A Prospective Human Clinical Study to Assess Primary Stability and Change in Stability by Resonance Frequency Analysis of Immediately Inserted and Restored Dental Implants Using pH-Modified Tetranite® Implant Stabilization Material
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- RevBio
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Implant Stabilization by Resonance Frequency Analysis
研究概览
简要总结
The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite Implant Stabilization Material (TN-ISM) in delivering enhanced stability to immediately restored dental implants inserted into fresh extraction sockets, with both clinical and patient-related successful outcomes.
详细描述
The purpose of the present study is to evaluate the safety and efficacy of a single stage approach using Tetranite Implant Stabilization Material (TN-ISM). The purpose of the efficacy component of this study is a composite comprising: (1) First - To demonstrate and evaluate the ability of TN-ISM to achieve immediate implant stabilization in sites otherwise unable to provide primary stability without requiring the delay in treatment imposed by the current multi-staged standard-of-care method; (2) Second - To demonstrate and evaluate the ability of TN-ISM to achieve increasing short-term stabilization of implants as the device undergoes initial resorption and replacement with new bone; (3) Third - To demonstrate the ability of TN-ISM to aid in the maintenance of alveolar ridge contours without buccal plate collapse and loss of crestal bone height; and Fourth (4) - To demonstrate and evaluate the ability of a TN-ISM stabilized implant to achieve implant success (after criteria of Buser, et. al 1) after 12 months in situ while the device undergoes significant resorption, facilitates osteoconduction, and replacement with new bone. In addition to the Primary Endpoints of establishing the Safety and Efficacy of Implant Stabilization and Implant Success throughout the initial 12 months of post-implant and device placement, the study also assesses several secondary endpoints over the course of the study and one-year follow-up, as outlined in the sections below. These include assessment of incidence, duration, and severity of adverse effects and events; assessment of increasing implant stiffness; assessment of bone levels, bone volumetric changes; patient satisfaction surveys, and assessment of periodontal and peri-implant health integral to implant success.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have voluntarily signed the informed consent form before any study related procedures;
- •Subjects must be males or females who are a minimum of 20 years of age;
- •Subjects who require a single anterior maxillary tooth extraction and desire a replacement with a dental implant and immediate temporary crown. Candidate subjects may require more than one extraction, and all sitesbut only one site will be considered for inclusion in the study;
- •Subjects must have opposing dentition (natural teeth, fixed or removable restorations);
- •Subjects must be committed to the study and the required follow-up visits;
- •Subjects must be American Society of Anesthesiology Grade (ASA) I or ASA II;
- •Subjects who present with a sound bony housing with a visible buccal plate evident at the crest and fenestrations limited to <5.0mm diameter on a cone beam CT;
- •Subjects who present with a sound bony housing with a visible buccal plate evident at the crest and dehiscences limited to <3.0mm in any direction on a cone beam CT;
- •There must be sufficient bone height crestal to critical anatomical structures, i.e., the piriform foramen, and maxillary sinus, to safely place a dental implant within the bone contours. Extraction sockets should be able to accommodate an implant ≥9.0mm in length;
- •Anatomical conditions must be present to allow an implant crown restoration to be placed at the candidate site, e.g., sufficient interocclusal space, incisal Class1 or Class 2 Div 1 relation, appropriate angulation of the ridge, etc.
排除标准
- •There is at least 2mm of apical bone below the apex of the extraction socket for positive seating of the implant;
- •Any implant site in which placement of the selected implant leaves an (Horizontal Dimension of Defect) HDD > 2mm in the buccal direction between the implant surface and the labial plate at the most coronal aspect of the extraction socket.
结局指标
主要结局
Implant Stabilization by Resonance Frequency Analysis
时间窗: 12 months
The primary endpoint is sufficient bone-to-implant interfacial stiffness post-placement of the implant stabilized by TN-ISM, whereby, sufficient bone-to-implant interfacial stiffness is measured by Resonance Frequency Analysis (RFA) expressed as mean Implant Stability Quotient (ISQ) at 12 months post TN-ISM device and implant placement. For the study to be considered successful, the lower bound of the one-sided 97.5% confidence interval for the mean ISQ should exceed the clinical threshold of 60.
次要结局
- Implant Stabilization by Resonance Frequency Analysis(15 minutes, 3 months, and 7 months)
- Per-implant tissue health(12 months)
- Patient Satisfaction(12 months)
- Device Related Adverse Events(12 months)
- Implant Stabilization by Manual Palpation(15 minutes, 1 month, 3 months, and 7 months)
- Implant Success (Composite Measure)(12 months)
- Volume Loss(12 months)