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

Phase 2

Completed

• Conditions: Concentrated Growth Factors; Intrabony Periodontal Defect; Chronic Periodontitis
• Interventions: Procedure: open flap debridement; Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone; Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors

• Registration Number: NCT04698317
• Lead Sponsor: Tanta University

Brief 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.

Study Timeline

• Study First Submitted: 2020-12-31
• Study Start: 2021-01-01
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• systemically healthy patients were selected
• patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
• Patients should demonstrate their ability to maintain good oral hygiene

Exclusion Criteria

• Smokers and pregnant patients.
• Medically compromised patients and systemic conditions precluding periodontal surgery.
• Subjects who do not comply with oral hygiene measures as evidenced in recall visits.
• Sites with tooth mobility
• Restoration or caries in the site to be treated or non-vital tooth
• Restoration or caries in the site to be treated or non-vital tooth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
beta tricalcium phosphate alone(control group)	open flap debridement	surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group),
beta-tricalcium phosphate plus concentrated growth factors	open flap debridement	surgery plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
beta tricalcium phosphate alone(control group)	use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone	surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group),
beta-tricalcium phosphate plus concentrated growth factors	use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors	surgery plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).

Primary Outcome Measures

Name	Time	Method
bleeding on probing	6 months	bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated
clinical attachment level	6 months	clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
gingival index	6months	gingival index will be recorded at baseline, 3, and 6 months at the site to be treated
cone beam x ray measuring defect area	6 months	defect area will be recorded at baseline, and 6 months at the site to be treated
probing pocket depth	6 months	probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
cone beam x ray measuring bone density	6 months	bone density will be recorded at baseline, and 6 months at the site to be treated

Trial Locations

Locations (1)

Malak Mohamed Shoukheba; 🇪🇬 Tanta, Egypt