- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: nehal Shobair lecturer, PhD
- Numer telefonu: 010171181794
- E-mail: nehalshobair@dent.asu.edu.eg
Lokalizacje studiów
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Cairo, Egipt
- Rekrutacyjny
- Faculty of Dentistry Ain Shams Univeristy
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Kontakt:
- nehal Shobair lecturer, Phd
- E-mail: nehalshobair@dent.asu.edu.eg
-
Kontakt:
- Numer telefonu: +201017181749
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Clinical evaluation
Ramy czasowe: 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
Ramy czasowe: 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
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 1415
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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