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临床试验/NCT05675566
NCT05675566已完成不适用

Investigation of Time-Dependent Change of Retention Force of Mandibular Implant Overdenture and Evaluation of Patient Satisfaction: A Clinical Follow-up Study

Marmara University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Change in retention force

研究概览

简要总结

This descriptive longitudinal study aimed to investigate the retention force of implant-supported overdentures applied to edentulous individuals at Marmara University Faculty of Dentistry, examine the retention force and its time-dependent change, and evaluate patient satisfaction.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50-65 years old,
  • Volunteer to participate in the study,
  • Upper edentulous jaw with full denture, lower edentulous jaw with two-implant overdenture

排除标准

  • Pregnant or lactating women
  • Those who do not want to sign the consent form,
  • Patients with a history of malignancy, radiotherapy, or chemotherapy
  • Patients whose maxilla was rehabilitated with implant overdenture
  • More than 2 implants for lower jaw implant overdenture

结局指标

主要结局

Change in retention force

时间窗: 6 months

The retention of a complete implant overdenture prosthesis is defined as the minimum retention force (N) required to separate the male part of the attachment from the female part. The retention strength will be measured 3 times with a force gauge that allows the application of the retention force perpendicular to the occlusal plane of the prosthesis and parallel to the long axis of the implant, and the values will be averaged with a digital dynamometer. As the measurement value increases, it is concluded that the retention of the prosthesis increases. The measurements will be recorded on the 'Patient Measurement Card' at each control session. The retention of the implanted complete denture will be measured at the time of delivery of the implant overdenture to the patient and at the control sessions 1 week, 1 month, 3 months, and 6 months after the patient start to use the denture.

次要结局

  • Change in patient satisfaction(6 months)

研究者

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

Ferit Bayram

Assist. Prof.

Marmara University

研究点 (1)

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