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NCT Number: NCT07171775

This Study Aims to Clinically Assess and Radiographically Measure the Formed Dentin Bridge Over the Pulp, Utilizing Three-dimensional Imaging Following the Application of a Bioactive Restorative System Versus a Conventional Restorative System After Selective Caries Removal to Soft Dentin Over 2

This clinical trial aims to evaluate dentin bridge formation over the pulp following selective caries removal in permanent teeth with deep carious lesions (ICDAS scores 5-6). A total of 66 patients will be enrolled and randomly allocated to receive either a bioactive restorative system (bioactive universal adhesive combined with a bioactive bulk-fill resin composite) or a conventional non-bioactive restorative system. Clinical assessments, including pulp sensibility testing and patient-reported pain evaluation, together with three-dimensional radiographic analysis using cone beam computed tomography, will be conducted to assess the thickness and quality of reparative dentin bridge formation. Outcomes will be evaluated at baseline and during follow-up periods extending up to 24 months to compare the effectiveness of both restorative approaches in preserving pulp sensibility and promoting dentin-pulp complex repair.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This randomized controlled clinical trial is designed to evaluate the clinical and radiographic outcomes of a bioactive restorative system compared with a conventional restorative system following selective caries removal in permanent molars with deep carious lesions (ICDAS scores 5-6).

A total of 66 eligible patients will be recruited according to predefined inclusion and exclusion criteria and randomly allocated into two parallel groups. After selective removal of carious dentin to soft dentin, cavities will be restored using either a bioactive restorative system (bioactive universal adhesive combined with bioactive bulk-fill resin composite) or a non-bioactive restorative system (conventional universal adhesive and bulk-fill resin composite).

Clinical assessments will include evaluation of pulp sensibility and patient-reported pain, while radiographic assessment of dentin bridge formation-regarding presence, thickness, and quality-will be performed using three-dimensional cone beam computed tomography. Outcomes will be evaluated at baseline and during follow-up periods extending up to 24 months to compare the effectiveness of both restorative approaches in preserving pulp vitality and promoting dentin-pulp complex repair

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient-related criteria:

  • Adult patients (age: 18-40 years) of both genders.
  • Good oral hygiene.
  • Willing to sign the informed consent.
  • Cooperative patients who accept the follow-up period.

Tooth-related criteria:

  • Posterior permanent caries (ICDAS 5-6).
  • Radiographically, caries is extending 50% of dentine with a radiopaque layer between the carious lesion and the pulp chamber.
  • Sensitive teeth according to the cold pulp test.
  • Negative response in percussion test.

Exclusion criteria

Patient-related criteria:

  • Allergy to any of the restorative materials.
  • Patients undergoing orthodontic treatment with fixed appliances.
  • Pregnant women.
  • Patients with debilitating systemic diseases.
  • Patient who frequently uses analgesics or any drugs that could mask the pain.

Tooth-related criteria:

  • Teeth with previous restorations.
  • Spontaneous pain or prolonged pain (more than 15 s) after the sensitivity test (cold test), which would indicate irreversible pulpitis.
  • Negative sensibility tests, periapical radiolucency, and sensitivity to axial or lateral percussion.
  • Mobile teeth, indicating periodontal disease or trauma.
  • External or internal resorption.
  • Chipped teeth or Cuspal loss

Treatment and study plan

Experimental - Bioactive Restorative System

Procedure

Following selective caries removal to soft dentin, the cavity will be restored using a bioactive restorative system consisting of a bioactive universal adhesive followed by placement of a bioactive bulk-fill resin composite.

Active Comparator -Conventional Restorative System

Procedure

Following selective caries removal to soft dentin, the cavity will be restored using a conventional universal adhesive system followed by placement of a bulk-fill resin composite

Primary outcomes

  1. Clinical assessment of Pulp sensibility.

    Time frame: 24 months

    Thermal pulp test

Secondary outcomes

  1. Clinical assessment of pain.

    Time frame: 24 months

    (Patient-reported outcome measures) by Visual analogue scale The Visual Analogue Scale (VAS) will be used, by which 0 is no pain and 10 is severe pain.

    Pictures will be added to the same, as well as colors to guide the patient during selection of pain severity.

  2. Thickness and quality of Dentin bridge formation

    Time frame: 24 months

    Assess the dentin thickness by using the linear measurement tool and measuring the distance from the base of restoration to the pulp on sagittal, coronal, or cross-sectional images generated from CBCT scans after orientation of the orthogonal planes using the software's vertical and horizontal reference lines

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa Hamdy Saber E.H. Assistant lecturer, PhD

CONTACT

[email protected]

(+2) 01010200882

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical and Three-Dimensional Radiographic Assessment of Bioactive Restorative System Following Selective Caries Removal of Deep Lesions: A Two-Year Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Sep 15, 2025
Registry last updated
Jan 21, 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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