Status:
COMPLETED
Study on ASTRA TECH Implant System, OsseoSpeed™ Implants in Patients Missing All Teeth in the Upper Jaw, Restored With Provisional Teeth Within 24 Hours
Lead Sponsor:
Dentsply Sirona Implants and Consumables
Conditions:
Jaw, Edentulous
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate ASTRA TECH Implant System, OsseoSpeed™ implants, in patients with totally edentulous upper jaws and poor bone quality and quantity, when provisional artificial ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00711022
Start Date
May 1 2005
End Date
March 1 2012
Last Update
July 16 2014
Active Locations (2)
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1
The University of Chicago, MC-2108
Chicago, Illinois, United States, 60637
2
Uppsala University Hospital, Dept. of Surgical Sciences, Oral and Maxillofacial Surgery, Faculty of Medicine
Uppsala, Sweden, SE-751 85