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

Tanta University

Status and phase: Completed; Phase 2

Conditions: Concentrated Growth Factors; Chronic Periodontitis; Intrabony Periodontal Defect

Treatments: Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors; Procedure: open flap debridement; Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone

Study type: Interventional

Funder types: Other

Identifiers

NCT04698317

≤ ≥ ° ± µ ™ ®

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

beta-tricalcium phosphate plus concentrated growth factors

Experimental group

Description:

surgery plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).

Treatment:

Procedure: open flap debridement

Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors

beta tricalcium phosphate alone(control group)

Placebo Comparator group

Description:

surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group),

Treatment:

Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone

Procedure: open flap debridement