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临床试验/NCT07642128
NCT07642128已完成不适用

Effect of Two Forms of Magnetic Attachments on Retention of Implant Retained Mandibular Over-Dentures Randomized Controlled Clinical Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 14 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
已完成
入组人数
14
试验地点
1

研究概览

简要总结

Aim of the Study The aim of this study is to compare between two forms of magnetic attachments in implant retained mandibular over-dentures.

详细描述

Complete edentulism of the mandible is frequently associated with compromised denture retention and stability, which may negatively affect mastication, comfort, and patient satisfaction. Mandibular implant-supported overdentures retained by magnetic attachments have been introduced as a reliable treatment option to improve prosthesis retention and function.

Different magnetic attachment designs are available, including flat and dome-shaped configurations. The geometry of magnetic attachments may influence retentive behavior, stress distribution, and overdenture stability during function. However, clinical evidence comparing the retention performance of these attachment designs remains limited.

This randomized clinical trial will include 14 completely edentulous patients aged 50-65 years. All participants will receive two implants placed in the canine regions of the mandible using a fully guided surgical protocol. After a 3-month healing period, patients will be randomly allocated into two equal groups according to the magnetic attachment design used. Group I will receive flat magnetic attachments, while Group II will receive dome-shaped magnetic attachments.

The primary outcome measure will be overdenture retention evaluated using a digital force gauge. Retention measurements will be performed at the time of overdenture loading (baseline), after 3 months of functional use, and after 6 months of functional use. The results will be used to determine whether magnetic attachment design influences the retention of mandibular implant-supported overdentures.

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
None

盲法说明

This is an open-label study. Participants and investigators are aware of the magnetic attachment design used. Outcome assessment is based on objective retention measurements obtained using a digital force gauge.

入排标准

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

入选标准

  • Completely edentulous mandible for at least 6 months.
  • Age between 50 and 65 years.
  • Adequate interforaminal bone volume for placement of two implants in the mandibular canine regions.
  • Angle Class I maxillomandibular relationship.
  • Medically fit patients capable of undergoing implant surgery.
  • Ability and willingness to comply with study visits and follow-up procedures.
  • Signed informed consent.

排除标准

  • Uncontrolled systemic diseases that may contraindicate implant surgery or affect osseointegration.
  • Uncontrolled diabetes mellitus.
  • Osteoporosis or metabolic bone disorders affecting implant healing.
  • Previous head and neck radiotherapy.
  • Presence of oral lesions or untreated oral pathology.
  • Temporomandibular joint disorders.
  • Parafunctional habits such as bruxism.
  • Inability to comply with study protocol or follow-up schedule.

研究者

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

Marwan Elnady

dentist

Ain Shams University

研究点 (1)

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