NCT07457749 Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth
| NCT ID | NCT07457749 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | British University In Egypt |
| Condition | Proximal Cavities of Posterior Teeth |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-02-18 |
| Primary Completion | 2028-02-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-02-18 with a primary completion date of 2028-02-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The development of dental caries is multi-factorial mainly due to the presence of 4 elements which are: dental biofilm, fermentable carbohydrates , dental hard tissue and time. Other additional social and environmental factors can have a substantial impact on the onset and course of the disease. Dietary habits, oral hygiene, salivary flow and fluoride exposure are key factors that influence the susceptibility to dental caries. If dental caries is properly managed, it is a preventable and reversible disease. The proximal teeth surfaces are the most susceptible sites for demineralization from the acidic byproducts. In modern restorative dentistry, clinicians always seek solutions that streamline procedures, improve outcomes and reduce chair time for patients. Traditional light-cured composite systems often involve a complex seven step process which includes etching, priming, bonding and curing which consumes from 90 to 120 seconds to be completed. With each additional step, the risk of technique errors increases, potentially compromising the longevity of the restoration. Self-cure composites, with their simplified application process, are emerging as a preferred choice over the traditional seven-step composite materials. Recently, a novel self-cured high-performance bulk-fill restorative material has been introduced into the market (Stela, SDI, Victoria, Australia). It's particularly known for its "unlimited" depth of cure and self-adhesive properties.
Eligibility Criteria
Inclusion Criteria: 1. Subjects between the ages of 18-47 years old 2. Primary caries removal 3. Good or moderate oral hygiene 4. Free of periodontal diseases (probing depth and attachment levels within normal limits/ no furcation involvement/ no mobility) 5. Cooperative patients who agree to keep the scheduled recall appointments for data collection and maintenance Exclusion Criteria: 1. Composite or amalgam removal 2. Caries extended to the cemento-enamel junction in Class II caries 3. Grade II or III mobility 4. Considerable periodontal disease without treatment 5. Endodontically treated teeth with extensive loss of tooth tissues 6. Severe wear facets and/or parafunctional activities as clenching or nocturnal bruxism. 7. Subjects who are pregnant during the duration of the study 8. Subjects with high caries activity
Frequently Asked Questions
Who can join the NCT07457749 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 47 Years, studying Proximal Cavities of Posterior Teeth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07457749 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07457749 currently recruiting?
Yes, NCT07457749 is actively recruiting participants. Visit ClinicalTrials.gov or contact British University In Egypt to inquire about joining.
Where is the NCT07457749 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07457749 clinical trial?
NCT07457749 is sponsored by British University In Egypt. The trial plans to enroll 50 participants.