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| Name | Class |
|---|---|
| São Paulo State University | OTHER |
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The goal of this clinical trial is to compare the maintenance of socket volume in the groups treated by a resorbable regenerative membrane (Plenum® Guide) covered or not with mucous tissue, with control without treatment. The main question it aims to answer is the effectiveness of the Plenum® Guide membrane in the process of guided bone regeneration, exposed or not, through the preservation and neoformation of bone tissue in the tooth extraction socket procedures.
Patients will be submitted to tooth extraction, the surgical procedure of guided bone regeneration using regenerative membranes and synthetic bone graft, and subsequent installation of dental implants. The 05 groups will be compared to observe if the proposed medical devices effectively will maintain the socket's bone volume during the healing phase before the installation of the dental implants (1. socket filled only with clot, 2. socket associated with exposed absorbable membrane, 3. socket associated with covered absorbable membrane, 4. socket filled with synthetic bone graft and covered absorbable membrane, 5. socket filled with synthetic bone graft and exposed absorbable membrane).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| socket | Sham Comparator | Tooth extraction socket filled only clot. |
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| Socket associated with exposed absorbable membrane | Active Comparator | Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region. |
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| Socket associated with covered absorbable membrane | Active Comparator | Socket filled with clot and covered with the Plenum® Guide membrane and covered by mucosa (gingival tissue) in the intraoral region. |
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| Socket filled with synthetic bone graft and covered absorbable membrane | Experimental | Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region. |
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| Socket filled with synthetic bone graft and exposed absorbable membrane | Experimental | Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plenum® Guide | Device | Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of alveolar repair | Accessed via cone beam computed tomography | Comparison of exams obtained in the preoperative period, immediate postoperative period (7 days) and late postoperative period (3 months) |
| Rate of newly formed bone tissue, soft tissue and residual bone graft material | immunohistochemical analyzes of histological sections | 4 months after extraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo Hochuli Vieira, PhD | Contact | +55(16)3301-6459 | eduardo.hochuli@unesp.br | |
| Sybele Saska Specian, PhD | Contact | +55(11)31099068 | pesquisa@plenum.bio |
| Name | Affiliation | Role |
|---|---|---|
| Sybele Saska Specian, PhD | Study Director | Study Director |
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| ID | Term |
|---|---|
| D014081 | Tooth Extraction |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
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| Plenum® Oss | Device | Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets. |
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| Tooth extraction | Procedure | Tooth extraction and subsequent surgical procedure of guided bone regeneration. |
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