Performance of Reinforced 3D-Printed Versus Direct Bulk-Filled Resin Composites for Restoring Ext… (NCT07429747) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Performance of Reinforced 3D-Printed Versus Direct Bulk-Filled Resin Composites for Restoring Extensive Class II Cavities in Vital Molars
50 participantsStarted 2026-02-20
Plain-language summary
Most published research on 3D-printed restorative materials is laboratory-based, focusing primarily on mechanical performance and material properties under controlled conditions. While such studies provide important foundational data, they do not fully replicate the complexity of the oral environment. Only a limited number of clinical investigations have directly compared 3D-printed restorations with conventional direct composite restorations in Class II cavities Furthermore, the integration of a digital workflow introduces additional costs and time requirements related to equipment, software, and training. These factors must be justified by demonstrable improvements in clinical outcomes or cost-effectiveness. By evaluating both clinical performance and economic impact, this trial aims to generate practical, real-world evidence that can guide clinicians in selecting appropriate restorative materials and techniques for routine dental practice.
Who can participate
Age range
22 Years – 45 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:
Patient-related:
* Adults aged 22 to 45 years.
* Low to moderate caries risk.
* Normal occlusion.
* No signs or symptoms of temporomandibular joint disorders.
* Satisfactory oral hygiene.
* Medically fit to receive routine restorative dental treatment.
Lesion-related:
* Permanent molar requiring a compound Class II restoration.
* Primary carious lesion classified as ICDAS score 5.
* Presence of an adjacent tooth and a sound opposing tooth in occlusion.
* No clinical signs or symptoms of irreversible pulpitis in the involved, adjacent, or opposing teeth.
* No radiographic evidence of periapical pathology.
Exclusion Criteria:
Patient-related:
* Bruxism.
* Poor cooperation.
* Inability or unwillingness to attend follow-up visits.
* Anticipated travel during the study period.
* Poor oral hygiene.
* Chronic or advanced periodontitis.
* Known allergy to any study materials.
* Pregnant or breastfeeding women.
Lesion-related:
* Teeth with visible fractures or cracks.
* Rampant caries.
* Defective restorations on adjacent or opposing teeth.
* Atypical extrinsic staining that may interfere with evaluation.
* Radiographic signs of apical pathology.
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
Number of participants with a change in functional properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
Timeframe: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
2
Number of participants with a change in Biological properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
Timeframe: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.
3
Number of participants with a change in Esthetic properties of the restoration using (FDI) World Dental Federation clinical criteria for the evaluation of direct and indirect restorations
Timeframe: after restoration placement at 1 day (baseline), 6 months,12 months, and 18 months.