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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| beta-tricalcium phosphate plus concentrated growth factors | Experimental | surgery plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group). |
|
| beta tricalcium phosphate alone(control group) | Placebo Comparator | surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open flap debridement | Procedure | Open flap for removal of diseased periodontal tissues and necrotic cementum |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| malak m shoukheba | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malak Mohamed Shoukheba | Tanta | 020 | Egypt |
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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).
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|
| 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 incorporating Concentrated Growth Factors in Periodontal Defect |
|
|
| use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone | Other | use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect |
|
|
| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C485817 | beta-tricalcium phosphate |
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