Complete Edentulism, Randomized Clinical Trial
Conditions
Keywords
Randomized Clinical Trial, Retention Force, Implant Overdenture, Mandibular Overdenture, Dental Implants, Overdenture Retention, Magnetic Attachment, Mandibular Implant-Supported Overdenture
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.
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.
Interventions
DEVICEFlat Magnetic Attachment
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.
DEVICEDome Magnetic Attachment
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overdenture Retention Force | 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. |
Countries
Egypt
Contacts
STUDY_DIRECTORsawsan maged, Assoc. Prof.
Faculty of Dentistry, Ain Shams University
Outcome results
None listed