Clinical Evaluation of Conventional and 3D-printed Implant-supported Overdentures Retained With New Attachment Systems (IODs)
7 mai 2026 mis à jour par: Mohamed Moustafa, Al-Azhar University
Randomized Crossover Clinical Trial Comparing Two Denture Designs (A and B) Retained by Two Locator Systems (ST and EMI) in Implant Overdenture Patients
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Description détaillée
This randomized crossover clinical trial evaluates patient-reported outcomes and clinical performance of implant overdentures (IODs) using two different denture designs (A and B) retained by two locator attachment systems: Locator ST and Locator EMI.
Each participant will receive both denture designs in a crossover sequence, allowing direct within-subject comparison.
Type d'étude
Interventionnel
Inscription (Estimé)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Asyut, Egypte
- Faculty of Dental Medicine, Al-Azhar University, (Assiut Branch)
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Completely edentulous patients
- Non-smokers
- Patients free from intra-oral diseases that may affect implant-overdenture prognosis
- Patients free from systemic conditions that may influence bone resorption or implant success
- Able and willing to comply with study visits and follow-up schedule
Exclusion Criteria:
- Smokers or tobacco users
- Presence of active oral lesions, infections, or mucosal pathology
- Systemic diseases affecting bone metabolism (e.g., uncontrolled diabetes, osteoporosis requiring bisphosphonates)
- History of head and neck radiation
- Severe parafunctional habits (e.g., bruxism)
- Inability to attend follow-up appointments or provide informed consent
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Arm 1: Denture A with Locator ST Participants receive Denture A retained by Locator ST attachments.
Participants receive Denture A retained by Locator ST attachments.
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Participants receive Denture A, a conventional mandibular implant overdenture, retained by two Locator ST attachments placed in the interforaminal region.
Outcomes include OHIP-19, VAS satisfaction, retention force, attachment wear, periodontal parameters, and denture tooth wear resistance.
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Expérimental: Denture A with Locator EMI
Participants receive Denture A retained by two Locator EMI attachments.
Same outcome measures as above, allowing comparison of attachment type influence on patient-reported and clinical outcomes.
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Participants receive Denture A, a conventional mandibular implant overdenture, retained by two Locator ST attachments placed in the interforaminal region.
Outcomes include OHIP-19, VAS satisfaction, retention force, attachment wear, periodontal parameters, and denture tooth wear resistance.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Retention Force of Implant Overdentures (IODs)
Délai: Outcome measures were assessed at four clearly defined time points: 1. Baseline (Immediately after overdenture pick up) 2. 3 month follow up 3. 6 month follow up 4. 9 month follow up These time points correspond to the evaluation of implant overdentures
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Retention force measured using a digital force gauge to quantify the dislodgement force required to remove the overdenture from the implants.
Measurements will be reported in Newtons (N).
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Outcome measures were assessed at four clearly defined time points: 1. Baseline (Immediately after overdenture pick up) 2. 3 month follow up 3. 6 month follow up 4. 9 month follow up These time points correspond to the evaluation of implant overdentures
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Denture Wear of Implant Overdentures (IODs)
Délai: Wear was evaluated relative to the baseline measurement taken immediately after pick-up, with follow-up assessment 9-month per denture type: 1. 3 month follow up 2. 6 month follow up 3. 9 month follow up
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Denture wear assessed by measuring surface loss on occlusal surface using digital analysis.
Wear depth recorded in millimeters (mm) at each evaluation point.
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Wear was evaluated relative to the baseline measurement taken immediately after pick-up, with follow-up assessment 9-month per denture type: 1. 3 month follow up 2. 6 month follow up 3. 9 month follow up
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Peri-implant Soft Tissue Health (Modified Plaque Index and Modified Bleeding Index Scores)
Délai: Assessments performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
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Peri-implant soft tissue health assessed using the Modified Plaque Index (mPI) and Modified Bleeding Index (mBI). Both indices are ordinal clinical scales scored according to standard peri-implant evaluation criteria: mPI range: 0-3 0 = no plaque 3 = abundant plaque mBI range: 0-3 0 = no bleeding 3 = profuse bleeding Interpretation: Higher scores indicate worse peri-implant soft tissue health. Unit of Measure: Ordinal index scores (mPI, mBI) |
Assessments performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
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Crestal bone level changes
Délai: Radiographic measurements performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
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Crestal bone levels measured on standardized periapical radiographs taken with a paralleling technique.
Bone level is defined as the distance from the implant shoulder to the first bone-to-implant contact.
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Radiographic measurements performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
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Oral Health-Related Quality of Life (OHIP-19 score)
Délai: OHIP-19 scores recorded three times during each 9-month denture phase: 1 -Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
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Oral health-related quality of life assessed using the Oral Health Impact Profile-19 (OHIP-19) questionnaire. The OHIP-19 consists of 19 items, each scored on a 5-point ordinal scale from 0 to 4: 0 = never 4 = very often Minimum score: 0 Maximum score: 76 Interpretation: Higher scores indicate worse oral health-related quality of life. |
OHIP-19 scores recorded three times during each 9-month denture phase: 1 -Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
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Patient Satisfaction (Visual Analog Scale Score)
Délai: VAS satisfaction scores recorded three times during each 9-month denture phase: 1 - Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
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Patient satisfaction with the denture and attachment system measured using a 10-point Visual Analog Scale (VAS). Participants rated their satisfaction on a scale from 0 to 10: 0 = completely dissatisfied 10 = completely satisfied |
VAS satisfaction scores recorded three times during each 9-month denture phase: 1 - Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2024
Achèvement primaire (Estimé)
1 juin 2026
Achèvement de l'étude (Estimé)
1 août 2026
Dates d'inscription aux études
Première soumission
25 avril 2026
Première soumission répondant aux critères de contrôle qualité
7 mai 2026
Première publication (Réel)
12 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Al-Azhar University, (Assiut B
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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