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| ID | Type | Description | Link |
|---|---|---|---|
| Agreement No. D 304/18.12.2023 | Other Grant/Funding Number | Medical University of Sofia |
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The goal of this clinical trial is to learn whether hyaluronic acid (HyaDentĀ® BG) provides similar benefits to EmdogainĀ® when both are used with Bio-OssĀ® Collagen during periodontal surgery in adults with periodontal (intrabony) defects. The main questions it aims to answer are:
Does the treatment reduce probing pocket depth?
Does the treatment increase clinical attachment level?
Does the treatment increase radiographic bone fill?
Does the treatment change the gingival margin position?
Researchers will compare Bio-Oss Collagen + HyaDent BG with Bio-Oss Collagen + Emdogain to see whether HyaDent BG achieves similar improvements in clinical and radiographic outcomes as Emdogain.
Participants will:
Undergo periodontal surgery to treat the vertical bone defect(s), with either Bio-Oss Collagen + HyaDent BG or Bio-Oss Collagen + Emdogain.
Attend follow-up visits for periodontal measurements and radiographs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-Oss Collagen + HyaDent BG | Experimental | Periodontal regenerative treatment in which intrabony defects are treated with Bio-OssĀ® Collagen combined with HyaDentĀ® BG (cross-linked hyaluronic acid gel). The procedure follows standard periodontal surgical protocols. |
|
| Bio-Oss Collagen + Emdogain | Active Comparator | Periodontal regenerative treatment in which intrabony defects are treated with Bio-OssĀ® Collagen combined with EmdogainĀ®. The procedure follows standard periodontal surgical protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bio-Oss Collagen + HyaDent BG | Biological | Application of Bio-OssĀ® Collagen combined with HyaDentĀ® BG (cross-linked hyaluronic acid gel) during periodontal surgery for intrabony defects. Standard regenerative protocols are followed. |
| Measure | Description | Time Frame |
|---|---|---|
| periodontal pocket depth reduction | Before the surgery and 6 moths after the surgery | |
| Clinical attachment gain | Before the surgery and 6 months after surgery | |
| Radiographic bone fill | Before and 6 months after surgery. |
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Inclusion Criteria:
Adults over the age of 18 diagnosed with periodontal disease-Stage III or IV periodontitis;
Exclusion Criteria:
Medical conditions contraindicating surgical intervention;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departement of Periodontology, Faculty of Dental Medicine, Medical University of Sofia | Sofia | Bulgaria |
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| Bio-Oss Collagen + Emdogain | Biological | Application of Bio-OssĀ® Collagen combined with Emdogain during periodontal surgery for intrabony defects. Standard regenerative protocols are followed. |
|
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| C109069 | enamel matrix proteins |
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