跳至主要内容
临床试验/NCT07369583
NCT07369583已完成不适用

Monolithic Zirconia Full-Arch Rehabilitation Using a Motion-Integrated Digital Workflow Combining M-4 and All-on-4 Protocols: A Clinical Report

Menoufia University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月1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
20
试验地点
1
主要终点
Marginal bone loss

研究概览

简要总结

20 edentulous patients presented for full-arch rehabilitation and was managed using a motion-integrated, fully digital workflow that combined the M-4 protocol in the maxilla with the All-on-4 concept in the mandible. Dual-scan CBCT and facial scans enabled prosthetically driven planning, while stackable and mucosa-supported surgical guides facilitated precise implant placement. Real-time jaw-motion data were incorporated into the design process to individualize occlusion, and definitive monolithic zirconia prostheses were fabricated and delivered on titanium multi-unit abutments using Rosen screws.

详细描述

20 edentulous patients sought comprehensive full-arch rehabilitation to improve function, esthetics, and overall oral comfort. Management was performed using a fully digital, motion-integrated workflow that strategically combined two established implant protocols: the M-4 technique in the maxilla to maximize anterior anchorage in areas of limited bone volume, and the All-on-4 concept in the mandible to provide stable posterior support with tilted distal implants. Treatment planning began with dual-scan CBCT imaging and high-resolution facial scans, allowing accurate alignment of skeletal, dental, and soft-tissue datasets for prosthetically driven virtual design. A stackable guide system was employed in the maxilla to sequentially guide fixation, osteotomy preparation, and implant placement, whereas a mucosa-supported guide was used in the mandible to ensure stable positioning on the residual ridge. During the prosthetic phase, real-time mandibular motion was recorded and integrated into the CAD software to refine occlusal morphology according to the patient's functional movements. Definitive monolithic zirconia full-arch prostheses were then digitally fabricated and secured to titanium multi-unit abutments using Rosen screws, providing a rigid, precise, and metal-free restorative solution. This coordinated workflow addressed both functional and esthetic demands, enabling an efficient, patient-specific approach to immediate full-arch rehabilitation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Months 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 40-65 years with edentulism in one or both arches.
  • Adequate bone volume in the anterior maxilla for M-4 protocol and mandible for All-on-4 placement.
  • Willingness to undergo full-arch implant rehabilitation using a digital workflow.
  • Ability to provide informed consent and comply with study procedures.

排除标准

  • Systemic conditions contraindicating implant surgery (e.g., uncontrolled diabetes, immunosuppression).
  • Active oral infections or untreated periodontal disease.
  • Heavy smokers (>10 cigarettes/day) or substance abuse.
  • History of head and neck radiation therapy or bisphosphonate use.
  • Pregnancy or breastfeeding.

研究组 & 干预措施

Motion-integrated digital full-arch rehabilitation (M-4 maxilla / All-on-4 mandible)

Experimental

A fully digital, motion-integrated implant rehabilitation protocol combining the M-4 concept in the maxilla and the All-on-4 concept in the mandible. The arm included prosthetically driven planning using CBCT, intraoral and facial scanning, stackable and mucosa-supported surgical guides, immediate loading, jaw-motion tracking-guided occlusal design, and definitive monolithic zirconia full-arch prostheses connected to titanium multi-unit abutments.

干预措施: Motion-Integrated, Fully Digital Full-Arch Implant Rehabilitation Combining Maxillary M-4 and Mandibular All-on-4 Protocols with Monolithic Zirconia Prostheses (Device)

结局指标

主要结局

Marginal bone loss

时间窗: 12 months post-implant placement

Marginal bone loss will be evaluated using periapical radiographs

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

Mohammed El-Sawy

Clinical Professor and principle investigator

Menoufia University

研究点 (1)

Loading locations...

相似试验