Evaluation of Implant Stability Changes in Sites Prepared with Different Osseodensification Techniques: a Prospective Observational Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Implant primary stability
研究概览
简要总结
The goal of this observational study is to compare, within a cohort of patients requiring rehabilitation in two different sites of the premolar area in the upper maxilla, the primary and secondary stability of implants placed in sites prepared using a magnetic mallet and osseodensification burs.
详细描述
The primary outcome measures included implant primary stability, assessed through insertion torque and ISQ (Implant Stability Quotient).
Secondary outcome measures were implant secondary stability pattern during the initial 90 days post-implant placement (ISQ), implant survival after one year, the time required for each implant site preparation and any complications or adverse events.
As an additional outcome of this study, we aimed to assess whether there was a relationship between the instrument utilized for implant site preparation and early marginal bone loss. Marginal bone levels were measured at three time points: immediately after surgery (T0), upon delivery of prosthetic rehabilitation (T1), and after one year of loading (T2). The distance between implant platform and bone crest was measured at each time interval, on both mesial and distal aspects of the implant. A positive value was assigned when the bone crest was coronal to the implant platform, whereas a negative value was assigned when the bone crest was apical to the implant platform.
Study design: Observational study of a prospective non-profit cohort.
Study population: The study will be conducted in an outpatient hospital setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age older than 18 years old;
- •Indication for an implant-supported rehabilitation in the upper premolar / first molar areas;
- •The area in which the implants will be placed must have had at least 6 months of healing;
- •No use of grafts or bone substitutes following tooth extraction;
- •Bone volume measuring at least 10 mm in height and 6 mm in width;
- •In case of two adjacent implants the distance between the natural teeth must be at least 14 mm, composed by twice the width of each implant (4 mm), the distance between them (at least 3 mm) and twice the distance between each teeth (at least 1,5 mm)
- •Bone quality belonging to class D3 or D4, following Misch classification
- •Absence or decision to not wear a removable prosthesis during the healing period;
- •Patients with good and stable oral hygiene;
- •Signed informed consent form.
排除标准
- •Acute myocardial infarction within the previous six months;
- •Uncontrolled bleeding disorders;
- •Uncontrolled diabetes (HBA1c > 7.5%);
- •Radiotherapy in the head-neck area in the previous 48 months;
- •Immunocompromised patients (es. AIDS / chemotherapy);
- •Current or previous treatment with antiresorptive drugs via intravenous injection;
- •Psychological or psychiatric disease;
- •Alcohol and /or drugs abuse;
- •Heavy smokers (more than 10 cigarettes / day);
- •Plaque index >20% and/or bleeding on probing >10%
- •Pregnant or breastfeeding patients;
- •Patients refusing to participate in follow-up checks.
结局指标
主要结局
Implant primary stability
时间窗: At implant insertion
Resonance frequency
次要结局
- Implant secondary stability(90 days after implant insertion)
- Surgical time(The measurement began when the first pilot osteotome or drill was used and ended when the implant was placed.)