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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioactive Restorative System | Experimental | Experimental Group (Bioactive Restorative System): |
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| Conventional Restorative System | Active Comparator | Control Group (Conventional Restorative System) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical assessment of Pulp sensibility. | Thermal pulp test | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Thickness and quality of Dentin bridge formation |
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Inclusion Criteria:
Patient-related criteria:
Tooth-related criteria:
Exclusion Criteria:
Patient-related criteria:
Tooth-related criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esraa Hamdy Saber E.H. Assistant lecturer, PhD | Contact | (+2) 01010200882 | esraah.hamdy@dentistry.cu.edu.eg |
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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
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| 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 |
|
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 |
| 24 months |