N/A
N=69
Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw
Jaw, Edentulous, Partially
Bottom Line
View on ClinicalTrials.gov: NCT00646113 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Implant Survival Rate — 93 Implants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OsseoSpeed™ TX 3.0S (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dentsply Sirona Implants and Consumables
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Implant Survival Rate |
93 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00646113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.