Evaluation of the Crestal Bone Expansion Obtained With the Magnetic Mallet® During the Preparation of the Implant Site
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- bone thickness at T0
研究概览
简要总结
The purpose of the study is to evaluate the use of a magnetodynamic instrument (Magnetic Mallet®, Metaergonomica, Turbigo, Italy) to perform a horizontal bone expansion in edentulous sites that need to be rehabilitated with a dental implant.
详细描述
From October 2019 to May 2022, a sample of 15 patients, 11 men and 4 women, age between 39 and 78 years, was analyzed. A total of 18 conical-shaped implants with a diameter of 3.80 mm and a length between 10 and 11.5 mm were inserted in the maxillary region in the area between the lateral incisor and the first upper molar. The patients were treated by two different surgeons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with maxillary mono-edentulism between the lateral incisor and the first upper molar with a bone crest measuring between 4-6 mm;
- •Insertion of conical implants with dimensions 3.80 x > 10 mm;
- •Correct occlusal relationships between upper and lower jaw;
- •Patients willing to cooperate and follow the instructions given by the clinicians.
排除标准
- •Smokers > 15 cigarettes per day;
- •Patients with systemic diseases;
- •Irradiation to the head/neck region within 12 months prior to surgery;
- •Pregnancy or breastfeeding;
- •Poor oral hygiene and lack of motivation to return for checkups;
- •Edentulous area for less than 1 year;
- •Edentulousness of the lower jaw.
结局指标
主要结局
bone thickness at T0
时间窗: Before the surgery
Thickness of the bone before the surgery measured with cbct and a parodontal probe
bone thickness at T2
时间窗: Immediately after the implant insertion
Thickness of the bone after implant insertion measured with a parodontal probe
bone thickness at T1
时间窗: Immediately after the implant site preparation
Thickness of the bone after the use of Magnetic Mallet measured with a parodontal probe
次要结局
- bone thickness at T3(3 months)
研究者
Paolo Pesce
Prof
Universita degli Studi di Genova