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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Deep Carious Lesions
• Partial Caries Removal
• Dentin Bridge

Interventions

Type	Name	Description
PROCEDURE	Experimental - Bioactive Restorative System	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.
PROCEDURE	Active Comparator -Conventional Restorative System	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

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-12-01
• Completion: 2028-06-01
• First posted: 2025-09-15
• Last updated: 2026-01-21