- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01346696
Study on OsseoSpeed™ TX Short Implants in a Chinese Population
An Open, Prospective, Multi-center Study Assessing the OsseoSpeed™ TX Length 6 mm in in the Posterior Maxilla and Mandible. A 3-years Follow-up Study.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Beijing, Čína, 100081
- Department of Periodontology, School of Stomatology, Peking University
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Beijing, Čína
- Department of Implantology, School of Stomatology, Peking University
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Beijing, Čína
- Second Dental and Periodontal Center, School of Stomatology, Peking University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion criteria:
- Provision of informed consent
- Female and male aged 20-75 years at enrolment
- In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
- History of edentulism in the study area of at least four months
- Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
- Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 mm
- Deemed by the investigator as likely to present an initially stable implant situation
Exclusion criteria:
- Unlikely to be able to comply with study procedures, as judged by the investigator
- Earlier graft procedures in the study area
- Uncontrolled pathologic processes in the oral cavity
- Known or suspected current malignancy
- History of radiation therapy in the head and neck region
- History of chemotherapy within 5 years prior to surgery
- Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes/day
- Present alcohol and/or drug abuse
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- Previous enrolment in the present study
- Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
- Subjects that are unable to give informed consent
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: OsseoSpeed™ TX implants
OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Marginal Bone Level Alteration
Časové okno: Evaluated from implant installation to 12 months after implant loading
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Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading. Positive value = bone gain, Negative values = bone loss. |
Evaluated from implant installation to 12 months after implant loading
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Marginal Bone Level Alteration After 36 Months
Časové okno: Evaluated from implant loading to 36 months after implant loading.
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Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 36 months after loading. Positive value = bone gain, Negative values = bone loss. |
Evaluated from implant loading to 36 months after implant loading.
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Implant Survival
Časové okno: Evaluated from implant installation to 36 months after implant loading.
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Implant survival rate evaluated clinically and radiographically.
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Evaluated from implant installation to 36 months after implant loading.
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Implant Stability
Časové okno: Evaluated 36 months after implant loading.
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Implant stability evaluated clinically/manually (recorded as stable yes/no).
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Evaluated 36 months after implant loading.
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Condition of the Periimplant Mucosa (PPD).
Časové okno: Evaluated from implant loading to 36 months after implant loading.
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Condition of the periimplant mucosa measured by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 36 month follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Negative value = increased pocket depth |
Evaluated from implant loading to 36 months after implant loading.
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Condition of the Periimplant Mucosa (BoP).
Časové okno: Evaluated from implant loading to 36 months after implant loading.
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Condition of the periimplant mucosa will be measured by assessment of bleeding on probing (BoP). Presented as % of the implants that show presence of bleeding at time of the 36 months follow-up. |
Evaluated from implant loading to 36 months after implant loading.
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Plaque
Časové okno: Evaluated 36 months after implant loading.
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Occurence of plaque around the study implant.
Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.
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Evaluated 36 months after implant loading.
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Crown-to-implant Ratio
Časové okno: 12 months after implant loading
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Crown height measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis.
The crown-to-implant ratio calculated from radiographs
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12 months after implant loading
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Huan Xin Meng, Prof, Department of Periodontology, School of Stomatology, Beijing University
Publikace a užitečné odkazy
Obecné publikace
- Han J, Zhang X, Tang Z, Zhang L, Shi D, Meng H. A prospective, multicenter study assessing the DENTSPLY Implants, OsseoSpeed() TX, length 6 mm in the posterior maxilla and mandible: a 1-year follow-up study. Clin Oral Implants Res. 2016 Apr;27(4):452-7. doi: 10.1111/clr.12587. Epub 2015 Apr 9.
- Han J, Tang Z, Zhang X, Meng H. A prospective, multi-center study assessing early loading with short implants in posterior regions. A 3-year post-loading follow-up study. Clin Implant Dent Relat Res. 2018 Feb;20(1):34-42. doi: 10.1111/cid.12568. Epub 2017 Dec 8.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
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
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CHN-0005
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Klinické studie na OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)
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University of Campania "Luigi Vanvitelli"Dentsply Sirona Implants and ConsumablesNeznámý
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Dentsply Sirona Implants and ConsumablesDokončenoČelisti, bezzubé, částečněSpojené státy, Rakousko, Polsko, Španělsko, Švýcarsko