- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01361321
Bone Quality and Quantity Following Guided Bone Regeneration
Examining Bone Quantity and Quality Following Standard Guided Bone Regeneration Procedures
Edentulism refers to a state of full or partial lack of teeth. This situation may interfere with essential functions such as mastication, speech and even appearance.
Dental implants inserted to the mandible or maxilla is a common treatment modality aiming to restore edentulus alveolar ridges by providing support and anchorage for removable or fixed dental prosthesis.There are cases which in addition to a lack of teeth suffer from lack of sufficient bone tissue volume to support the dental implant.A situation like this may originate from a variety of reasons such as residual bone atrophy, prior alveolar bone destruction due to periodontal disease and even a traumatic tooth extraction. In such cases, a routine alveolar bone augmentation is done to enable a dental implant installation at this site.Guided bone regeneration (GBR) is a widely used technique used to augment edentulus bone ridges. It relies on an inert membrane covering a bone substitute placed over the bony site requiring augmentation. The bone substitute provides a scaffold to alveolar regeneration by the host's osteoblasts while the membrane prevents unwanted epithelial cells to migrate to the bony defect area.
The investigators research is a aimed to preform a follow up after patients who already went through a GBR procedure and before inserting a dental implant. Patients answering the inclusion but not the exclusion criteria will go through an alveolar computerized tomography (C.T) done routinely before inserting dental implants.At the day of Dental implantation - residual bone left from the site of implantation (after preparing the site with a trephine bur) will be taken to a histological analysis. The results from the C.T and the histological examination will be analyzed for bone quantity (volume) and quality and will allow a comparison of bone characteristics obtained by using different routinely used bone substitutes.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Jerusalem,, Izrael
- Hadassah Medical Organization
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Healthy men and women over 18 years of age, eligible for signing
- Patients who went through a GBR procedure previous to an insertion of a dental implant which hasn't been inserted yet
- Patients who understand the meaning of the treatment (routine dental implant insertion) and the follow up study, and approves participation in booth of them
Exclusion Criteria:
- Pregnant or nursing women. children or non judgemental patients
- Patients with uncontrolled diabetas mellitus, rheumatoid arthritis or osteoporosis.
- Patients with a pathology present near the site of dental implantation
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
---|
patients after GBR procedure
The study will comprise of patients who already underwent a routine Guided Bone Regeneration (GBR) procedure in order to augment a bony ridge before dental implant insertion.
The patients will be followed up in order to determine bone quality and quantity formed after the usage of routinely used bone substitutes during GBR procedure.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Volume of the new bone formed after a GBR procedure
Časové okno: Volume of the new bone formed after the GBR procedure will be determined 6-7 months after the GBR procedure and before the insertion of dental implants.
|
Bone volume obtained following a GBR procedure will be detemined through a comparison of a 3 dimensional analysis of computed tomography images done before and after the GBR procedure.
|
Volume of the new bone formed after the GBR procedure will be determined 6-7 months after the GBR procedure and before the insertion of dental implants.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Bone quality
Časové okno: Bone quality will be assesed through histological analysis that will be carried out at the time of implants insertion 7-8 months after the GBR procedure.
|
The collected bone sample will be subjected to histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae,the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio.
|
Bone quality will be assesed through histological analysis that will be carried out at the time of implants insertion 7-8 months after the GBR procedure.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Lior Shapira, Professor, Department of Periodontology
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- bondbone-HMO-CTIL
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .