- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00545818
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year 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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Victoria
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Melbourne, Victoria, Australia, 3010
- School of Dental Science, University of Melbourne
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Apeldoorn, Olanda, 7315
- Praktijk De Mondhoek
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London, Regno Unito, SE1 9RT
- King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
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California
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Los Angeles, California, Stati Uniti, 90089-0641
- USC School of Dentistry
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Iowa
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Iowa City, Iowa, Stati Uniti, 52242-1010
- The University of Iowa, College of Dentistry
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Göteborg, Svezia, SE 405 30
- Dept. of Parodontology, Göteborg 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
- Aged 20-70 years at enrolment
- History of edentulism in the study area of at least four months
- Neighboring tooth/teeth to the planned bridge must have natural root(s)
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
- Deemed by the investigator to have a bone height of at least 11 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.
- Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
- Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Group-1, Implant length 6 mm
Subjects treated with OsseoSpeed™ implant, length: 6 mm
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OsseoSpeed™ dental implant, length: 6 mm
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Altro: Group-2, Implant length 11 mm
Subjects treated with OsseoSpeed™ implant, length: 11 mm
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OsseoSpeed™ dental implant, length: 11 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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Radiological Assessments of Marginal Bone Level Alteration
Lasso di tempo: Evaluated from implant installation to 5 years follow-up after implant placement
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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. Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss. |
Evaluated from implant installation to 5 years follow-up after implant placement
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Overall Implant Survival
Lasso di tempo: Evaluated 5 years after implant placement
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Overall implant survival, measured on implant level
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Evaluated 5 years after implant placement
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Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
Lasso di tempo: Measured at the 5-year follow-up visit after loading
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Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP).
Presented as s count of implants that show presence of BoP.
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Measured at the 5-year follow-up visit after loading
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Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
Lasso di tempo: Evaluated at implant loading and at the 5-year follow-up visit.
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Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. |
Evaluated at implant loading and at the 5-year follow-up visit.
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Presence of Plaque
Lasso di tempo: Evaluated at the 5-year follow-up visit after loading.
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Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection. A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing. |
Evaluated at the 5-year follow-up visit after loading.
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Collaboratori e investigatori
Investigatori
- Direttore dello studio: Anna-Karin Lundgren, Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN
Pubblicazioni e link utili
Pubblicazioni generali
- Gulje F, Abrahamsson I, Chen S, Stanford C, Zadeh H, Palmer R. Implants of 6 mm vs. 11 mm lengths in the posterior maxilla and mandible: a 1-year multicenter randomized controlled trial. Clin Oral Implants Res. 2013 Dec;24(12):1325-31. doi: 10.1111/clr.12001. Epub 2012 Sep 3.
- Zadeh HH, Gulje F, Palmer PJ, Abrahamsson I, Chen S, Mahallati R, Stanford CM. Marginal bone level and survival of short and standard-length implants after 3 years: An Open Multi-Center Randomized Controlled Clinical Trial. Clin Oral Implants Res. 2018 Aug;29(8):894-906. doi: 10.1111/clr.13341. Epub 2018 Jul 12.
Studiare le date dei record
Studia le date principali
Inizio studio
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
- YA-SHO-0001
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™ length 6 mm
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