Marginal Bone Loss in Implants Placed in Bone Level and Tissue Level
概览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Torque
概览
简要总结
It is a prospective clinical study to compare two implants of the same brand of a similar design for implantation [either at the bone tissue level or at the soft tissue level], in order to evaluate the marginal bone loss of each dental implant in mm. 96 patients will be analyzed (an expected N of 48 per group, hoping to reach 100 implants per arm).
详细描述
it is a study to evualte the marginal bone loss in bone level and tissue level dental implants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
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
- •Patients of both sexes, over 18 years of age, who need dental implant placement for prosthetic rehabilitation. Whether partially or completely in both the maxilla and the mandible.
- •Patients with residual alveolar ridge with at least 8 mm of bone height and 4 mm of width.
- •Patients must have the ability to understand and decide when voluntarily signing the informed consent before carrying out any intervention related to the study.
- •Patients who, after being informed about the objectives and procedures of the research, agree will sign the informed consent form. And they are ready to carry out the different study visits.
排除标准
- •Patients with uncontrolled systemic diseases (ASA ≥ III).
- •Patients who do not have 8mm bone height and/or 4mm width
- •Patients who require bone regeneration
- •Patients with severe periodontal disease or acute pericoronitis.
- •Pregnant and breastfeeding women.
- •Patients with Deficient or Inadequate Oral Hygiene.
- •Patients with severe bruxism.
- •Patients taking bisphosphonates or other antiresority medications.
- •Smoker of more than 10 cigarettes/day.
- •Patients with uncontrolled diabetes mellitus.
研究组 & 干预措施
Bone Level
Placement of a bone-level dental implant. The implant-abutment interface is at the level of the alveolar bone crest.
干预措施: Dental implant placement (Procedure)
Tissue Level
Placement of a tissue-level dental implant. The implant-abutment interface is located supracrestally, at the level of the soft tissue.
干预措施: Dental implant placement (Procedure)
结局指标
主要结局
Torque
时间窗: up to 24 weeks
N·cm
marginal bone loss
时间窗: 6 months
mm
次要结局
未报告次要终点
研究者
José López Lopez
Director
University of Barcelona