The Study Aims to Compare the Effectiveness of Mesoporous Bioactive Glass-containing Adhesives vs… (NCT06990945) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Study Aims to Compare the Effectiveness of Mesoporous Bioactive Glass-containing Adhesives vs Conventional Universal Adhesives on the Clinical Performance Composite Restorations Through Promoting Dentin Remineralization After Selective Caries Removal Over a Two-year Follow-up
Egypt80 participantsStarted 2025-10
Plain-language summary
a two-year, double-blind, randomized controlled trial evaluates the effectiveness of a bioactive glass adhesive (Hi-Bond Universal) versus a conventional adhesive (OptiBond Universal) in Class II carious lesions. The study will assess clinical outcomes such as fracture resistance and marginal adaptation and radiographic evidence of dentin remineralization in 80 adult participants. Hypersensitivity and secondary caries development will also be monitored at multiple time points to determine comparative efficacy.
Who can participate
Age range
22 Years – 42 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:
* Adult patients aged 22 to 42 years.
Presence of Class II carious lesions in posterior permanent teeth (ICDAS 5 \& 6).
Radiographic evidence of caries extending to 50% of dentin with a radiopaque layer between the lesion and pulp chamber.
Teeth with normal pulp vitality confirmed through cold pulp sensibility test.
Teeth with no periapical pathosis on radiographic examination.
Good oral hygiene as determined by the attending clinician.
Willingness to sign the informed consent and comply with the 2-year follow-up protocol.
Cooperative patients who can attend all follow-up visits.
Exclusion Criteria:
* Allergy to any of the restorative materials (OptiBond Universal or Hi-Bond Universal).
Patients currently undergoing orthodontic treatment with fixed appliances.
Pregnant women or those planning pregnancy during the study period.
Patients with systemic diseases that could interfere with dental treatment (e.g., uncontrolled diabetes, cardiovascular diseases).
Use of analgesics or medications that could mask postoperative sensitivity.
Teeth with previous restorations or treatment in the target area.
Teeth exhibiting spontaneous pain or lingering pain after sensitivity testing, indicating irreversible pulpitis.
Negative response in cold pulp sensibility test, indicating pulp necrosis.
Teeth with periapical radiolucencies or signs of infection.
Mobile teeth due to periodontal disease or trauma.
Teeth with extensive structural damage, such as c…
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.