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

NCT07171775 | Not Yet Recruiting DMC

• 1 other identifier: CU-2025-09
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Deep Carious Lesions; Partial Caries Removal; Dentin Bridge

Keywords

deep caries; partial caries removal; selective caries removal; dentin bridge; Bioactive; universal adhesive

Outcome Measures

Primary Outcomes (1)

• Clinical assessment of Pulp sensibility.

  Thermal pulp test

  24 months

Secondary Outcomes (2)

• Clinical assessment of pain.

  24 months

• Thickness and quality of Dentin bridge formation

  24 months

Study Arms (2)

Bioactive Restorative System

EXPERIMENTAL

Experimental Group (Bioactive Restorative System):

Procedure: Experimental - Bioactive Restorative System

Conventional Restorative System

ACTIVE COMPARATOR

Control Group (Conventional Restorative System)

Procedure: Active Comparator -Conventional Restorative System

Interventions

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.

Bioactive Restorative System

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

Conventional Restorative System

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Esraa Hamdy Saber E.H. Assistant lecturer, PhD

CONTACT

(+2) 01010200882; esraah.hamdy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blinded trial: participants and outcome assessors/analysts will be blinded to treatment allocation. The operator (E.H.) cannot be blinded due to differences in handling and placement of the two materials
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 15, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share