| Registry | NCT07762651 |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Tanta University (Other) |
| Conditions | Dental Caries, Composite Resins, Composite Restoration |
| Interventions | Biodentine, ACTIVA BioACTIVE, glass ionomer cement, everX Posterior, Flowable Resin Composite (Other) |
| Dates | start 2025-08-12, primary completion 2027-03-27 (estimated), completion 2027-03-29 (estimated), first posted 2026-08-13, last updated 2026-08-13 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Dental Caries All trials for Composite Resins All trials of Biodentine All trials of ACTIVA BioACTIVE
This randomized controlled clinical trial is designed to clinically evaluate and compare the performance of five dentin replacement materials used beneath posterior composite restorations.
Thirty patients ranging in age from 20 to 35 years will be enrolled into the study. This study will be designed as a randomized controlled clinical trial including patients requiring six Class I restorations. Participants will be randomly allocated into six groups according to the type of dentin replacement material used: Group I (Biodentin), Group II (Activa Bioactive), Group III (Glass ionomer cement), Group IV (Ever x posterior), and Group V (Flowable resin). Restorations will be placed following standardized cavity preparation and manufacturer instructions. Clinical evaluation will be performed at baseline and 6, 12, and 18 months using modified FDI criteria, assessing retention, marginal integrity, surface roughness, anatomical form, postoperative sensitivity, and secondary caries. Data will be collected and statistically analyzed
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Biodentine | Experimental | Other: Biodentine | Participants will receive posterior Class I composite restorations incorporating Biodentine as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. |
| ACTIVA BioACTIVE | Experimental | Other: ACTIVA BioACTIVE | Participants will receive posterior Class I composite restorations incorporating ACTIVA BioACTIVE as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. |
| Glass Ionomer Cement | Experimental | Other: glass ionomer cement | Participants will receive posterior Class I composite restorations incorporating conventional glass ionomer cement as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. |
| everX Posterior | Experimental | Other: everX Posterior | Participants will receive posterior Class I composite restorations incorporating everX Posterior as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions. |
| Flowable Resin | Experimental | Other: Flowable Resin Composite | Participants will receive posterior Class I composite restorations incorporating flowable resin composite as the dentin replacement material according to the standardized clinical protocol and manufacturer's instructions |
Sex: All, ages: 25 Years to 40 Years, accepts healthy volunteers
Inclusion Criteria: * Patients who are medically able to undergo routine dental restorative treatment. * Patients willing and able to provide written informed consent. * Patients with adequate oral hygiene and periodontal health for participation in the study. * Patients requiring posterior Class I restorations Exclusion Criteria: * Patients with systemic conditions that contraindicate routine dental treatment. * Patients unable or unwilling to provide informed consent. * Patients with poor compliance or inability to attend scheduled follow-up visits. * Teeth with clinical or radiographic evidence of irreversible pulpitis, pulp necrosis, or periapical pathology.
| Facility | City | Country | Status |
|---|---|---|---|
| Faculty of Dentistry, Tanta University | Tanta, Tanta | Egypt |