS Criteria
Tooth sensitivity associated with restored teeth will be clinically evaluated and scored using Modified USPHS criteria ordinal scores.
Measured: Baseline, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study startAug 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Wael Maher, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407855
- Sponsor's protocol ID
- CU-FD-CD-4-1-3-2025
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic Versus Non-Diabetic Patients Using Modified USPHS Criteria: An 18-Month Non-Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07407855
- Acronym / sponsor ID
- CU-FD-CD-4-1-3-2025
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 12 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.
Diabetes mellitus is associated with structural and biochemical alterations in dentin that may negatively affect the clinical performance and longevity of adhesive dental restorations, particularly in cervical carious lesions. Giomer-based composite resins, containing pre-reacted glass ionomer fillers, release fluoride and other beneficial ions that may enhance remineralization and reduce the risk of secondary caries.
This prospective, parallel-group, non-randomized clinical trial aims to evaluate the clinical performance of Giomer-based composite restorations in Class V carious lesions in controlled diabetic and non-diabetic patients. Restorations will be assessed using Modified USPHS criteria at baseline, 6, 12, and 18 months, with retention as the primary outcome and marginal adaptation, secondary caries, marginal discoloration, and post-operative sensitivity as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Patients | Experimental | Device: Giomer-based composite restorationControlled diabetic patients with Class V carious lesions restored using Giomer-based composite resin |
| Non-Diabetic Patients | Active comparator | Device: Giomer-based composite restorationNon-diabetic patients with Class V carious lesions restored using the same Giomer-based composite and adhesive protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with Class V carious lesions (ICDAS scores 3 or 4).
- Controlled diabetic patients diagnosed with diabetes mellitus (for diabetic group).
- Non-diabetic patients with no systemic diseases (for control group).
- Teeth indicated for Class V composite restoration.
Key exclusion criteria (4 listed)
- Uncontrolled diabetes mellitus.
- Patients with other systemic diseases affecting oral health.
- Teeth with pulpal involvement or requiring endodontic treatment.
- Patients with parafunctional habits. Pregnant or lactating women
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-based composite restorationGiomer-based composite restoration (Beautifil® II LS, SHOFU, USA) using universal adhesive (BeautiBond® Xtreme, SHOFU, USA). | Device | Diabetic Patients, Non-Diabetic Patients |
Primary outcome
Restoration Retention Score Assessed Using Modified USPHS Criteria
Time frame: Baseline, 6 months, 12 months, and 18 months
Retention of Class V Giomer-based composite restorations will be evaluated using Modified United States Public Health Service (USPHS) criteria. Each restoration will be assigned an ordinal score (Alpha, Bravo, Charlie) based on the presence or loss of restoration. Data will be reported as distribution of USPHS scores and frequency of restoration loss over time.
4 secondary outcomes
Marginal Adaptation Score Assessed Using Modified USPHS Criteria
Time frame: Baseline, 6 months, 12 months, and 18 months
Secondary Caries Score Assessed Using Modified USPHS Criteria
Time frame: Baseline, 6 months, 12 months, 18 months
Marginal Discoloration Score Assessed Using Modified USPHS Criteria
Time frame: Baseline, 6 months, 12 months, 18 months
Post-Operative Sensitivity Score Assessed Using Modified USPHS Criteria
Time frame: Baseline, 6 months, 12 months, 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 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
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.
Questions about this trial
What is this clinical trial studying?
A study testing Giomer-based composite restoration in people with Diabetes Mellitus, 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 4 inclusion and 4 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 12 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 Radwa Wael Ellahouny (01274268817, radwa.wael@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration Retention Score Assessed Using Modified USPHS Criteria (time frame: Baseline, 6 months, 12 months, and 18 months). 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 12 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.