- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07932418
Assessment of the Oblique Sandwich Osteotomy for Augmentation of Posterior Atrophic Mandible
Rehabilitation of the partially or totally edentulous mandible with implant supported prosthesis has become a common practice in the last few decades. Local conditions of the edentulous ridges may be unfavorable for dental implant placement, where sufficient bony support in both the horizontal and vertical dimensions is the foundation of any successful oral rehabilitation with dental implants.
Challenges include the resorpative changes of the alveolar ridge after tooth extractions and the hard tissue deficits due to chronic periodontal disease or congenitally missing teeth. Neoplasm, osteomyelitis, cysts or trauma can also compromise the situation. All these factors require the oral implantologist to create using regenerative techniques sufficient hard tissue support at the appropriate site before or during dental implant installation.
Multiple bone grafting materials and techniques have been used to reconstruct the partially dentate and edentulous posterior mandibular ridges with high rates of success, these techniques include block onlay grafting technique, guided bone regeneration using membranes or meshes and distraction osteogenesis. The selection of the optimal technique depends on various factors, including the degree of the defect, the grafted bone substitute available, the medical condition of the patient and also the skill and experience of the operator.
The aim of this study is to evaluate the alveolar bone volume by the CBCT after performing oblique sandwich osteotomy in conjunction with interpositional autogenous bone grafting in the atrophied posterior mandible.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Rehabilitation of the partially or totally edentulous mandible with implant supported prosthesis has become a common practice in the last few decades. Local conditions of the edentulous ridges may be unfavorable for dental implant placement, where sufficient bony support in both the horizontal and vertical dimensions is the foundation of any successful oral rehabilitation with dental implants.
Challenges include the resorpative changes of the alveolar ridge after tooth extractions and the hard tissue deficits due to chronic periodontal disease or congenitally missing teeth. Neoplasm, osteomyelitis, cysts or trauma can also compromise the situation. All these factors require the oral implantologist to create using regenerative techniques sufficient hard tissue support at the appropriate site before or during dental implant installation.
Multiple bone grafting materials and techniques have been used to reconstruct the partially dentate and edentulous posterior mandibular ridges with high rates of success, these techniques include block onlay grafting technique, guided bone regeneration using membranes or meshes and distraction osteogenesis. The selection of the optimal technique depends on various factors, including the degree of the defect, the grafted bone substitute available, the medical condition of the patient and also the skill and experience of the operator.
The aim of this study is to evaluate the alveolar bone volume by the CBCT after performing oblique sandwich osteotomy in conjunction with interpositional autogenous bone grafting in the atrophied posterior mandible.
In this study ten atrophied posterior mandibular regions will be augmented with autogenous interpositional particulate bone harvested from the ipsilateral retromolar area through the oblique sandwich osteotomy procedure. The mobilized segment will be stabilized by using 2.0 manipulates and screws. The graft is then covered by platelet rich fibrin membrane.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: nehal Shobair lecturer, PhD
- Numéro de téléphone: 010171181794
- E-mail: nehalshobair@dent.asu.edu.eg
Lieux d'étude
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Cairo, Egypte
- Recrutement
- Faculty of Dentistry Ain Shams Univeristy
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Contact:
- nehal Shobair lecturer, Phd
- E-mail: nehalshobair@dent.asu.edu.eg
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Contact:
- Numéro de téléphone: +201017181749
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Partially edentulous patients with moderate to severe posterior atrophic mandibular ridges,
- Sufficient alveolar bone width for implant placement (at least 7 mms),
- A native alveolar bone height above the mandibular alveolar canal till the alveolar crest (measuring from 5 to 9 mms),
- Adequate inter-arch space,
- The site of the graft is free from any pathologic lesion as cyst, infection or tumor.
Exclusion Criteria:
- The patients suffering from any systemic and metabolic disease that may affect normal healing of bone and soft tissue as diabetes or osteoporosis
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 |
|---|---|
|
Comparateur actif: oblique sandwich osteotomy augmenation
atrophic posterior mandibular regions wiil be augmented with autogenous interpositional particulate bone harvested from the ipsilateral retromolar area through the oblique sandwich osteotomy procedure. The mobilized segment will be stabilized by using 2.0 manipulates and screws. The graft is then covered by platelet rich fibrin membrane. |
atrophic posterior mandibular regions is augmented with autogenous interpositional particulate bone harvested from the ipsilateral retromolar area through the oblique sandwich osteotomy procedure. The mobilized segment is stabilized by using 2.0 manipulates and screws. The graft is then covered by platelet rich fibrin membrane. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinical evaluation
Délai: 4 months
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clinical evalauation of the occurrence of any complications after augmentation involving wound dehiscence, infection, neuro-sensory disturbance and for the stability of the augmented alveolar ridges |
4 months
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Radiographic evaluation
Délai: 4 months
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Linear and volumetric Measurements to calculate first the post-operative CBCT bone volume then the volume of the plate is calculated separately and subtracted from the postoperative volume. The preoperative and postoperative CBCTs and the difference in volume is calculated through subtraction of postoperative and preoperative results |
4 months
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Autres numéros d'identification d'étude
- 1415
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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