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

Tanta University40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Periodontitis Intrabony Periodontal Defect Concentrated Growth Factors

Interventions

open flap debridementPROCEDURE

Open flap for removal of diseased periodontal tissues and necrotic cementum

use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factorsOTHER

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 aloneOTHER

use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect

Eligibility

Sex: ALLMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Malak Mohamed Shoukheba

Tanta, Egypt

Outcomes

Primary Outcomes

gingival index

gingival index will be recorded at baseline, 3, and 6 months at the site to be treated

Time frame: 6months

bleeding on probing

bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated

Time frame: 6 months

probing pocket depth

probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated

Time frame: 6 months

clinical attachment level

clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated

Time frame: 6 months

cone beam x ray measuring defect area

defect area will be recorded at baseline, and 6 months at the site to be treated

Time frame: 6 months

cone beam x ray measuring bone density

bone density will be recorded at baseline, and 6 months at the site to be treated

Time frame: 6 months

Data from ClinicalTrials.gov

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