Artificial Intelligence-Assisted/Computer Guided Ridge Splitting for the Treatment of Horizontal Ridge Defects With Simultaneous Guided Implant Placement: Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- alveolar ridge width
研究概览
简要总结
Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided ridge splitting approach assisted by artificial intelligence versus conventional approach combined with simultaneous implant Placement.
详细描述
Ridge split technique is considered one of the successful horizontal bone augmentation procedures especially in maxilla for the management of horizontal ridge defects. This was adapted by Summers in 1994.
Guided implant surgery was used in dental implant surgery to achieve accuracy and an overall predictability. Successful guided implant workflow depends on 3-dimensional image acquisition and precise model fabrication.
Artificial intelligence application in implant dentistry has ushered in a new era of precision and efficiency demonstrating improved implant survival rates and patient satisfaction and enhance the integration of technologies with digital workflows.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The target population with inadequate bone volume for implant placement due to width insufficiency of maxillary anterior alveolar ridges.
- •Age ranges from 18-40 years of both sexes.
- •No gender restrictions were considered for initial screening.
- •Absence of any complicating systemic condition that may contraindicate surgical procedures and implant placement.
- •Adequate oral hygiene.
- •Eligible participants should present good general health and agree to random assignment to any of the two parallel study groups.
- •Participants had minimum 3 months as post extraction healing period and horizontal maxillary anterior ridge defects with at least bone width of 3 mm and bone height of 13 mm.
排除标准
- •Vertical ridge defect.
- •Undercut on the labial/buccal side.
- •Thick cortical bone without cancellous bone inside.
- •Uncontrolled systematic disorders as, diabetes mellitus, uncontrolled periodontal disease, history of head and neck radiotherapy, smokers, pregnancy, noncompliant patients, allergy to the used medications, uncooperative individuals or those unable to attend the study follow-up appointments.
研究组 & 干预措施
control group
conventional ridge splitting with conventional simultaneous implant placement.
干预措施: free-hand ridge splitting (Procedure)
study group
computer guided ridge splitting assisted by artificial intelligence with simultaneous computer guided implant placement.
干预措施: AI/guided ridge splitting (Procedure)
结局指标
主要结局
alveolar ridge width
时间窗: 24-month.
CBCT will have taken immediately after surgery, at 6 and 9 months postoperatively to evaluate ridge width using OnDemand3D™ App-3D CBCT software. The alveolar ridge width will be measured buccolingually in axial view 2 mm apical to the implant collar margin.
次要结局
- vertical bone height(24-months)
研究者
Walid Elamrousy
Assistant Professor of periodontology
Kafrelsheikh University