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The treatment of intrabony defects in patients with aggressive periodontitis remains a challenging procedure and novel therapeutic strategies are sought. The purpose of this study is to compare the clinical and radiographic outcomes of using guided tissue regeneration (GTR) with radiation-sterilized allogenic bone grafts (material prepared in the Central Tissue Bank in Warsaw, Poland) versus guided tissue regeneration with xenogenic grafts (Bio-OssĀ®, Geistlich Biomaterials, Princeton, New Jersey, United States) in the treatment of localized intrabony defects in patients with aggressive periodontitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GTR + radiation-sterilize allogenic bone graft (TEST) | Experimental | The surgical procedure will be performed in line with minimally invasive surgical technique by Cortellini and Tonetti (2007). The intrabony defects will be debrided and the roots will be planned. The required quantity of radiation-sterilized allogenic bone graft will be delivered into intrabony defects. Subsequently, a trimmed collagen membrane will be placed over graft. The flaps will be sutured with non-absorbable modified internal mattress sutures. |
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| GTR + xenogenic graft (CONTROL) | Active Comparator | The surgical procedure will be performed in line with minimally invasive surgical technique by Cortellini and Tonetti (2007). The intrabony defects will be debrided and the roots will be planned. The required quantity of xenogenic graft will be delivered into intrabony defects. Subsequently, a trimmed collagen membrane will be placed over graft. The flaps will be sutured with non-absorbable modified internal mattress sutures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTR + radiation-sterilize allogenic bone graft | Device | Guided tissue regeneration of intrabony defects with collagen membrane (Bio-GideĀ® Perio, Geistlich Biomaterials) and radiation-sterilized allogenic bone graft from the Central Tissue Bank in Warsaw |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical attachment level (CAL) | CAL will be measured in millimeters on the study teeth at 6 locations as a distance from the cementoenamel junction to the bottom of the gingival sulcus. The average differences between 12 months and baseline measurements at the sites with the most advanced attachment loss at baseline will be compared. | Baseline and 12 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw | Warsaw | Mazowsze | 00-246 | Poland |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 11, 2025 | |
| Reset | May 28, 2025 |
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| GTR + xenogenic graft | Device | Guided tissue regeneration of intrabony defects with collagen membrane (Bio-GideĀ® Perio, Geistlich Biomaterials) and xenogenic graft (Bio-OssĀ®, Geistlich Biomaterials) |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 11, 2025 | May 28, 2025 |
| ID | Term |
|---|---|
| D010520 | Aggressive Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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