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

Chronic Periodontitis Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04698317
• Other study ID #: = = ° ± µ ™ ®
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: October 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Concentrated Growth Factors
• Intrabony Periodontal Defect
• Periodontitis

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Malak Mohamed Shoukheba	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gingival index	gingival index will be recorded at baseline, 3, and 6 months at the site to be treated	6months
Primary	bleeding on probing	bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated	6 months
Primary	probing pocket depth	probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated	6 months
Primary	clinical attachment level	clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated	6 months
Primary	cone beam x ray measuring defect area	defect area will be recorded at baseline, and 6 months at the site to be treated	6 months
Primary	cone beam x ray measuring bone density	bone density will be recorded at baseline, and 6 months at the site to be treated	6 months