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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04698317
Other study ID # = = ° ± µ ™ ®
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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