Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Dire… (NCT06369779) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment
Liechtenstein65 participantsStarted 2024-05-13
Plain-language summary
The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow and the new sculptable composite TM Fill for restoration of class I and class II cavities. The fillings are assessed according to selected FDI (Fédération Dentaire Internationale) criteria at baseline (7-10 days after placement of filling) and after 1, 6, 12, 24, 36 and 60 months.
Who can participate
Age range
18 Years – 65 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:
* Informed Consent signed by the subject
* Age: 18-65 years
* Indication Class I or II direct restorations in premolars or molars (Replacement of insufficient fillings due to secondary caries, fractures, insufficient marginal adaptation, loss of filling or primary caries)
* Cavity width must be at least half of the cusp tip distance
* Vital teeth, regular sensitivity
* Sufficient language skills
* No active periodontits
* Preoperative VAS (visual analogue scale) values \< 3 regarding tooth sensitivity and biting
Exclusion Criteria:
* Sufficient isolation of the cavity not possible
* Not completed hygiene phase or poor oral hygiene
* Missing antagonist, non-occlusion
* Missing tooth adjacent to the tooth to be treated
* Restorations replacing more than 1 cusp
* Caries profunda or very deep cavity
* Patients with a proven allergy to ingredients of the used materials (methacrylates) or local anesthetics (Articain, sulfite)
* Patients with severe systemic diseases
* Pregnancy
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.