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Enrolling by Invitation

NCT Number: NCT07762651

Clinical Evaluation of Dentin Replacement Materials in Posterior Composite Restorations

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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Key information

Conditions

Dental Caries Composite Resins Composite Restoration Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Tanta University

Tanta, 31527, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. marginal adaptation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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