Randomized, Controlled Clinical Study Comparing Submerged vs. Trans-mucosal Placement of P.004 Implants in the Anterior Maxilla and Mandible by Evaluation of the Change in Bone Level Between 1st Stage Surgery and 6 Months Post Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 11
- 主要终点
- Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)
研究概览
简要总结
The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to submerged implant placement
详细描述
The primary objective of this study is to determine the level at which the bone can be maintained in relation to the implant shoulder for the P.004 two-stage implant when placed in a submerged or a trans-mucosal procedure in single tooth gaps in the anterior region. The primary parameter will be measured by radiography 26 weeks after loading of the implant.
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
- •Males and females >18 years of age.
- •Implant placement planned in the anterior maxilla or mandible (FDI tooth numbers 21 - 25, 11 - 15, 31-35, 41-45).
- •Tooth site must have a natural tooth both mesially and distally in the adjacent tooth positions
- •Opposing dentition of natural teeth, or tooth or implant-supported fixed restorations.
- •Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann P.004 SLActive implant of 8, 10, 12, or 14 mm length.
- •Presence of a sufficient band of keratinized mucosa (min. 2 mm) to allow surgical manipulation and suturing according to the protocol
- •Signed informed consent document before being treated in the study
排除标准
- •Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
- •Any contraindications for oral surgical procedures
- •Current untreated periodontitis or gingivitis
- •Probing pocket depth of more than 4 mm at one of the adjacent teeth
- •Mucosal diseases (e.g. erosive lichen planus)
- •History of local irradiation therapy
- •Bone augmentation procedures if the procedure require healing time of more than 12 weeks after implant placement
- •Implants in adjacent position to planned implant
- •Severe bruxing or clenching habits
- •Heavy smokers: Patients who smoke more than 20 cigarettes per day
- •Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation.
- •Patients with inadequate oral hygiene or unmotivated for adequate home care
- •Secondary Exclusion Criteria at Implant Surgery:
- •Lack of primary stability of the implant
- •Inappropriate implant position to insert implants according to the prosthetic requirements.
- •Patients with augmentation procedures requiring more than 12 weeks healing time.
研究组 & 干预措施
Submerged healing
The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment
干预措施: Straumann Bone Level Implant (Device)
Trans-mucosal healing
The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment
干预措施: Straumann Bone Level Implant (Device)
结局指标
主要结局
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)
时间窗: Baseline and 6 months
The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.
次要结局
- Implant Survival Rate(12 months)
- Implant Survival Rate(6 months)