NCT01389258CompletedNot Applicable
An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Maxilla. A 3-years Follow-up Study.
Dentsply Sirona Implants and Consumables3 sites in 1 country45 target enrollmentStarted: June 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 3
- Primary Endpoint
- Implant Survival
Study Overview
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 implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of informed consent
- •Aged 20-75 years at enrollment
- •History of edentulism in the study area of at least two months
- •Neighboring tooth/teeth to the planned crown(s) must have natural root(s)
- •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
Arms & Interventions
OsseoSpeed™ TX
Experimental
OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
Intervention: OsseoSpeed™ TX (Device)
Outcomes
Primary Outcomes
Implant Survival
Time Frame: Measured at the 3-year follow-up visit after implant loading.
Implant survival rate evaluated clinically and radiographically.
Secondary Outcomes
- Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).(Measured at implant loading and at the 3-year follow-up visit after loading.)
- Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).(Measured at implant loading and at the 3-year follow-up visit after loading.)
- Presence of Plaque(Measured at the 3-year follow-up visit after implant loading.)
- Implant Stability(Measured at the 3-year follow-up visit after implant loading.)
- Marginal Bone Level Alteration(Measured at the 3-year follow-up visit after implant loading.)
- Gingival Zenith Score(Measured at implant loading and at the 3-year follow-up visit after loading.)
Investigators
Study Sites (3)
Loading locations...
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