Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours
NCT ID: NCT00711022
Last Updated: 2014-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2005-05-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OsseoSpeed
ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
Interventions
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ASTRA TECH Implant System, OsseoSpeed™, all dimensions.
Eligibility Criteria
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Inclusion Criteria
* Aged 20 years and over
* History of totally edentulous maxilla of at least three months
* Radiographic finding indicating bone quality class 3 or 4 (Lekholm and Zarb) in the maxilla
* Radiographic finding indicating bone quantity class C, D or E (Lekholm and Zarb) in the maxilla
* Presence of natural teeth, partial prosthesis and/or implants in the mandible, within positions 35-45 (according to the FDI digit system)
* Deemed by the investigator as likely to present an initially stable implant situation suitable for immediate loading.
Exclusion Criteria
* Uncontrolled pathologic processes in the oral cavity
* Known or suspected current malignancy
* History of radiation in the head and neck region
* History of chemotherapy within 5 years prior to surgery
* Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Uncontrolled Diabetes Mellitus
* Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* History of bone augmentation in the maxilla within 6 months prior to surgery
* Known pregnancy at time of enrolment
* Present alcohol and/or drug abuse
* Current use of tobacco or history of tobacco use within 6 months prior to surgery
* Need for interpreter
20 Years
ALL
No
Sponsors
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Dentsply Sirona Implants and Consumables
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph A Toljanic, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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The University of Chicago, MC-2108
Chicago, Illinois, United States
Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine
Uppsala, , Sweden
Countries
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References
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Toljanic JA, Baer RA, Ekstrand K, Thor A. Implant rehabilitation of the atrophic edentulous maxilla including immediate fixed provisional restoration without the use of bone grafting: a review of 1-year outcome data from a long-term prospective clinical trial. Int J Oral Maxillofac Implants. 2009 May-Jun;24(3):518-26.
Erkapers M, Ekstrand K, Baer RA, Toljanic JA, Thor A. Patient satisfaction following dental implant treatment with immediate loading in the edentulous atrophic maxilla. Int J Oral Maxillofac Implants. 2011 Mar-Apr;26(2):356-64.
Thor A, Ekstrand K, Baer RA, Toljanic JA. Three-year follow-up of immediately loaded implants in the edentulous atrophic maxilla: a study in patients with poor bone quantity and quality. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):642-9. doi: 10.11607/jomi.3163.
Erkapers M, Segerstrom S, Ekstrand K, Baer RA, Toljanic JA, Thor A. The influence of immediately loaded implant treatment in the atrophic edentulous maxilla on oral health related quality of life of edentulous patients: 3-year results of a prospective study. Head Face Med. 2017 Nov 10;13(1):21. doi: 10.1186/s13005-017-0154-0.
Other Identifiers
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YA-OSS-0008
Identifier Type: -
Identifier Source: org_study_id
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