This randomized controlled clinical study aims to evaluate the clinical performance of five different bulk-fill composite materials representing distinct technological approaches according to the World Dental Federation (FDI) criteria. The materials include a thermoviscous bulk-fill composite applied with preheating, a sonic-activated bulk-fill composite, a flowable bulk-fill composite, an ORMOCER-based bulk-fill composite, and a conventional bulk-fill composite. Restorations will be clinically assessed at baseline, 1 month, 6 months, and 12 months for esthetic, functional, and biological outcomes.
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:
* Patients aged 18 years and older
* Patients in good general health (systemically healthy)
* Patients with good oral hygiene
* Patients with good periodontal health
* Presence of at least one posterior tooth requiring restoration
* Teeth must be vital and asymptomatic
* Teeth must have proximal contact with adjacent teeth on both mesial and distal surfaces
* Teeth must be in functional occlusion with an antagonist tooth
* Presence of at least one carious lesion not extending deeper than two-thirds of dentin, with a clinical ICDAS code ≤ 3
* Absence of periapical pathology confirmed by radiographic evaluation
* Patients who voluntarily agree to participate and provide written informed consent
Exclusion Criteria:
* Presence of any systemic disease
* Poor oral hygiene
* Presence of active or severe periodontal disease
* Teeth with previous restorations or endodontic treatment
* Non-vital (devitalized) or symptomatic teeth
* Patients who are pregnant or breastfeeding
* Patients undergoing active orthodontic treatment
* Presence of parafunctional habits (e.g., bruxism) or xerostomia
* Current tobacco use or history of heavy smoking
* Patients unwilling or unable to attend follow-up visits
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
Clinical performance according to FDI criteria
Timeframe: Baseline (1 month), 6 months, and 12 months