Accuracy of Completely Versus Partially Limiting Computer Guided Zygomatic Implant Placement. a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Implant position
研究概览
简要总结
The aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.
详细描述
According to World Oral Health Organization (WHO), losing teeth and arch edentulism is the result of a life long history of oral diseases like advanced dental caries and severe periodontal disease. Complete tooth loss estimated global average prevalence is 7% among people aged 20 years and 23% among people aged 60 years or older. Tooth loss lead to bone resorption in all direction.
Non-grafting solutions have been developed to reduce risks, morbidity, and treatment time. These types of treatment are often preferred by patients, considering that they may minimize total treatment time and have less morbidity than staged procedures of grafting solutions.One of non-grafting solutions is the zygomatic implants.
Zygomatic implants have shown improved clinical results compared with bone grafting in compromised maxillary bone.But the same as any surgical procedure, placing zygomatic implants has potential complication, such as: oro-antral communication, paresthesia or altered sensation of the infra orbital nerve also penetration of the orbital cavity may occur. In order to achieve the optimal position of zygomatic implant, computer-based planning has been introduced with the use of surgical guides.
Surgical guides are classified according to design concepts for fabrication of surgical guide to non-limiting, partially limiting design and complete limiting. In partially limiting design,the first drill is used then the surgical guide is removed and the osteotomy and implant placement are completed in freehand while in complete limiting design all the instruments used in surgical procedure during implant placement are restricted.
In literature, there is low evidence of using partially guided surgery for zygomatic implant and also of comparing the two designs with each other. the aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.
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 (Outcomes Assessor)
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 older than 18 years.
- •Patients with severe alveolar bone atrophy in posterior maxilla (residual alveolar crest less than 4 mm in height, in the area immediately distal to the canine pillar).
排除标准
- •Patients with systemic conditions contra-indicating general anesthesia.
- •Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
- •Patients with acute maxillary sinus infection or maxillary sinus cyst.
- •Restricted mouth opening (less than 3 cm inter-arch distance anteriorly).
研究组 & 干预措施
completely limiting computer generated surgical three-dimensional guide
patients in this group will receive zygomatic implant placed in a completely fully guided technique using surgical guide,keys and sleeves.
干预措施: completely limiting computer generated surgical three-dimensional guide (Procedure)
Partially limiting computer generated surgical three-dimensional guide
patients in this group will receive zygomatic implant placed in a partially guided technique using surgical guide.The first drill only will be used with the guide then the guide will be removed and the whole procedure with the remaining drills will be completed in a free hand technique.
干预措施: Partially limiting computer generated surgical three-dimensional guide (Procedure)
结局指标
主要结局
Implant position
时间窗: one week after the surgery.
Comparing the position of implant post-operatively with the virtual planning pre-operatively.
次要结局
- Surgery duration(from the start of surgery to the completion of surgery.)
研究者
Mohamed Kamal Hassan Ghallab
Teaching assistant in the Department of Oral and Maxillofacial Surgery
Fayoum University