Immediate Placement of the Straumann® Bone Level Tapered Implant With Early Loading in Single Tooth Gaps in the Maxilla and Mandible Compared to Delayed Placement
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 53
- 试验地点
- 6
- 主要终点
- Mean Crestal Bone Level Change
研究概览
简要总结
The aim of this randomized, controlled, multi-center study is to assess the clinical and radiographic outcomes of using a Straumann® Bone Level Tapered implant for immediate implantation following extraction of a tooth in the pre-molar and anterior region of the maxilla and mandible (test) compared to the outcomes of placing this implant in healed sites (control).
详细描述
The primary objective is to demonstrate that the change in mean peri-implant marginal bone level changes (mesial and distal) from loading to 12 months post-loading of the test treatment will not be worse than the control treatments.
The secondary objectives of the study are to assess differences in clinical and radiographic outcomes between the test and control treatments at 12 months post-loading by looking at implant success and survival, buccal bone dimensional changes, implant stability, soft tissue changes, subject satisfaction, and adverse events.
An additional objective is to assess long-term differences in clinical and radiographic outcomes, as measured in the primary and secondary objectives, over the span of two, three, four, and five years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 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 18 years of age
- •Subjects who are in need of a single tooth extraction in the pre-molar or anterior region of the maxilla or mandible (ADA tooth positions 4-13 and 20-29) and replacement with a dental implant.
- •Implants must be placed either immediately in an extraction socket or placed in a healed site (greater than 4 months healing) which has not been previously grafted.
- •Planned site for implant must have a natural tooth both mesially and distally in the adjacent tooth positions
- •Subjects must have opposing dentition (natural teeth, fixed or removable restorations)
- •There must be sufficient bone at the implant site to achieve primary stability
- •Subjects must be committed to the study and the required follow-up visits
- •Subjects must be in good general health as assessed by the Investigator
排除标准
- •Subjects with a systemic disease that would preclude dental implant surgery
- •Subjects with any contraindications for oral surgical procedures
- •Subjects with mucosal diseases (e.g., erosive lichen planus) in the localized area around the study implant site
- •Subjects with a history of local irradiation therapy in the head/neck area
- •Subjects with any untreated endodontic lesions or untreated periodontal disease adjacent to the implant site
- •Subjects receiving, or having a history of receiving, intravenous or subcutaneous antiresorptive agents, such as bisphosphonates
- •Subjects with severe bruxing, parafunctional habits, or temporomandibular joint dysfunction
- •Any implant sites where there will be a buccal dehiscence greater than 3 mm or there will be a fenestration of the implant
- •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 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 chew tobacco
- •Subjects who abuse alcohol or drugs
- •Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study
- •Subjects with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
结局指标
主要结局
Mean Crestal Bone Level Change
时间窗: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading
mean crestal bone level at 12 months - mean crestal bone level at implant loading (baseline) = Change in crestal bone level
Mean Crestal Bone Level Change
时间窗: Measured at implant loading (10-12 weeks after implant surgery) and 12 months post-loading
mean crestal bone level at 12 months - mean crestal bone level at implant loading (baseline) = Change in crestal bone level
次要结局
- Implant Success and Survival(12 months post-loading)
- Buccal Bone Dimensional Changes(Measured at Implant loading and at screening and 12 months post-loading)
- Implant Measure as Measured by ISQ at Implant Surgery(Implant surgery: Immediate Placement for Test Group = implant is placed at the time of tooth extraction. Delayed Placement is Control Group= implant is placed after 16-18 weeks of healing)
- Implant Stability as Measured by ISQ at Implant Loading(Implant Loading=implant surgery + 10 weeks (+/-3 weeks))
- Implant Stability as Measured by ISQ at Final Restoration(Final Restoration: 10 weeks post-loading (± 2 weeks))
- Change in Soft Tissue Measurements(Soft tissue measurements were taken and compared between the test and the control group at final restoration (10 weeks post loading) and 12 months (± 1 month) post implant loading (implant loading=implant surgery + 10 weeks (+/-3 weeks)).)
- Subject Satisfaction(12 months post-loading)
- Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months(Measured at each study visit and throughout 12 months)
- Implant Success and Survival(12 months post-loading)
- Buccal Bone Dimensional Changes(Measured at Implant loading and at screening and 12 months post-loading)
- Implant Measure as Measured by ISQ at Implant Surgery(Implant surgery: Immediate Placement for Test Group = implant is placed at the time of tooth extraction. Delayed Placement is Control Group= implant is placed after 16-18 weeks of healing)
- Implant Stability as Measured by ISQ at Implant Loading(Implant Loading=implant surgery + 10 weeks (+/-3 weeks))
- Implant Stability as Measured by ISQ at Final Restoration(Final Restoration: 10 weeks post-loading (± 2 weeks))
- Change in Soft Tissue Measurements(Soft tissue measurements were taken and compared between the test and the control group at final restoration (10 weeks post loading) and 12 months (± 1 month) post implant loading (implant loading=implant surgery + 10 weeks (+/-3 weeks)).)
- Subject Satisfaction(12 months post-loading)
- Number of Participants With Adverse Events and Adverse Device Effects Over 12 Months(Measured at each study visit and throughout 12 months)