Retention of Dome and Flat Magnetic Attachments in Mandibular Implant Overdentures Randomized Controlled Clinical Trial
Effect of Two Forms of Magnetic Attachments on Retention of Implant Retained Mandibular Over-Dentures Randomized Controlled Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo, Egipto
- Faculty of Dentistry, Ain Shams University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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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.
Otros nombres:
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Experimental: 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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overdenture Retention Force
Periodo de tiempo: Baseline, 3 months, and 6 months after overdenture loading
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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.
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Baseline, 3 months, and 6 months after overdenture loading
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: sawsan maged, Assoc. Prof., Faculty of Dentistry, Ain Shams University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- magnetic attachments
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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