Clinical Assessment of Giomer Based Technology Versus Smart Bioactive Restoration in Carious Clas… (NCT05466461) | Clinical Trial Compass
CompletedNot Applicable
Clinical Assessment of Giomer Based Technology Versus Smart Bioactive Restoration in Carious Class V Cavities
Egypt34 participantsStarted 2023-06-01
Plain-language summary
This study will compare between S-PRG-containing injectable flowable resin composite (Beautifil Flow Plus X) and smart bioactive flowable resin composite (Activa bioactive restorative) through evaluation of the modified USPHS clinical performance in patients with carious class V moderately deep cavities.
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:
* ages 18 to 55 years.
* Male or female patients.
* Patients with no history of allergic reactions to methacrylate compounds and in good general health.
* Patients with good general health.
* Patients with good recall availability. Patients required Class V restoration
* Vital teeth with normal appearance and morphology.
* Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure.
* Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and/or abnormal tooth mobility .
* No defects and lesions for other operative intervention, occlusal and proximal contacts with adjacent teeth.
Exclusion Criteria:
* Patients with history of any adverse reaction to clinical materials of the types to be used in the evaluation.
* Pregnant and lactating females.
* Any patients with medical and/or dental histories which could possibly complicate the provision of the proposed restoration and/or influence behavior and performance of the restorations in clinical service.
* They are included in the evaluation of other restorative materials and systems involving the anterior and/or posterior teeth.
* Patients who maintain an unacceptable standard of oral hygiene.
* Teeth with noncarious cervical lesions.
* Severe tooth sensitivity.
* Non-vital or fracture or cracked teeth.
* Tooth with defective restoration.
* Teeth with advanced periodontal diseases.
* There is evidence occlu…
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
Assessment of Modified USPHS Criteria (Marginal discoloration) change over time
Timeframe: Change between baseline,6 months and 12 months