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临床试验/NCT07196943
NCT07196943招募中不适用

Outcomes of Implant-Supported Equator Overdentures Following Fully Guided Static Implant Surgery: A Prospective Study

Menoufia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Implant Survival Rate

研究概览

简要总结

This prospective clinical study evaluated the 3-year performance of mandibular implant-supported overdentures (IODs) placed using a fully guided static computer-assisted implant surgery (CAIS) protocol. Primary outcomes included implant survival, peri-implant soft tissue health, and marginal bone loss. Findings provide evidence for the predictability of digital surgical workflows in removable prosthodontics.

详细描述

Edentulism remains a prevalent global health concern that compromises oral function, esthetics, and quality of life. While conventional complete dentures are widely used, their limitations in mandibular stability often reduce patient satisfaction. Implant-supported overdentures (IODs) offer superior retention and function, but their long-term success depends heavily on precise implant placement.

Computer-assisted implant surgery (CAIS), particularly static fully guided protocols, has been shown to enhance surgical accuracy in fixed prosthodontics. However, evidence for their application in removable prosthodontics remains limited, despite the anatomical and prosthetic challenges often encountered in overdenture cases.

This prospective clinical study was designed to assess the 3-year clinical performance of mandibular IODs placed via a fully guided static CAIS workflow. Outcomes included implant survival, peri-implant soft tissue health, and marginal bone changes. The results provide valuable clinical insight into the role of digital surgical protocols in improving predictability and long-term success of overdenture rehabilitation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Completely edentulous mandible requiring implant-supported overdenture rehabilitation
  • Adequate bone volume to accommodate four implants in a quadrilateral configuration, confirmed by cone-beam computed tomography (CBCT)
  • Age between 40 and 75 years
  • Good general health with no systemic contraindications to implant surgery
  • Willingness and ability to provide informed consent
  • Commitment to attend all scheduled follow-up visits over the 3-year study period

排除标准

  • Uncontrolled systemic diseases (e.g., diabetes mellitus, osteoporosis)
  • History of radiotherapy in the head and neck region
  • Untreated oral infections or severe periodontal disease
  • Poor oral hygiene or inability to comply with maintenance protocols
  • Heavy smoking (>10 cigarettes/day) or alcohol abuse
  • Known allergy or intolerance to materials or medications used in the study

结局指标

主要结局

Implant Survival Rate

时间窗: From prosthesis delivery to 36 months post-loading

Defined as the percentage of implants remaining in function without mobility, pain, infection, or need for removal during the study period. Survival will be evaluated clinically at each follow-up visit.

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

Dr

Menoufia University

研究点 (1)

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