Comparaison des montures Ti-Mesh pour l'augmentation de l'os alvéolaire
Augmentation de l'os alvéolaire humain : comparaison d'un cadre Ti-mesh CAD-CAM 3D avec un cadre Ti-Mesh conventionnel fabriqué au moment de la chirurgie
This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries.
The device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as Micromesh). The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. A digitally designed frame can then be printed using CAD-CAM software prior to surgery. This should reduce surgical time.
A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives:
- Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
- Compare post-op wound healing -Ti MESH exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- BU Goldman School of Dental Medicine
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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
- Adult dental patients that require moderate 3-D bone augmentation for dental implant site improvement
Exclusion Criteria:
- Poor oral hygiene indices for microbial plaque (PI) and gingival inflammation (GI)
- Patients who have been on Chemotherapy or Radiation therapy within last 5 years.
- Patients under active treatment with following medications: Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate, or Estrogen supplements.
- Subjects under the direct supervision of the PI
- Smoking more than 10 cigarettes per day
- Uncontrolled diabetes or other metabolic disorders
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 |
|---|---|
|
Expérimental: CAD-CAM Ti-Mesh frame
Participants randomized into this arm will have their tooth loss treated with CAD-CAM designed and preprinted Ti-MESH during surgery. |
CAD-CAM technology which is the process of designing and manufacturing a custom-made dental device, or a patient-specific dental device from an industrialized product, with the aid of a computer.will be used to plan and preprint a 3-D Ti-Mesh frame prior to the surgery. |
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Comparateur actif: Conventional Ti-Mesh frame
Participants randomized into this arm will have their tooth loss treated with conventional chairside fabrication of Ti-MESH during surgery. |
A three-dimensional frame or cage of Ti-Mesh or Ti-reinforced d-polytetrafluoroethylene (PTFE) will be fashioned during the surgery to contain, shape and stabilize the bone graft materials (the internal scaffold). This 3-D frame will be custom fabricated from a perforated Ti Mesh sheet material at the time of surgery which takes considerable time and skill. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Bone contour accuracy
Délai: 5 months post op
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Bone contour accuracy will be derived by merger of the post op Cone beam computed tomography (CBCT) DICOM file with the CBCT-1/CEREC-1/Virtual Implant file produced at the planning stage. Accuracy of fit will be calculated for volume and linear measures (4 sides of each implant-MDBL) horizontal and vertical from the implant restorative platform. |
5 months post op
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Total surgical time
Délai: 2 hours
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Total surgical time is defined as from incision time to completion of sutures and will be measured in minutes. |
2 hours
|
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Surgical exposure time for recipient site
Délai: 5 minutes
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Surgical exposure time will be measured for recipient site in minutes |
5 minutes
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Ti-Mesh exposure incidence
Délai: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
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Number of exposures |
1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
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Ti-Mesh exposure size
Délai: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
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Ti-Mesh exposure size will be measured in millimeters |
1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
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Ti-Mesh exposure location
Délai: 1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
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Ti-Mesh exposure location will be documented within mucosa, gingiva, or at the incision line |
1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks
|
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Percentage of Vital bone
Délai: 6 months
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Percentage of vital bone will be measured in histologic sections of bone core taken at time of implant surgery. |
6 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Serge Dibart, DMD, BU Goldman School of Dental Medicine, Oral Biology/Periodontics
- Directeur d'études: Albert M Price, DMD, BU Goldman School of Dental Medicine, Oral Biology/Periodontics
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H-43856
- AP 37 (Autre identifiant: Geistlich Pharma North America Inc)
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
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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