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This randomized clinical trial evaluated the clinical and radiographic outcomes of regenerative endodontic procedures performed using different irrigation activation protocols in immature permanent maxillary anterior teeth. Thirty patients were randomly assigned into three groups according to the use of laser-activated irrigation and number of visits. Clinical and cone beam computed tomographic (CBCT) outcomes were assessed over a 12-month follow-up period.
Thirty patients aged 9-25 years with non-vital immature permanent maxillary anterior teeth were included. Patients were randomly allocated into three equal groups based on the irrigation activation technique and number of visits. Regenerative endodontic procedures were performed following standardized protocols. Clinical evaluations were conducted at multiple follow-up intervals, while radiographic assessments using CBCT were performed at baseline, 6, and 12 months to evaluate root development and periapical healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regenerative endodontic procedures (REPs) without laser activation | Active Comparator | Regenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation without laser activation. |
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| Regenerative endodontic procedures (REPs) with laser activation (two visits) | Experimental | Regenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation with 810-nm diode laser activation. |
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| Regenerative endodontic procedures (REPs) with laser activation (single visit) | Experimental | Regenerative endodontic procedures completed in a single visit using sodium hypochlorite irrigation with 810-nm diode laser activation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regenerative Endodontic Procedure | Procedure | Regenerative endodontic procedure performed using sodium hypochlorite irrigation, intracanal double antibiotic paste, platelet-rich fibrin scaffold, and bioceramic coronal barrier according to a standardized clinical protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate at 12 Months | Clinical success defined as the absence of pain, tenderness to percussion, swelling, or sinus tract, assessed through standardized clinical examination. The outcome will be reported as the number and percentage of treated teeth demonstrating clinical success. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Root Length Measured by CBCT | Root length will be measured in millimeters (mm) using cone beam computed tomography (CBCT) imaging with a slice thickness of 0.5 mm, voxel size of 0.5 mm, and exposure parameters of 90 kV and 11 mA. Measurements will be obtained using OnDemand 3D software. The change in root length from baseline to 6 and 12 months will be calculated. | Baseline, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abeer M Darrag | Professor of Endodontics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinic, Department of Endodontics Faculty of Dentistry, Tanta University | Tanta | Gharbia Governorate | Egypt |
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| Laser-Activated Irrigation | Procedure | Irrigation activation using an 810-nm diode laser with a power of 1 W, applied for three cycles of 15 seconds with 15-second intervals, performed 1 mm short of the working length. |
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| Change in Root Canal Width Measured by CBCT | Root canal width will be measured in millimeters (mm) using CBCT imaging and OnDemand 3D software. | Baseline, 6 months, 12 months |
| Change in Apical Diameter Measured by CBCT | Periapical lesion size will be measured in millimeters (mm) using CBCT imaging and OnDemand 3D software. The reduction in lesion size from baseline to 6 and 12 months will be calculated. | Baseline, 6 months, 12 months |
| Change in Periapical Lesion Size Measured by CBCT | Periapical lesion size will be measured in millimeters (mm) using CBCT imaging and OnDemand 3D software. | Baseline, 6 months, 12 months |