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
Starting soon · Not applicable
Conditions studied: Deep Carious Lesions, Partial Caries Removal, Dentin Bridge
In brief
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.
Key facts
- Study ID
- NCT07171775
- Run by
- Cairo University
- People needed
- 66
- Starts
- 2026-06-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-01-21
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
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
Full record on ClinicalTrials.gov
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