One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations (NCT06265116) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations
Egypt48 participantsStarted 2024-01-23
Plain-language summary
to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period.
Who can participate
Age range
20 Years – 40 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:
* Patients must present with at least four posterior primary compound proximal caries involving two surfaces, specifically occluso-mesial or occluso-distal cavities, with a corresponding International Caries Detection and Assessment System (ICDAS) score of 4 or 5.
* The buccolingual width of the lesion should be approximately less than two-thirds of the intercuspal distance.
* Teeth to be restored must be in normal occlusion with the natural antagonist teeth.
* Vital teeth with no signs of pulpal inflammation or pathological lesions.
* Normal periodontal status and good oral hygiene.
* Good likelihood of recall availability.
Exclusion Criteria:
* Patients with proximal cavities that extend beyond two surfaces or have a lesion buccolingual width greater than two-thirds of the intercuspal distance, or requiring cusp coverage.
* Partly erupted or endodontic treated teeth.
* Poor oral hygiene or severe periodontitis.
* Absence of neighboring or antagonist teeth.
* Patients with known allergy to any component of the study materials.
* Patients with unstable medical conditions.
* Patients with known unavailability to attend recall visits.
* Pregnant or lactating females.
* Patients with heavy para-functional habits, fractured, or visibly cracked teeth.
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
Percentage of functional and biological properties for each group