NCT00646113CompletedNot Applicable
An Open, Prospective, Single Arm, Multi-centre Study Evaluating OsseoSpeed™ Implant 3 mm Diameter Replacing a Central or Lateral Mandibular Incisor or Lateral Maxillary Incisor. A 5-year Follow-up Study.
Dentsply Sirona Implants and Consumables12 sites in 6 countries72 target enrollmentStarted: March 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 72
- Locations
- 12
- Primary Endpoint
- Implant Survival Rate
Study Overview
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 implant survival after 5 years is equal to what has been observed with comparable implants in current literature.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 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 enrolment in the present study
- •Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrolment
Outcomes
Primary Outcomes
Implant Survival Rate
Time Frame: Evaluated at implant placement and at the 5 years follow-up after implant placement
Overall implant survival rate evaluated clinically and radiographically
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (12)
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