Evaluation of a New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in… (NCT05149209) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of a New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions
Egypt30 participantsStarted 2021-12-15
Plain-language summary
* This study will be conducted to evaluate and compare the clinical performance of fluoride, calcium, and phosphate-releasing new bioactive material versus a fluoride-releasing hybrid restorative material in cervical lesions for one-year follow-up.
* The clinical evaluation will be done using modified USPHS criteria at baseline,3,6,9 and 12 months.
Who can participate
Age range
18 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:
* a)Inclusion Criteria of participants:
* Male or female gender.
* Only co-operative patients will be approved to participate in the trial.
* Medically free adult patients.
* The age range of the patients is 18-40 years. b)Inclusion Criteria of teeth:
* Small to moderate cervical lesion.
* Vital upper or lower teeth with no signs of irreversible pulpitis.
* Caries extension shouldn't exceed mesiodistal width and inciso(occluso)-gingival length not exceed incisal (occlusal) one third.
Exclusion Criteria:
* a)Exclusion criteria of participants:
* Allergic history concerning methacrylates
* Pregnancy
* Heavy smoking; xerostomia
* Lack of compliance
* Patients with disabilities.
* Patients having systemic diseases or severe medically compromised.
* Patients with severe bruxism, clenching, or temporomandibular joint disorders.
b)Exclusion criteria of the teeth:
* Deep defects (close to the pulp, less than 1 mm distance).
* Periapical pathology or signs of pulpal pathology.
* Possible prosthodontic restoration of teeth.
* Heavy occlusion and occlusal contacts or history of bruxism.
* Pulpitis, non-vital or endodontically treated teeth.
* Sever periodontal affection.
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.