- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04205591
Comparative Study Between Porcine and Autologous Cortical Plates
Split Bone Block Technique: Clinical and Radiographic Study Between Autologous and Porcine Xenogeneic Cortical Plates. Randomized Clinical Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients were enrolled in the study on the basis of having insufficient bone height (<6mm), width (<3mm) or both, in either maxilla or mandible
Exclusion Criteria:
Patients with severe systemic disease (American Society of Anesthesiology III or IV) were excluded from the study.
In addition, patients who were pregnant, or patients with diseases affecting bone, such as:Paget's disease, osteomalacia, diabetes, vitamin D deficiency, alcoholism, hyperthyroidism cancer or osteoporosis as well as those on medications that might affect bone metabolism, such as bisphosphonates, corticosteroids or antiepileptic medicaments were also excluded from the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Autologous cortical plate
Thin autologous cortical plates that allow to made a rigid and resistant framework that will be filled with autogenous bone chips bone
|
A graft surgery using autogenous bone chips surrounded by a rigid framework made over the atrophic sites of the mandible and maxilla to obtain bone augmentation to support dental implants
|
Eksperimentell: Porcine cortical plate
Thin porcine cortical platesthat allow to made a rigid and resistant framework that will be filled with autogenous bone chips bone
|
A graft surgery using autogenous bone chips surrounded by a rigid framework made over the atrophic sites of the mandible and maxilla to obtain bone augmentation to support dental implants
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Volume of bone augmentation
Tidsramme: 4 months
|
Volume of bone augmentation of the surgical sites was measured in the postoperative parasagittal CT scans using a region of interest (ROI) containing the entire bone box regenerated area using the closed polygon tool of the OsiriX software.
This measurements have been done in mm3
|
4 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Postoperative pain
Tidsramme: 4 months
|
The amount of pain was classified into three categories: heavy pain, with the patient taking more than eight painkillers (ibuprofen 400); moderate pain, when the patient took four to eight painkillers; or little pain, when the patient needed fewer than four painkillers.
|
4 months
|
Bone box time consuming
Tidsramme: Minutes
|
In the control group this was measured from the moment the osteotomy incision began with the MicroSaw until the bone block was completely removed, splitting cortical plates and fixation to the buccal and lingual/palatal side of the bone defect using osteosynthesis screws after it is filled with the bone chips harvested previously.
In experimental group the time was measured from the open of porcine cortical plate envelope until the bone box was completely filled and sealed.
|
Minutes
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jesús Torres, Associate, Universidad Complutense de Madrid
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- P-15/567
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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