Assessment of Collagen Plug for Alveolar Socket Sealing With Simultaneous Implant Placement in Maxillary Esthetic Zone
赞助:
Cairo University
合作者:
信息的提供 (责任方):
sara elsandouby，Cairo University
| 追踪信息 | |||
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| 首次提交日期 ICMJE | September 16, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | October 20, 2018 | ||
| 预计主要完成日期 | July 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
changes in soft tissue[ Time Frame: 3 month ] soft tissue changes will be measured in millimeters clinically and on a cast before and after the procedure changes in bone[ Time Frame: 6 month ] bone loss and gain will be measured in millimeters using cone beam computed tomography before and after the procedure |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Assessment of Collagen Plug for Alveolar Socket Sealing With Simultaneous Implant Placement in Maxillary Esthetic Zone | ||
| 正式标题 ICMJE | Assessment of Collagen Plug Versus Free Gingival Graft for Alveolar Socket Sealing With Simultaneous Implant Placement in Maxillary Esthetic Zone | ||
| 简要概况 | Following tooth extraction alveolar ridge will undergo dimensional changes and soft tissue may collapse. These changes may complicate the subsequent restorative procedure especially in the esthetic zone. It was observed that socket-healing process may be divided into three sequential, and frequently over-lapping phases: inflammatory, proliferative and modeling/remodeling. Implants placed in fresh extraction sockets alone wasn't found to prevent the resorption of the alveolar bone. |
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| 详细说明 | Alveolar socket preservation using primary flap closure technique utilizing free gingival graft in conjunction with bone substitutes didn't produce the desired effect on ridge preservation compared with bone substitutes alone. A clinical trial showed that achieving primary closure didn't present additional beneficial effect on preserving ridge width, however, the mucosa was significantly thicker and more coronally positioned. Also soft tissue graft has its limitations on covering graft material and socket preservation due to the higher morbidity given that the soft tissue graft has to be harvested from a donor site of the patient. Another options for socket seal are coronal advancement of buccal flap or rotating grafts from tissue adjacent to cover the defect but they have limitations such as altering the mucogingival line and creating a shallow vestibule. Lekovic et al. investigated the use of a non-resorbable polytetrafluroethylene membrane but it was found also to have its limitations as 30% of the membranes became exposed and as a result loss of bone height and width occurred. Also studies have found that using bone substitutes together with collagen membrane with primary closure of the socket has shown clear effects on preserving alveolar ridge height as well as ridge width, however, its limitation are flap dehiscence and subsequent membrane exposure and the increased cost. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
20 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 2019 | ||
| 预计主要完成日期 | July 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Patients with maxillary teeth in the esthetic zone (incisors/premolars) requiring extractions. - Both sexes. - No intraoral soft and hard tissue pathology. - No systemic condition that contraindicate implant placement. Exclusion Criteria: - Uncontrolled periapical infections - Heavy smokers more than 20 cigarettes per day. - Patients with systemic disease that may affect normal healing. - Psychiatric problems - Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site - Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands. | ||
| 性别 |
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| 年龄 | 最小年龄：25 Years ，最大年龄：60 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | sara elsandouby，Cairo University | ||
| 研究赞助商 ICMJE | Cairo University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Cairo University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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