Wedge Implant for Minimally Invasive Treatment of Narrow Crests: a Prospective Multi-center Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- implant survival rate
研究概览
简要总结
This study was designed as a multicentric prospective clinical trial to assess the clinical, biological and patient's perceived success of new wedge-shaped dental implants inserted in narrow ridges.
详细描述
Due to the loss of dental elements, the bone crest undergoes a significant remodeling. Bone resorption begins immediately after dental extraction with a 40-60% reduction in horizontal and vertical direction of the alveolar ridge during the first 2 years. The most significant bone loss after tooth extraction occurs within the first 3 months, although modeling and remodeling of the alveoli have a great variability of time: bone structure and organization may not be complete even 24 weeks after dental extraction.
It is now known that crestal remodeling is closely related to the disappearance of the bundle bone, which is more representative of the buccal appearance of the alveolus. Its disappearance, especially in thin periodontal biotopes, can lead to significant recessions of hard and soft tissues.
Moreover, with a variable percentage, in many patients, crestal resorption continues over time due to a combination of factors involved: anatomical, metabolic and mechanical. Among these, the use of removable total or partial dentures can play an important role in accelerating the resurfacing process.
With these premises, it is common to find patients with atrophic crests when processing plans that provide implant support prosthetic rehabilitation.
A crestal bone thickness of at least 6 mm in the buco-lingual sense is considered sufficient to safely place a plant with a diameter of 4 mm. But when the width is lower, a variety of procedures and techniques have been proposed in literature that allow recreate the volumes needed for implant placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •indications for prosthetic rehabilitation supported by implants in the upper or lower arch, based on accurate diagnosis and treatment planning;
- •the bone crest must be completely healed (at least six months after the tooth loss);
- •residual bone ridge width between 3.5 and 5 mm, at least 3 mm in apical direction;
- •presence of at least 10 mm bone height available for implant placement;
- •age of the patient> 18 years;
- •The patient must not carry any removable prosthesis on the treated area;
- •the patient must be able to follow the protocol of study;
- •informed written consent
排除标准
- •acute myocardial infarction over the last 2 months;
- •uncontrolled coagulation disorders;
- •unmanaged diabetes (HBA1c> 7.5);
- •radiotherapy to the head area in the last 24 months;
- •immunocompromised, HIV positive or chemotherapy patients over the past 5 years;
- •present or past treatment with intravenous bisphosphonates;
- •psychological or psychiatric problems;
- •abuse of alcohol or drugs;
- •uncontrolled periodontal disease
结局指标
主要结局
implant survival rate
时间窗: 1 year after surgery
health of the inserted implants
次要结局
- implant stability 4 months(4 months after surgery)
- implant stability 6 months(6 months after surgery)
- surgical procedure evaluation(1 hour after surgery)
- implant stability 1 month(1 month after surgery)
- implant stability 2 months(2 months after surgery)
- implant stability 5 months(5 months after surgery)
- implant stability 3 months(3 months after surgery)
- implant stability 1 year(1 year after surgery)
- implant stability 14(14 days after surgery)
- implant stability 3 years(3 years after surgery)
- implant stability 5 years(5 years after surgery)
研究者
Mr. Claudio Stacchi, DDS, MSc
President of the Academy
International Piezosurgery Academy