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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Cairo, Egito
- Faculty of dentistry, Ain shams university
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
Outros nomes:
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Overdenture Retention Force
Prazo: 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
- Diretor de estudo: sawsan maged, Assoc. Prof., Faculty of dentistry, Ain shams university
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- magnetic attachments
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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