NCT04698317

Beta-Tricalcium Phosphate and Concentrated Growth Factors in Treatment of Intra-bony Defect Randomized Clinical Trial

Biodegradable Gelatin Sponge Loaded With Beta-Tricalcium Phosphate Sponges Incorporating Concentrated Growth Factors in the Treatment of Intra-bony Pocket Randomized Clinical and Radiographic Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This clinical study aimed to evaluate the efficacy of biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors in the treatment of periodontal intra-bony defects, as compared with biodegradable gelatin/beta-tricalcium phosphate sponges alone.

Detailed description

40 intra-bony defects in 40 patients will be selected from outpatient clinic of Oral Periodontology Clinic Faculty of Dentistry, Tanta University to participate in this study. Each defect had intra-bony depth \> or = 4 mm and probing pocket depth (PPD) \> or = 6 mm. Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group). Gingival index (GI), bleeding on probing, Probing pocket depth and clinical attachment level (CAL) will assessed at baseline, 3, and 6 months at the site to be treated. Cone beam radiographs evaluation will be taken at baseline, and 6 months after surgery.

Conditions

• Chronic Periodontitis
• Intrabony Periodontal Defect
• Concentrated Growth Factors

Interventions

Type	Name	Description
PROCEDURE	open flap debridement	Open flap for removal of diseased periodontal tissues and necrotic cementum
OTHER	use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors	use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate incorporating Concentrated Growth Factors in Periodontal Defect
OTHER	use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone	use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2021-01-06
• Last updated: 2021-10-04

Locations

1 site across 1 country: Egypt