Clinical Performance of Two HEMA-Free Universal Adhesive Systems (NCT07731061) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Performance of Two HEMA-Free Universal Adhesive Systems
50 participantsStarted 2026-11
Plain-language summary
This randomized controlled clinical trial aims to compare the 12-month clinical performance of two HEMA-free universal adhesive systems for restoring anterior cervical carious lesions. Participants will be randomly allocated (1:1) to receive restorations using either a two-bottle HEMA-free universal adhesive (G2-Bond Universal) or a one-bottle HEMA-free universal adhesive (BeautiBond Xtreme), both applied in self-etch mode. The primary outcome is restoration retention, while secondary outcomes include marginal adaptation, marginal discoloration, and postoperative sensitivity, evaluated at baseline (24 hours), 6 months, and 12 months using the modified USPHS criteria.
Who can participate
Age range
18 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:
. Patients aged from 18 to 55 years.
* Patients with cervical carious lesions on the labial surfaces of anterior teeth.
* Lesions classified as ICDAS 3 and 4.
* Patients with good general health.
* Patients able and willing to attend the follow-up visits at baseline, 6 months and 12 months.
Exclusion Criteria:
* Patients with severe or chronic periodontal disease.
* Patients with poor oral hygiene or uncontrolled plaque accumulation.
* Patients with bruxism or other parafunctional habits that may affect restoration survival.
* Non-vital teeth.
* Fractured or cracked teeth.
* Teeth with defective existing cervical restorations.
* Root caries extending beyond the restorative indication of the study.
* Pregnant or lactating patients.
* Patients with known allergy or hypersensitivity to any component of the adhesive systems or restorative material used in the study.
* Patients unable to attend the scheduled follow-up visits.
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.