Status:
COMPLETED
Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw
Lead Sponsor:
Dentsply Sirona Implants and Consumables
Conditions:
Jaw, Edentulous, Partially
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that im...
Eligibility Criteria
Inclusion
- Provision of informed consent
- Aged 18-70 years at enrolment
- History of edentulism in the study area of at least two months
- Presence of natural tooth roots adjacent to the study implant position
- Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
- Deemed by the investigator as likely to present an initially stable implant situation
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 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, as deemed by the investigator
- Uncontrolled diabetes mellitus
- Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- Smoking more than 10 cigarettes per 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 weeks prior to enrolment
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00646113
Start Date
March 1 2008
End Date
August 1 2014
Last Update
November 18 2019
Active Locations (6)
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1
Tand-mund-kaebekirurgisk Klinik
Copenhagen, Denmark, 2100
2
Bundeswehrkrankenhaus
Ulm, Germany, D-89081
3
Clinica Odontoiatrica
Milan, Italy, 20123
4
Department Oral Surgery, University of Granada: School of Dentistry
Granada, Spain, 18071