Status:
COMPLETED
Study on OsseoSpeed™ TX Narrow Implants in the Lower Jaw in a Chinese Population
Lead Sponsor:
Dentsply Sirona Implants and Consumables
Conditions:
Partially Edentulous Jaw
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Provision of informed consent
- Aged 20-75 years at enrolment
- History of edentulism in the study area of at least two months
- Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
- 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 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 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 enrollment in the present study
- Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01473355
Start Date
October 1 2011
End Date
October 1 2016
Last Update
October 15 2019
Active Locations (3)
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1
School of Stomatology, JiLin University, Hospital of Stomatology
Changchun, China
2
Sichuan University
Chengdu, China, 610041
3
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China, 310003