A Prospective, Randomized, Controlled, Multi-center Study With Direct Measure and Histological Evaluation Comparing Xenograft and Allograft for Posterior Buccal Dehiscence Extraction Site Ridge Preservation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months
研究概览
简要总结
To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked collagen membrane with xenograft + non-cross-linked collagen membrane for posterior extraction socket ridge preservation.
详细描述
Buccal bony wall loss is a common sequela following tooth extraction, and guided bone regeneration (GBR) is a common treatment for the regeneration of ridge form and volume preservation allowing dental implant placement. Many bone augmentation biomaterials are employed to accomplish GBR, and both the medical/ dental community and, subsequently, patients benefit from understanding whether a given GBR biomaterial might be more efficacious. To this end, a randomized, case series comparison of allograft + x-linked collagen membrane versus xenograft + non-x-linked collagen membrane would be beneficial to both the dental community and patients.
The study compares the effectiveness of demineralized freeze-dried bone allograft + x-linked collagen membrane with xenograft + non-x-linked collagen membrane for posterior region extraction socket ridge preservation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 to 70-yrs of age
- •Subject indicated for posterior tooth extraction (from 1st premolar to 1st molar) intended for implant placement, with adjacent teeth intact (for stent indexing)
- •Subjects with extraction site bony buccal dehiscences at least 1/3 the depth of socket and 1/3 the mesial-distal width of tooth socket
- •Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- •Subjects must be able and willing to follow study procedures and instructions.
排除标准
- •Subjects with a history of any tobacco use within the last six months.
- •Subjects with healing disorders (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude implant surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
- •Subjects taking intramuscular or intravenous bisphosphonates.
- •Subjects who have a known allergy or sensitivity to alginate, latex, collagen or acrylic.
- •Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration
- •Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
- •Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
结局指标
主要结局
Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months
时间窗: Six Months
The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.
次要结局
- Wound Closure at 4-weeks(4-weeks)
- New Bone Plus Graft Content at 6-months(Six Months)