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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Periodontitis, Intrabony Periodontal Defect, Concentrated Growth Factors

Intervention / Treatment
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* Procedure: open flap debridement
* Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors
* Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 40 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).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: beta-tricalcium phosphate plus concentrated growth factors<br>surgery plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group). | Procedure: open flap debridement<br>* Open flap for removal of diseased periodontal tissues and necrotic cementum<br>* Other names: periodontal surgery;Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors<br>* use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate incorporating Concentrated Growth Factors in Periodontal Defect<br>* Other names: regenerative surgery;|
| Placebo Comparator: beta tricalcium phosphate alone(control group)<br>surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), | Procedure: open flap debridement<br>* Open flap for removal of diseased periodontal tissues and necrotic cementum<br>* Other names: periodontal surgery;Other: use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone<br>* use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect<br>* Other names: Regenerative surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gingival index | gingival index will be recorded at baseline, 3, and 6 months at the site to be treated | 6months | 
| bleeding on probing | bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated | 6 months | 
| probing pocket depth | probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated | 6 months | 
| clinical attachment level | clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated | 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 | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beta-Tricalcium Phosphate, regeneration, concentrated growth factors