Evaluation of Computer Guided Placement of Zygomatic Implants for Reconstruction of Atrophic Maxilla Utilizing Two Different Approaches: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pain by Visual Analogue Scale (VAS)
研究概览
简要总结
Evaluation of computer guided placement of Zygomatic implants utilizing intra sinus versus extra sinus surgical approach for the reconstruction of atrophic maxilla. The expected benefit from the current study is to select the most suitable approach for Zygomatic implant placement with the least postoperative complications
详细描述
During the last ten years, there has been an increase in the number of edentulous patients looking for and seeking out rehabilitation. Formerly, individuals with edentulous maxilla and mandibles were rehabilitated with removable complete dentures, but it was associated with poor patients' satisfaction.
Alveolar bone atrophy results from loss of bony support due to the physiological process that naturally takes place after tooth loss, especially in the upper arch. Due to its shape and structure, the maxilla is an extremely challenging arch to reconstruct with dental implants.
Oral and Maxillofacial surgeons began utilizing alternative methods to replace missing teeth with osseointegrated dental implants in atrophic maxilla. As a result, different methods were developed for handling of this issue, including tilted implants, sinus elevation, the use of Pterygoid implants, the use of short implants and Zygomatic implants.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Each patient will be given a code by the researcher and the observers will be blind to which group this case belong. Patients, radiographic outcome assessor and statistician will be blinded.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored by other type of treatment
- •Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of 2 conventional implants.
- •Lacking posterior maxillary bone support due to significant sinus pneumatistion
- •Good systemic health (ASA score I-II)
- •Highly motivated patients.
排除标准
- •Patient not willing to give his/her informed consent.
- •Patients with systemic disease that did not permit the surgical procedure (including general anaesthesia).
- •Patients with uncontrolled diabetes or under bisphosphonate therapy.
- •Heavy smoker.(> 20 cigarettes daily)
- •Patient with psychiatric problems, severe bruxism or other parafunctional habits.
- •Acute sinusitis.
- •Malignancy or pathology in Maxilla or Zygoma.
研究组 & 干预措施
Computer guided intra sinus approach for Zygomatic implant placement.
After reflection of mucoperiosteal flap then the non-working tip of the coarse diamond bur will be inserted till the initial marking point and further preparation of osteotomy site will be performed along the lateral wall of maxillary sinus then sinus membrane will be reflected gently to get easily access for 3.5 mm drill or 4-4.5 mm diameter Zygomatic implant. The surgical stent will be inserted inside the patient's mouth; it will be adapted and held in place by the anchoring screws to Zygoma and osteotomy will progressively widened by using standard 2.9 mm diameter drill and 3.5 mm twist diameter drill.
Depth indicator will be used to determine the length of Zygomatic implant. Zygomatic implant will be placed.
The platform of Zygomatic implant will be emerged over and close to the top of the crest of the residual alveolar ridge near to first molar region. Closure will done with 3-0 silk suture.
干预措施: Zygomatic implants (Procedure)
Computer guided extra sinus approach for Zygomatic implant placement.
After adequate exposure of surgical The surgical stent will inserted inside the patient's mouth; it will adapted and held in place by the anchoring screws to Zygoma and osteotomy will progressively widened by using standard 2.9 mm diameter drill and 3.5 mm twist diameter drill.
Depth indicator will be used to determine the length of Zygomatic implant. Zygomatic implant that will placed.
The platform of Zygomatic implant will be emerged over and close to the top of the crest of the residual alveolar ridge near to first molar region. Closure will done with 3-0 silk suture.
干预措施: Zygomatic implants (Procedure)
结局指标
主要结局
Pain by Visual Analogue Scale (VAS)
时间窗: operation day and first week
1-10
次要结局
- Crestal bone loss around zygomatic implants(after 6 months)
- Post operative complications(1st week , first month , third month and sixth month)
研究者
Abdulrahman Adnan Aldakka
Master's degree candidate
Cairo University