Complete EdentulismNCT07642128
Retention of Dome and Flat Magnetic Attachments in Mandibular Implant Overdentures Randomized Controlled Clinical Trial
A study testing Flat Magnetic Attachment and Dome Magnetic Attachment in people with Complete Edentulism and Randomized Clinical Trial, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism, Randomized Clinical Trial
- What is being tested?
- Flat Magnetic Attachment and Dome Magnetic Attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Complete Edentulism, Randomized Clinical Trial
- Being tested
- Flat Magnetic Attachment, Dome Magnetic Attachment
- Keywords
- Randomized Clinical Trial, Retention Force, Implant Overdenture, Mandibular Overdenture, Dental Implants, Overdenture Retention, Magnetic Attachment, Mandibular Implant-Supported Overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flat Magnetic AttachmentDevice
Also called Dentium MGT5520 Dentium MKP5530
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.
Dome Magnetic AttachmentDevice
Also called Dentium MGT5520D Dentium MKP5530D
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Dome Magnetic Attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months after overdenture loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jan 2024
- Primary completion1 Apr 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Elnady, Ain Shams University
- Investigators
- sawsan maged, Assoc. Prof., Study director, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642128
- Sponsor's protocol ID
- magnetic attachments
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32128084
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Forms of Magnetic Attachments on Retention of Implant Retained Mandibular Over-Dentures Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07642128
- Acronym / sponsor ID
- magnetic attachments
- Conditions
- Complete Edentulism, Randomized Clinical Trial
- Keywords
- Randomized Clinical Trial, Retention Force, Implant Overdenture, Mandibular Overdenture, Dental Implants, Overdenture Retention, Magnetic Attachment, Mandibular Implant-Supported Overdenture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the Study The aim of this study is to compare between two forms of magnetic attachments in implant retained mandibular over-dentures.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Flat Magnetic Attachment Group | Experimental | Device: Flat Magnetic AttachmentParticipants 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. |
| Dome Magnetic Attachment Group | Experimental | Device: Dome Magnetic AttachmentParticipants 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flat Magnetic AttachmentAlso: Dentium MGT5520 Dentium MKP5530Flat 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. | Device | Flat Magnetic Attachment Group |
| Dome Magnetic AttachmentAlso: Dentium MGT5520D Dentium MKP5530DDome-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. | Device | Dome Magnetic Attachment Group |
Primary outcome
Overdenture Retention Force
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 32128084Song 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sawsan maged, Assoc. Prof. study director
Faculty of Dentistry, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flat Magnetic Attachment and Dome Magnetic Attachment in people with Complete Edentulism and Randomized Clinical Trial, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overdenture Retention Force (time frame: Baseline, 3 months, and 6 months after overdenture loading). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07642128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.