Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT (NCT07576673) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Self-Cure vs. Highly Filled Flowable Composite in Carious Cervical Lesions: 18-Month RCT
Egypt50 participantsStarted 2026-09
Plain-language summary
The aim of the study is to compare and evaluate the clinical performance of a self cure composite system versus a highly filled flowable composite in the restoration of carious cervical lesions over an 18 months follow up period.
Who can participate
Age range
21 Years – 45 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.
Patient-related Criteria:
A) Inclusion Criteria:
* Patients consulting in the outpatient clinic with cervical carious lesion.
* Age between 21-45 years.
* Males and females.
B) Exclusion Criteria:
* Systemic disease or severe medical complication.
* Allergy to any of the restorative materials.
* Pregnancy.
* Disabilities.
* Heavy smoking; xerostomia.
* Lack of compliance.
* Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits.
Tooth-related Criteria:
A) Inclusion Criteria:
* Small to moderate class V carious lesion.
* Teeth are vital with no signs of irreversible pulpitis.
* Caries cervical margins above the CEJ.
* Well-formed and fully erupted in normal functional occlusion with natural antagonist.
B) Exclusion Criteria:
* Deciduous teeth; as the study is targeting only permanent teeth.
* Deep carious defects (close to the pulp, less than 1 mm distance).
* Tooth hypersensitivity.
* Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
* Heavy occlusion and occlusal contacts or history of bruxism.
* Endodontically treated teeth.
* Periapical pathology or signs of pulpal pathology.
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.