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Retention of Dome and Flat Magnetic Attachments in Mandibular Implant Overdentures Randomized Controlled Clinical Trial

2026年6月7日 更新者:Marwan Elnady、Ain Shams University

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

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

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

14

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Cairo、埃及
        • Faculty of dentistry, Ain shams university

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Flat Magnetic Attachment Group
Participants received mandibular implant-supported overdentures retained by flat magnetic attachments. Two Dentium SuperLine implants were placed in the canine regions of the mandible, and flat magnetic attachments (MKP5530 keeper with MGT5520 magnetic assembly) were used for overdenture retention.
Flat magnetic attachment system used for retention of mandibular implant-supported overdentures. The system consisted of a Dentium MKP5530 keeper and MGT5520 magnetic assembly with a manufacturer-reported retentive force of 700 gf.
其他名称:
  • Dentium MGT5520 Dentium MKP5530
实验性的:Dome Magnetic Attachment Group
Participants received mandibular implant-supported overdentures retained by dome-shaped magnetic attachments. Two Dentium SuperLine implants were placed in the canine regions of the mandible, and dome magnetic attachments (MKP5530D keeper with MGT5520D magnetic assembly) were used for overdenture retention.
Dome-shaped magnetic attachment system used for retention of mandibular implant-supported overdentures. The system consisted of a Dentium MKP5530D keeper and MGT5520D magnetic assembly with a manufacturer-reported retentive force of 700 gf.
其他名称:
  • Dentium MGT5520D Dentium MKP5530D

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Overdenture Retention Force
大体时间:Baseline, 3 months, and 6 months after overdenture loading
Retention force of mandibular implant-supported overdentures retained by flat and dome-shaped magnetic attachments, measured in Newtons (N) using a digital force gauge during vertical dislodgement.
Baseline, 3 months, and 6 months after overdenture loading

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:sawsan maged, Assoc. Prof.、Faculty of dentistry, Ain shams university

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年1月1日

初级完成 (实际的)

2025年4月1日

研究完成 (实际的)

2025年12月1日

研究注册日期

首次提交

2026年6月7日

首先提交符合 QC 标准的

2026年6月7日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月7日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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