NCT07642128

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 7, 2026

Last Update Submit

June 7, 2026

Conditions

Keywords

Randomized Clinical TrialRetention ForceImplant OverdentureMandibular OverdentureDental ImplantsOverdenture RetentionMagnetic AttachmentMandibular Implant-Supported Overdenture

Outcome Measures

Primary Outcomes (1)

  • Overdenture Retention Force

    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

Study Arms (2)

Flat Magnetic Attachment Group

EXPERIMENTAL

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.

Device: Flat Magnetic Attachment

Dome Magnetic Attachment Group

EXPERIMENTAL

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.

Device: Dome Magnetic Attachment

Interventions

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.

Also known as: Dentium MGT5520 Dentium MKP5530
Flat Magnetic Attachment Group

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.

Also known as: Dentium MGT5520D Dentium MKP5530D
Dome Magnetic Attachment Group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

  • Song SY, Kang KH, Lee JY, Shin SW. Effects of type of magnet attachment and implant angulation in two implant overdenture models. J Adv Prosthodont. 2020 Feb;12(1):33-37. doi: 10.4047/jap.2020.12.1.33. Epub 2020 Feb 20.

    PMID: 32128084BACKGROUND

Study Officials

  • sawsan maged, Assoc. Prof.

    Faculty of Dentistry, Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups according to the magnetic attachment design used for mandibular implant-supported overdentures. Group I will receive flat magnetic attachments, while Group II will receive dome-shaped magnetic attachments. Retention will be evaluated at baseline, 3 months, and 6 months after overdenture loading.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dentist

Study Record Dates

First Submitted

June 7, 2026

First Posted

June 11, 2026

Study Start

January 1, 2024

Primary Completion

April 1, 2025

Study Completion

December 1, 2025

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations