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- Essai clinique NCT07657026
Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant (BMAC)
Assessment of Bone Density Following Application of Bone Marrow Aspirate Concentrate Around Zygomatic Implants (Via the Intrasinus Approach): A Case Series Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Zygomatic implants provide a viable option for rehabilitation of the severely atrophic maxilla. However, achieving optimal osseointegration remains a challenge due to poor bone quality in the posterior maxilla. Bone marrow aspirate concentrate contains mesenchymal stem cells and growth factors that may enhance local bone formation.
Knowledge Gap:
BMAC has been investigated with conventional dental implants, but its use with zygomatic implants placed via the intrasinus approach is limited to isolated case reports. A systematic evaluation of its effect on peri-implant bone density and stability in this specific context is lacking. This case series addresses that gap.
Study Design and Setting:
This is a single-center, prospective case series planned at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. The primary hypothesis is that BMAC application will improve bone density and secondary stability of zygomatic implants at 6 months. (Recruitment has not commenced.)
Surgical Procedure:
Under general anaesthesia, approximately 30 ml of bone marrow will be aspirated from the anterior iliac crest. The aspirate will be processed using a double centrifugation protocol to obtain the buffy coat layer, which will then be loaded onto a gelatine sponge. Zygomatic implants will be placed through a lateral sinus window using the intrasinus trajectory. The BMAC-loaded sponge will be applied around the implant prior to closure. Conventional implants will be placed in the anterior maxilla to support the planned full-arch prosthesis.
Follow-up Protocol:
Patients will be reviewed weekly during the first month, then monthly for 6 months. Cone beam computed tomography will be performed immediately postoperatively and at 6 months to assess changes in bone density in Hounsfield Units. Resonance frequency analysis will be performed at 6 months to evaluate secondary implant stability. Adverse events will be recorded throughout the follow-up period.
Ethical Considerations:
The study protocol has been submitted to the Ethics Committee of Scientific Research, Faculty of Dentistry, Cairo University and is currently pending approval. A written informed consent will be obtained from all participants in Arabic prior to enrollment. Patient data will be coded and stored in a secure, password-protected database accessible only to the research team. The study is self-funded with no conflicts of interest declared.
Outcomes:
The primary outcome is the change in peri-implant bone density at 6 months. Secondary outcome includes secondary stability of the implants . Data will be summarized descriptively given the case series design.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tilal Sidahmed Ahmed, BDS
- Numéro de téléphone: 00201555225441
- E-mail: Tilal.sidahmed@dentistry.cu.edu.eg
Sauvegarde des contacts de l'étude
- Nom: Walaa Kadry Hafez, Associate professor of OMFS
- Numéro de téléphone: 00201061527359
- E-mail: walaakadry@dentistry.cu.edu.eg
Lieux d'étude
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Cairo Governate
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Cairo, Cairo Governate, Egypte, 11562
- Faculty of Dentistry, Cairo University , Department of Oral and Maxillofacial Surgery
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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:
- Patients over 18 years old.
- Patients requiring rehabilitation with zygomatic implants in the posterior maxilla.
- Patients who are willing to participate and able to provide informed consent.
Exclusion Criteria:
- Pregnant women.
- Individuals with history of radiation therapy or other contraindications for surgery.
- Patients with bone marrow diseases.
- Patients with local infections at intraoral surgical site or bone marrow aspiration site.
- Patients unwilling to sign the written informed consent.
- Heavy smokers >20 cigarettes per day.
- Patients taking contraindicated drugs such as bisphosphonates.
- Patients with sinus pathology or acute sinusitis.
- Patients with malignancy or pathology of maxilla.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: zygomatic implant group
All eligible participants with atrophied maxilla receiving zygomatic implant placement for fixed prosthetic rehabilitation.
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placement of zygomatic implants via the intrasinus approach in the posterior maxilla of patients with severely atrophied maxilla.
Bone marrow aspirate concentrate prepared by double centrifugation of bone marrow aspirated from anterior iliac crest of the patient then loaded on gelatine sponge and applied around the zygomatic implants.
Conventional implants may be placed in the anterior maxilla.
Procedure performed under general anaesthesia with propofol induction and sevoflurane maintenance.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Bone density around zygomatic implants
Délai: 6 months postoperatively
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Bone density measured using Cone Beam Computed Tomography (CBCT) and expressed in Hounsfield Units (HU)
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6 months postoperatively
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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secondary stability of zygomatic implants
Délai: 6 months postoperatively
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Implant stability measured using Resonance Frequency Analysis (RFA) device (Osstell) and expressed as Implant Stability Quotient (ISQ)
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6 months postoperatively
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ramy Ragab Elbeialy, Professor of OMFS, Cairo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- omfs3-3-20-
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual participant data will not be shared due to ethical restrictions and patient privacy regulations.
IPD will be shared after publication.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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