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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Allergy to any of the restorative materials.

Patients undergoing orthodontic treatment with fixed appliances.

Pregnant women.

Patients with debilitating systemic diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental - Bioactive Restorative System

    Procedure/Surgery

    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/Surgery

    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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Bioactive Restorative SystemExperimental treatment 1 intervention
Group B: Conventional Restorative SystemActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical assessment of Pulp sensibility.

Thermal pulp test

Time frame
24 months

Secondary outcomes

1

Clinical assessment of pain.

(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.

Time frame
24 months
2

Thickness and quality of Dentin bridge formation

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

Time frame
24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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