Clinical Performance of Bioactive Restorative Materials
Turkey (Türkiye)20 participantsStarted 2024-11-01
Plain-language summary
The aim of this clinical study is to evaluate the performance of three different bioactive restorative materials against a composite resin for a period of 9 months.
This randomized, split-mouth, single-center trial was performed on patients having occlusal caries (ICDAS 3 and 4) in both molars of the same jaw. The restorative materials used were Tetric N-Ceram Bulk-fill (control, Ivoclar Vivadent, Liechtenstein), Stela (SDI, Australia), Cention Forte (Ivoclar) and Activa BioActive Restorative (Pulpdent, USA). The restorations were evaluated at baseline, 3-6 and 9-month according to FDI-2 criteria, in terms of functional, biological, and aesthetic parameters, by two experienced evaluators.
Who can participate
Age range
20 Years – 34 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:
* Individuals over the age of 16 with permanent dentition
* Individuals with a total of four vital molar teeth requiring restoration (ICDAS 3-4), two on each side of the same jaw
* Individuals with posterior contact with antagonist teeth
* Individuals who are reliable, cooperative, and willing to participate in periodic follow-ups
Exclusion Criteria:
* Individuals whose antagonist teeth were missing or have crowns, bridges, etc.
* Individuals with history of alcohol, drug, or medication addiction.
* Individuals with pulp exposure during cavity preparation or a cavity depth exceeding 2-4 mm.
* Individuals known to be unable to attend follow-up appointments.
* Individuals with allergies to the products used in the procedure.
* Individuals with severe tooth grinding or bruxism.
* Individuals with caries conditions classified as ICDAS 5 and 6.
* Pregnant or breastfeeding individuals and individuals planning pregnancy during the study.
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
FDI-2 evaluation criteria for functional properties