Immediate Implant Placement: a Clinical and Radiographic Study on Hard and Soft Tissues Retraction at One Year.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Soft tissue change by superimposing surface intraoral scans between 0 and 12 months using 3d slicer software
研究概览
简要总结
This project consists of placing dental implants at extraction sites. Bone drilling and implant placement are performed using the flapless method with the use of a surgical guide allowing guided surgery. After implant placement, temporary teeth are immediately made and placed on the implants to guide the gingival contour.
Bone and soft tissue retraction at the implanted sites are measured radiographically and digitally using surface scan superimposition over a 12-month period.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Absence of systemic or osseous disease that may impair peri-implant healing
- •Age ≥ 21 years
- •Acceptable oral hygiene
- •Presence of both adjacent teeth
- •Absence of acute infection in the treated area
- •Absence of periodontal pockets > 3mm at the concerned site
- •Absence of pre-operative defect at the buccal bone wall (dehiscence or fenestration)
- •Per-operative integrity of the osseous and gingival structures (during tooth extraction)
- •Light or non-smoker (<10 cigarettes per day)
排除标准
- •Myocardial infarction within the past 6 months.
- •Poorly controlled diabetes (HBA1c > 7.5%).
- •Coagulation disorders.
- •Radiotherapy to the head/neck area within the past two years.
- •Present or past treatment with intravenous bisphosphonates.
- •Immunocompromised patients.
- •Psychological or psychiatric problems.
- •Alcohol or drug abuse.
- •Poor oral hygiene and motivation (full mouth plaque score > 30% and/or full mouth bleeding score > 20%).
- •Uncontrolled periodontal disease.
结局指标
主要结局
Soft tissue change by superimposing surface intraoral scans between 0 and 12 months using 3d slicer software
时间窗: 12 months
Soft Tissue profil retraction after immediate implant placement using 2 different bone substitutes by superimposing STL files between 0 and 12 monts using 3d slicer software
Hard tissue change by superimposing CBCT scans between 0 and 12 months using 3d slicer software
时间窗: 12 months
Buccal bone profil retraction after immediate implant placement using 2 different bone substitutes by comparing CBCT Dicom files at 0 and 12 months using 3d slicer software
次要结局
未报告次要终点
研究者
Christian Makary
Professor
Saint-Joseph University