Clinical Evaluation of Dentin Replacement Materials in Posterior Composite Restorations
- Registry ID
- NCT07762651
- Source registry
- NCT
- Status
- ENROLLING_BY_INVITATION
- Phase
- NA
- Study type
- INTERVENTIONAL
- Sponsor
- Tanta University
- Enrollment
- 30
- Start date
- 2025-08-12
- Completion date
- 2027-03-29
- Last update
- 2026-08-13
Conditions
- Composite Restoration
- Dental Caries
- Composite Resins
Summary
This randomized controlled clinical trial is designed to clinically evaluate and compare the performance of five dentin replacement materials used beneath posterior composite restorations.
Detailed description
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
Interventions
- OTHER: Biodentine
- OTHER: Flowable Resin Composite
- OTHER: glass ionomer cement
- OTHER: everX Posterior
- OTHER: ACTIVA BioACTIVE
Inclusion criteria
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
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.
Primary outcomes
[{"measure":"marginal adaptation","timeFrame":"18 months"}]
Locations
- Faculty of Dentistry, Tanta University, Tanta, Egypt
Publications
- Ahmed B, Hamama HH, Mahmoud SH. Microshear Bond Strength of Bioactive Materials to Dentin and Resin Composite. Eur J Dent. 2023 Jul;17(3):917-923. doi: 10.1055/s-0042-1756692. Epub 2022 Oct 28.
- Harp YS, Montaser MA, Zaghloul NM. Flowable fiber-reinforced versus flowable bulk-fill resin composites: Degree of conversion and microtensile bond strength to dentin in high C-factor cavities. J Esthet Restor Dent. 2022 Jun;34(4):699-706. doi: 10.1111/jerd.12901. Epub 2022 Mar 11.
- Hafez ME, Abd El-Ghany AA, Taha AI, Amin A. In vitro assessment of fracture resistance of endodontically treated teeth restored with short fiber reinforced resin based composite and ceramic overlays. BMC Oral Health. 2025 Feb 8;25(1):211. doi: 10.1186/s12903-025-05480-x.
- Choudhury WR, Nekkanti S. Mechanical Properties of SDR and Biodentine as Dentin Replacement Materials: An In Vitro Study. J Contemp Dent Pract. 2022 Jan 1;23(1):43-48.
- Karale R, Prathima BJ, Prashanth BR, Shivaranjan NS, Jain N. The effect of bulk-fill composites: Activa and Smart Dentin Replacement on cuspal deflection in endodontically treated teeth with different access cavity designs. J Conserv Dent. 2022 Jul-Aug;25(4):375-379. doi: 10.4103/jcd.jcd_53_22. Epub 2022 Aug 2.
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