DRKS00027236招募中4 期
Immediate implant placement in molar extraction sockets using fully tapered tissue level implants: a randomized controlled post-market multinational clinical study - Immediate implant placement using fully tapered tissue level implants
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •Patients must have voluntarily signed the informed consent form before any study related procedures
- •- Patients must be a minimum of 18 years of age
- •- Periodontally healthy patients (no PPD greater than 4 mm except failing molar or PPD at implants higher than 6 mm)
- •- Patients who are in need of a molar extraction (failing tooth) of the maxilla or mandible and replacement with a dental implant
- •- Planned site for implant must have a natural tooth or implant mesially or distally in the adjacent tooth positions
- •- Patients must have an opposing tooth (natural teeth or implant, fixed or removable restorations) to the planned site
- •- Patients must be committed to the study and the required follow-up visits
排除标准
- •- Patients with a systemic disease that would preclude dental implant surgery
- •- Patients with any contraindications for oral surgical procedures
- •- Patients with mucosal diseases (e.g., erosive lichen planus) in the localized area around the study implant site
- •- Patients with a history of local irradiation therapy in the head/neck area
- •- Patients with any untreated endodontic lesions or untreated periodontal disease adjacent to the implant site
- •- Patients receiving, or having a history of receiving, intravenous or subcutaneous antiresorptive agents, such as bisphosphonates
- •- Patients with inadequate oral hygiene (PI higher than 30%) or who are unmotivated for adequate oral hygiene
- •- Patients who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
- •- Patients who are pregnant or intending to become pregnant during the duration of the study
- •- Patients who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day) or chew/dip tobacco
- •- Patients with confirmed alcoholism or known drug abuse (as per medical records)
- •- Patients who have undergone administration of any investigational device within 30 days of enrolment in the study
- •- Patients 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
研究者
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