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临床试验/NCT06887595
NCT06887595已完成不适用

A Comparative Study of AI-Powered/Computer-Guided Versus Conventional Linear Micro-Perforation Split Approach for Treatment of Horizontal Mandibular Ridge Atrophy (A Randomized Clinical Trial)

Kafrelsheikh University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年3月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
ridge width

研究概览

简要总结

The traditional ridge split technique might be performed simultaneously with implant placement, resulting in a shortened treatment time. However, this approach has the potential for serious complications, including buccal bone fracture, prolonged pain or paresthesia, and loss of bone height. Linear Micro-Perforation Osteotomy (LMPO) has emerged as a less invasive alternative, promoting natural bone expansion through controlled micro-perforations in the cortical bone, allowing for ridge widening without extensive grafting. However, the precision required for LMPO can be difficult to achieve manually, especially in anatomically complex or narrow ridge areas, leading to variability in outcomes and potential risks such as bone fractures or inadequate expansion.Our study aims to evaluate the efficacy, clinical, and radiological outcomes of the flapless AI-powered/computer-guided LMPO ridge split/expansion technique compared to the traditional LMPO ridge split/expansion method for lateral ridge reconstruction of mandibular horizontal ridge deficiencies.

详细描述

In contemporary dentistry, the aim is to replace missing teeth with prosthetics or to remove diseased teeth from the patient and return them to normal in terms of shape, function, comfort, appearance, speech, and health. Why implant dentistry is different is the capacity to fulfill this objective despite atrophy, illness, or harm to the stomatognathic apparatus.

Implant-based dental rehabilitation of partly or completely edentulous areas has become a frequent procedure with consistent long-term outcomes in recent decades. Nevertheless, alveolar ridges are frequently impaired with horizontal inadequacy as a result of bone resorption, which has an impact on implant application.

The resorption of alveolar bone is a common sequelae of tooth loss and presents a clinical problem for implant placement. Implants must be placed with at least 1 mm of bone on the buccal and lingual aspects to maintain crestal bone levels.

Narrow edentulous ridges less than 5 mm wide present a challenge to the clinician for implant placement. Hence, lateral bone augmentation procedures are necessary to overcome maxillary and mandibular bone deficiencies. These procedures involve the use of bone augmentation, such as guided bone regeneration (GBR), bone block (autogenous or non-autogenous), and conventional onlay/inlay graft. Those procedures have many drawbacks such as longer healing time (6-9 months) for adequate bone regeneration before implant placement, the possibility of membrane exposure, an increased risk of infection, high cost, and rapid graft resorption; thus leading to inadequate bone regeneration or loss of the newly formed bone.

Based on previous knowledge, ridge split/expansion was introduced as an alternative to treat the width insufficiency of alveolar ridges with specific indications. The basic procedure includes a sagittal osteotomy in the center of the edentulous ridge, where the two cortical plates are expanded to increase the width and thereby simultaneous implant insertion with an appropriate diameter could be achieved.

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

入选标准

  • Patients presenting with narrow alveolar ridge that requires dental implantation.
  • Minimum bone width of 3 mm
  • Ridge width of not less than 3 mm in CBCT image
  • Minimum bone height of 10 mm
  • Proper inter-occlusal space
  • Perioperative cone beam CT scan image of the atrophic ridge

排除标准

  • • Uncontrolled diabetes.
  • Heavy smokers.
  • Current chemotherapy or radiotherapy.
  • Alcohol or drug abuse.
  • Pregnant women.
  • Active infection.
  • Inter-occlusal space not less than 7-8 mm.

研究组 & 干预措施

study group I

Experimental

ridge split and expansion with free-hand linear micro perforation osteotomy approach with simultaneous implant placement

干预措施: Free-hand linear micro perforation osteotomy and ridge splitting (Procedure)

study group II

Experimental

ridge split and expansion with AI-assisted/computer-guided (linear micro perforation osteotomy approach with simultaneous implant placement)

干预措施: AI-assisted/computer-guided linear micro perforation osteotomy and ridge splitting (Procedure)

结局指标

主要结局

ridge width

时间窗: 12-months

The width of the alveolar bone will be measured again using CBCT

次要结局

未报告次要终点

研究者

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

Walid Elamrousy

Assistant Professor of periodontology

Kafrelsheikh University

研究点 (2)

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