Clinical Evaluation of Dentin Replacement Materials in Posterior Composite Restorations

NCT07762651 — Not applicable, Enrolling by invitation, 30 participants, Tanta University

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RegistryNCT07762651
StatusEnrolling by invitation
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment30 (Estimated)
SponsorTanta University (Other)
ConditionsDental Caries, Composite Resins, Composite Restoration
InterventionsBiodentine, ACTIVA BioACTIVE, glass ionomer cement, everX Posterior, Flowable Resin Composite (Other)
Datesstart 2025-08-12, primary completion 2027-03-27 (estimated), completion 2027-03-29 (estimated), first posted 2026-08-13, last updated 2026-08-13
Locations1 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

-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.

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+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

+Arms and interventions

ArmTypeInterventionsDescription
BiodentineExperimentalOther: BiodentineParticipants 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 BioACTIVEExperimentalOther: ACTIVA BioACTIVEParticipants 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 CementExperimentalOther: glass ionomer cementParticipants 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 PosteriorExperimentalOther: everX PosteriorParticipants 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 ResinExperimentalOther: Flowable Resin CompositeParticipants 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
  • Biodentine (Other): Biodentine will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions
  • ACTIVA BioACTIVE (Other): ACTIVA BioACTIVE will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.
  • glass ionomer cement (Other): Glass ionomer cement will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.
  • everX Posterior (Other): everX Posterior will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.
  • Flowable Resin Composite (Other): Flowable resin composite will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.

+Outcome measures

Primary outcomes

  • marginal adaptation [18 months]: Clinical evaluation of marginal adaptation was conducted in accordance with the World Dental Federation (FDI) criteria by two calibrated examiners at baseline and after 6, 12, and 18 months. Each restoration was assessed and categorized according to the degree of conformity with the established criteria as follows: score 1, clinically excellent; scores 2 and 3, clinically satisfactory; and scores 4 and 5, clinically inadequate. Scores of 1-3 were considered indicative of clinical success, whereas scores of 4 or 5 were considered indicative of failure. Visual assessment was performed under adequate illumination using a high-intensity light source and a dental magnifying loupe to facilitate accurate evaluation. For statistical analysis, the Friedman test was used to assess within-group changes in restoration outcomes across the different follow-up periods. The Kruskal-Wallis test was applied to compare restoration outcomes among the different groups at each corresponding follow-up.

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Faculty of Dentistry, Tanta UniversityTanta, TantaEgypt

+Publications

  • Results publication: 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. PMID 36307111
  • Results publication: 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. PMID 36187866
  • Results publication: 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. PMID 35656656
  • Results publication: 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. PMID 39922996
  • Results publication: 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. PMID 35274436