Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations (NCT07731308) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations
100 participantsStarted 2027-01
Plain-language 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. 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.
Who can participate
Age range
22 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* heavy smoking.
* Lack of compliance.
Exclusion criteria for teeth
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Restoration Retention
Timeframe: Baseline, 6 months, 12 months, and 18 months