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临床试验/NCT07256730
NCT07256730进行中(未招募)不适用

Comparative Study Between Artificial Intelligence-Assisted/Computer-Guided Versus Conventional Ridge Splitting Utilizing Electromagnetic Mallet for Reconstruction of Horizontal Ridge Defects: A Randomized Controlled Clinical Study

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年8月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
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

The current trial aims to assess the efficacy of utilizing the electromagnetic mallet either by AI-assisted digital workflow or by the conventional freehand approach for reconstruction of horizontal ridge defects utilizing the ridge-split and expansion technique.

详细描述

Dental implants are a durable and long-term choice for tooth replacement to provide both functional and aesthetic benefits. However, successful implantation is critical, as it needs a sufficient amount of bone to maintain an ideal implant pathway and avoid vital structures. Vertical and horizontal ridge defects might occur after tooth extraction.

The pattern of alveolar ridge defect after extraction is classified according to the Cologne Classification into horizontal, vertical, combination, and sinus defects. mild (up to 4 mm), moderate (4-8 mm), and significant (over 8 mm) atrophy.

Successful implant placement is difficult to maintain with insufficient bone height and width. Many surgical techniques were introduced for the horizontally collapsed ridges, such as ridge augmentation, block graft, guided bone regeneration, and onlay graft. But these techniques need a long period of time for reconstruction, and an additional surgery is required for delayed implant placement.

Among these techniques, the ridge-splitting technique was performed for treating horizontally collapsed ridges by means of splitting the deficient ridge followed by ridge expansion to accommodate simultaneous implant placement.

The concept of the ridge-splitting technique is to make a self-space-making defect. The ridge-splitting technique was introduced by Tatum Jr. in 1986 and reintroduced in 1990 by Scipioni et al. In 1994, the technique was adapted by Summers, who utilized the viscoelastic properties of bone by applying pressure in-between buccal and lingual cortical bones using Summers osteotome to increase the width of the bone.

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 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 to 40 years of both sexes.
  • •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 a minimum 3-month post-extraction healing period and a horizontal defect in the maxillary esthetic zone with at least a bone width of 3 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

Freehand spit

Experimental

conventional ridge splitting with conventional simultaneous implant placement

干预措施: free-hand ridge splitting (Procedure)

computer-guided split

Experimental

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 months

CBCT will have taken immediately after surgery and at 6, 12 and 24months postoperatively

次要结局

  • vertical bone height(24months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Walid Elamrousy

Assistant Professor

Kafrelsheikh University

研究点 (1)

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