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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Cairo, Egypte
- Faculty of dentistry, Ain shams university
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
Autres noms:
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Expérimental: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overdenture Retention Force
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: sawsan maged, Assoc. Prof., Faculty of dentistry, Ain shams university
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- magnetic attachments
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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