Immediate Placement and Stabilization of Dental Implants With Tetranite® Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites That Fail to Provide Adequate Primary Stability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RevBio
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Implant Success (Modified Buser Criteria)
研究概览
简要总结
This study is to determine if a new bone adhesive is useful in stabilizing dental tooth implants. Data collected from the study will examine the strength, performance, and the safety of the material.
详细描述
This is a prospective, multi-center, single arm, pilot clinical study evaluating the use of TN-SM for implant stabilization immediately after tooth extraction. The purpose of this pilot study is to test performance characteristics and capabilities of study design, recruitment criteria, procedures, measures, and operational strategies that are under consideration for use in a subsequent, larger clinical pivotal study. The purpose of the subsequent study will be to provide data demonstrating the safety and efficacy for the use of TN-SM to provide immediate and continued stabilization of implants placed into otherwise unstable sites. Use of TN-SM eliminates the need for the standard practice of bone grafting after tooth extraction and staged implant placement, significantly shortening the overall length of this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent;
- •Require tooth extraction and replacement with dental implant;
- •Have opposing dentition;
- •Committed to Study and Follow-up period;
- •ASA I or II;
- •Planned "implant site" must have 1 adjacent tooth;
- •Sufficient bone Height for safe dental implant placement;
- •At least 2 mm of apical bone for seating of implant.
排除标准
- •Any significant disease that would preclude a dental implant
- •Any oral surgery contraindications
- •Subjects with mucosal Disease
- •Subjects with bone diseases or conditions (e.g. Paget's disease, fibrous dysplasia, history of osteomyelitis, etc.) in the region of the potential study implant site;
- •Subjects with a history of local radiation therapy in the head/neck area or osteonecrosis of the jaws;
- •Subjects with any acute and untreated endodontic lesions or periodontal disease;
- •Subjects receiving, or having a recent or long-term history of receiving, oral or parenteral anti-osteoclastic agents [e.g., bisphosphonates, Xgeva® and Prolia® (denosumab); Forteo® (teriparatide), strontium ranelate, etc.], or anti-angiogenesis factors;
- •Subjects who have major active substance abuse problems (e.g., alcoholism, opiate addiction, methamphetamine abuse, etc.);
- •Subjects who are pregnant or intending to become pregnant during the duration of the study;
- •Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day or equivalent of electronic cigarette vaping) or chew tobacco;
- •Subjects with inadequate oral hygiene or who are unmotivated for adequate home care;
- •Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene;
- •Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study;
- •Subjects who are allergic or otherwise sensitive to any materials likely encountered during the course of the study (e.g. titanium, suture materials, local anesthetics);
- •Subjects with conditions or circumstances, which, in the opinion of the Investigator, would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
- •Any site into which the implant is not or cannot be placed during the same visit as the extraction;
- •Any implant site where there is a dehiscence or fenestration of buccal or lingual plates of bone greater than 5mm in any direction.
结局指标
主要结局
Implant Success (Modified Buser Criteria)
时间窗: 6 months
The primary endpoint is a composite measure of implant success (after criteria of Buser, et. al.1) at six-month post-functional loading consisting of: * Presence of the implant at its site of implantation; and, * Absence of a recurrent peri-implant infection with suppuration; and, * Absence of mobility, defined as: * Lack of implant rotation subjected to 20 Ncm of clockwise torque applied 15 minutes after implant placement; and. * Lack of implant rotation subjected to 35 Ncm of clockwise torque applied 13 weeks after implant placement; and, * No construct mobility upon palpation at 6 months post-functional loading; and, * Absence of encapsulation defined as continuous radiolucency around the implant in a periapical radiograph.
次要结局
- Adverse Events (Serious, Device Related)(12 months)