Class V Dental Caries, Type 2 Diabetes MellitusNCT07731308
Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations
A study testing Zirconomer and Beautifil Flow Plus X in people with Class V Dental Caries, Type 2 Diabetes Mellitus and Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer, run by Cairo University.
Trial summary
This randomized controlled clinical trial aims to compare the clinical performance of zirconia-reinforced glass ionomer and injectable giomer restorations in Class V carious lesions among controlled type II diabetic against non-diabetics. Read more about this study
- Who is it for?
- Ages 22 to 55 years
- Conditions the study is for
- Class V Dental Caries, Type 2 Diabetes Mellitus, Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer
- What is being tested?
- Zirconomer and Beautifil Flow Plus X
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2029
- Phase
- Interventional
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 22 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or Female participants from 22 to 55 years
- Controlled diabetic and non-diabetic patients consulting the outpatient clinic
- Patients categorized as moderate or high caries risk
- Patients willing to provide informed consent
- Co-operative patients agreeing to participate in the trial Inclusion Criteria for teeth
- Teeth with class V carious lesion classified according to the International Caries Detection and Assessment System (ICDAS II) as ICDAS code (4) or ICDAS code (5)
- Teeth with normal pulp vitality testing; no signs of inflammation or spontaneous pain before treatment
Who cannot join
- Patients with spontaneous or elicited pain from caries.
- Systemic illnesses other than diabetes.
- Severe bruxism/clenching.
- Temporomandibular joint disorders.
- Inability to return for recall visits/ Refusal to participate in the study.
- Pregnancy.
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- heavy smoking.
- Lack of compliance.
- Teeth presenting with spontaneous or elicited pain
- A lack of normal pulp vitality testing
- Visible or clinical signs of pulpal/periapical inflammation before treatment.
- Class V carious lesions that are not classified as ICDAS code (4) or ICDAS code (5).
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: Clinical Performance of Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations of Diabetic and Non Diabetic Patients: 18 Months Controlled Clinical Trial
This randomized controlled clinical trial aims to compare the clinical performance of zirconia-reinforced glass ionomer and injectable giomer restorations in Class V carious lesions among controlled type II diabetic against non-diabetics. One hundred Class V restorations will be allocated equally into four parallel groups according to restorative material and diabetic status. Clinical performance will be evaluated at baseline, 6, 12, and 18 months using the modified United States Public Health Service (USPHS) criteria. The primary outcome is restoration retention, while secondary outcomes include marginal adaptation, marginal discoloration, secondary caries, and postoperative sensitivity.
- Conditions
- Class V Dental Caries, Type 2 Diabetes Mellitus, Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer
- Being tested
- Zirconomer, Beautifil Flow Plus X
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZirconomerOther
Zirconia-reinforced glass ionomer restorative material (SHOFU)
Beautifil Flow Plus XOther
Injectable giomer restorative material incorporating S-PRG technology (SHOFU)
| Study group | Role | What they receive |
|---|---|---|
| Diabetic | Experimental | Not described Receives: Other: Zirconomer; Other: Beautifil Flow Plus X |
| Non-diabetic | Experimental | Not described Receives: Other: Zirconomer; Other: Beautifil Flow Plus X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration Retention
Restoration retention assessed using the modified USPHS criteria
Measured: Baseline, 6 months, 12 months, and 18 months
Secondary outcomes (4)
Marginal adaptation
Using Modified USPHS Criteria
Measured: Baseline, 6 months, 12 months, and 18 months
Marginal discoloration
Using Modified USPHS Criteria
Measured: Baseline, 6 months, 12 months and 18 months
Secondary caries
Using Modified USPHS Criteria
Measured: Baseline, 6 months, 12 months and 18 months.
Postoperative sensitivity
Using Modified USPHS Criteria
Measured: Baseline, 6 months, 12 months and 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class V Dental Caries, Type 2 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ayman Hamdy Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731308
- Sponsor's protocol ID
- Cons 3-7-5
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No