- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Beijing, Cina, 100081
- Department of Periodontology, School of Stomatology, Peking University
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Beijing, Cina
- Department of Implantology, School of Stomatology, Peking University
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Beijing, Cina
- Second Dental and Periodontal Center, School of Stomatology, Peking University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: OsseoSpeed™ TX implants
OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Marginal Bone Level Alteration
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Marginal Bone Level Alteration After 36 Months
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).
Lasso di tempo: 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).
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Huan Xin Meng, Prof, Department of Periodontology, School of Stomatology, Beijing University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHN-0005
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)
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University of Campania "Luigi Vanvitelli"Dentsply Sirona Implants and ConsumablesSconosciuto
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Dentsply Sirona Implants and ConsumablesCompletatoMascella, Edentulo, ParzialmenteStati Uniti, Austria, Polonia, Spagna, Svizzera
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Clark StanfordRitiratoPerdita dei dentiStati Uniti