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临床试验/NCT07353619
NCT07353619招募中不适用

All-on-X (Full-arch Implant-supported Rehabilitation) Stackable Surgical Guides for Maxillary Terminal Dentition: a 2-year Retrospective Analysis

Menoufia University0 个研究点目标入组 40 人开始时间: 2024年1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

研究概览

简要总结

This retrospective study will evaluate the clinical performance of maxillary All-on-X(full-arch implant-supported rehabilitation) implant rehabilitation using stackable guided surgery and immediate loading. Implant survival and peri-implant outcomes will be assessed over a 2-year follow-up, with regression analysis will be used to investigate the influence of surgical and prosthetic variables, including basal seating guide design.

详细描述

This study is a retrospective analysis of data derived from a prospectively maintained clinical database evaluating the clinical performance of maxillary All-on-X implant rehabilitation using a fully digital stackable guided surgery protocol with immediate loading.

Consecutive patients presenting with terminal maxillary dentition were treated with a maxillary All-on-6 implant-supported complete fixed dental prosthesis (ISCFDP) using a prosthetically driven digital workflow. Implant planning was performed using three-dimensional imaging and dedicated implant planning software, allowing for virtual determination of implant number, position, angulation, and depth in relation to the planned prosthesis. Stackable surgical guides were designed and fabricated to allow guided bone reduction when indicated, followed by fully guided implant placement.

All implants were placed under local anesthesia using a standardized surgical protocol. Implants achieving a minimum insertion torque of 35 Ncm were immediately loaded with a screw-retained provisional fixed prosthesis on multi-unit abutments. Occlusal contacts were minimized during the healing phase to reduce functional loading. Patients were followed according to a predefined clinical and radiographic follow-up schedule for a minimum period of two years.

The primary outcome of the study will be implant survival at 6 months after placement. Secondary outcomes will include peri-implant clinical parameters (plaque index, bleeding on probing, and probing depth), marginal bone level changes which will be assessed on standardized periapical radiographs at prosthesis delivery, 1-year, and 2-year follow-up visits, and implant success according to established criteria.

研究设计

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

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

  • Adult patients presenting with terminal dentition of the maxillary arch
  • Rehabilitation with a maxillary All-on-6 implant-supported complete fixed dental prosthesis
  • Treatment performed using a fully digital stackable guided surgery workflow
  • Immediate loading with a provisional fixed prosthesis
  • Availability of complete clinical and radiographic records
  • Minimum follow-up period of 2 years
  • Prosthetic design classified as (Fixed prosthesis) FP-1 or FP-2 according to Misch classification

排除标准

  • Uncontrolled systemic conditions contraindicating implant surgery
  • History of head and neck radiotherapy
  • Presence of untreated periodontal or peri-implant infection at the time of surgery
  • Incomplete or missing clinical or radiographic records
  • Cases requiring simultaneous bone grafting procedures
  • Severe maxillary atrophy (Cawood and Howell Class III-V)
  • Cases requiring FP-3 prosthetic design
  • Rehabilitation performed without guided surgery or without immediate loading

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

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