Study on OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours
This study has been completed.
Sponsor:
Dentsply Implants
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00711022
First received: July 7, 2008
Last updated: June 21, 2012
Last verified: June 2012
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Purpose
The purpose of the study is to evaluate Astra Tech Implants, Fixture MicroThread™ OsseoSpeed™, in patients with totally edentulous upper jaws and poor bone quality and quantity, when provisional artificial teeth are attached within 24 hours. The primary objective is to investigate implant survival rate.
| Condition | Intervention |
|---|---|
|
Jaw, Edentulous |
Device: OsseoSpeed™ |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open, Prospective, Multicenter Study to Evaluate the Outcome of Astra Tech Implants, Fixture MicroThread™ OsseoSpeed™, in Patients With Totally Edentulous Maxillas and Poor Bone Quality and Quantity in an Immediate Loading Protocol. |
Further study details as provided by Dentsply Implants:
Primary Outcome Measures:
- Implant survival rate [ Time Frame: From implant placement until 5-year follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | May 2005 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Device: OsseoSpeed™
OsseoSpeed™ MicroThread™, all dimensions.
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of informed consent
- 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:
- Unlikely to be able to comply with study procedures, as judged by the investigator
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711022
Locations
| United States, Illinois | |
| The University of Chicago, MC-2108 | |
| Chicago, Illinois, United States, 60637 | |
| Sweden | |
| Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine | |
| Uppsala, Sweden, SE-751 85 | |
Sponsors and Collaborators
Dentsply Implants
Investigators
| Principal Investigator: | Joseph A Toljanic, Prof. | University of Chicago |
More Information
Publications:
| Responsible Party: | Dentsply Implants |
| ClinicalTrials.gov Identifier: | NCT00711022 History of Changes |
| Other Study ID Numbers: | YA-OSS-0008 |
| Study First Received: | July 7, 2008 |
| Last Updated: | June 21, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board Sweden: Regional Ethical Review Board |
Keywords provided by Dentsply Implants:
|
Jaw, Edentulous (maxilla, with poor bone quality and quantity) |
Additional relevant MeSH terms:
|
Jaw, Edentulous Mouth, Edentulous Jaw Diseases Musculoskeletal Diseases |
Stomatognathic Diseases Mouth Diseases Tooth Diseases |
ClinicalTrials.gov processed this record on May 22, 2013