Accuracy of Trephination-based Versus Drilling-based Guided Dental Implant Placement: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Angular deviation.
研究概览
简要总结
This study will be initiated to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol.
详细描述
This study will be conducted to compare the accuracy of implant placement using the guided trephination drilling protocol and the guided conventional drilling protocol.
the patients with a single missing tooth will be assigned to one group ( trephination drilling / conventional drilling ).the preoperative virtual planning and fabrication of a surgical guide will be made for each patient. after implant placement according to each group, postoperative (CBCT ) will be performed to compare the virtual implant position and the actual implant position.
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)
盲法说明
the outcome assessor is not involved in the study. he doesn't know the type of intervention.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single missing maxillary premolar or molar tooth.
- •Both genders aged from 20-50 years.
- •Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire. (Pendleton et al,.2004)
- •Mesio-distal space ≥ 7 mm.
- •Bone width in bucco-lingual direction ≥ 6 mm.
- •Uniform alveolar ridge with no undercuts.
- •Present mesial and distal sound neighboring teeth.
- •At least 4 natural remaining teeth on the same arch.
- •Mouth opening at least 30 mm.
排除标准
- •1) Pregnant and lactating females. 2) Smokers. 3) Poor oral hygiene. 4) Vulnerable groups of patients' e.g. (handicapped patients).
研究组 & 干预措施
guided trephination-based protocol
The drilling process will be performed by guided trephination protocol.
- An appropriate trephine drill (Helmut Zepf Medizintechnik GmbH, Germany) will be used to create an initial osteotomy.
- The guide will be removed, and the depth and angulation of this initial osteotomy will be evaluated.
- The final drill of the chosen implant system will be used to complete the osteotomy.
- The implant (NeoBiotech Implant System, Neobiotech Co. Ltd. Korea) then will be placed freehand in a conventional manner.
干预措施: guided trephination-based drilling protocol (Procedure)
guided conventional drilling-based protocol
The drilling process will be performed by a guided conventional drilling protocol.
- Drilling (Neo NaviGuide System - Neobiotech Co. Ltd. Korea) will be performed throughout the guiding sleeve from the first drill to the final drill.
- The guide will be removed.
- The implant (NeoBiotech Implant System, Neobiotech Co. Ltd. Korea) then will be placed freehand in a conventional manner.
干预措施: guided Conventional drilling-based protocol (Procedure)
结局指标
主要结局
Angular deviation.
时间窗: immediately after the intervention
measure the Angular deviation of the implant between the virtual planning position and the actual implant position
Horizontal deviation at apex of the implant.
时间窗: immediately after the intervention
measure the Horizontal deviation at apex of the implant between the virtual planning position and the actual implant position
•Horizontal deviation at implant shoulder.
时间窗: immediately after the intervention
measure the Horizontal deviation at the implant shoulder between the virtual planning position and the actual implant position
次要结局
- The duration of the surgery(during the surgery)
- Satisfaction assessed by the Visual Analogue Scale(immediately after the intervention)
研究者
Mohammed Ramadan
Principal investigator
Ain Shams University