Tooth-borne Interdental Distraction Osteogenesis Along Arch Curvature for Wide Alveolar Clefts Reduction (IDO)
A New Device for Interdental Distraction Osteogenesis for Management of Wide Alveolar Clefts
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Along the journey of treatment of cleft patients, secondary autogenous alveolar bone grafting is the technique basically used for cleft alveolus and palate repair during mixed dentition stage, in order to create bone support for teeth adjacent to the cleft, making a bone matrix through which teeth in the line of the cleft can erupt, re-stabilize alveolar process contour and maxillary segments. In cases with wide alveolar clefts, more than the width of a maxillary canine, failure of this procedure is usually encountered. So, a further step prior to grafting procedure can be done in an attempt to reduce cleft width to enhance success of future grafting.
Distraction osteogenesis (DO) which is a procedure of growing new bone by mechanical stretching of the ordinary pre-existing vascularized bone tissue by a distraction device, where both segments of new alveolar bone as well as attached gingiva are formed can be used here to aid in minimizing cleft width.
The aim of this study was to introduce a new custom-made tooth-borne distractor that could provide 3D control upon using interdental distraction osteogenesis (IDO) with a posterior segment transport anteriorly along curvature of the arch through creating a controlled fracture, then applying this distractor device carrying a bone transport segment forward, decreasing the cleft width anteriorly with another benefit of leaving behind regenerated bone and attached gingiva posteriorly.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Cairo, Egypte, 11566
- Department of Orthodontics, Faculty of Dentistry, Ain Shams University Cairo, Abbaseya, Egypt
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patients with ages ranging from 12 to 25 years old
- Patients with repaired cleft lip and / or palate.
- Patients with wide alveolar clefts more than 6 mm.
- Patients with median facial clefts, absent premaxilla.
- Patients who had previous failed grafting.
Exclusion Criteria:
- Patients with contraindications to general anaesthesia and surgery.
- Patients with syndromic cleft lip and palate.
- Patients with very bad oral hygiene.
- Vulnerable groups.
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 |
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Expérimental: Tooth borne interdental distraction along arch curvature appliance
Patients eligible to the study were prepared to receive interdental distraction osteogenesis.
The appliance was custom made for each patient.
It is made up of orthodontic bands, labial, palatal stainless steel 0.9mm arches and micro expander screw soldered to the first permanent molar and to the first premolar in the transport segment .
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This study aimed to provide a new design of a tooth-borne, custom-made distractor that could be easily constructed and rigid enough for controlled segment transport. After cases' selection, arch expansion was done first. Following expansion, preparation of the osteotomy site was done, through inducing root divergence at site of interdental osteotomy. Osteotomies were performed under general anesthesia using piezo-surgery, there were 2 osteotomies in a L-shape; interdental vertical osteotomy mesial to 1st molar and a horizontal one above apices of teeth in the transport segment. The distraction protocol was a latency period of 7 days, after which appliance activation started with a distraction rate of 0.4 mm/day with a rhythm of twice daily. Activation proceeded till teeth at the edge of the cleft came into contact. Then the appliance was fixed in place for a 3 months consolidation period.
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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Reduction of width of alveolar cleft and oronasal fistula
Délai: 2-3 months
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Reduction or even closure of the wide interdental alveolar defect and the oronasal fistula measured on CBCT radiograph
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2-3 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Dental changes with distraction
Délai: 2-3 months
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Amount of dental tipping that occurred with distraction forces measured on CBCT radiograph
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2-3 months
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Quality of distracted bone
Délai: 3-6 months
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Measurement of bone radio density in Hounsfield Unit from CBCT
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3-6 months
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Loss of anchorage with distraction forces
Délai: 2-3 months
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Amount of distal movement of anchor molar of the assembly as a side effect of the mesial distraction forces measured on CBCT radiograph
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2-3 months
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Collaborateurs et enquêteurs
Parrainer
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FDASU-RecM121715
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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