NCT01389245CompletedNot Applicable
An Open, Prospective, Multi-center Study to Evaluate the OsseoSpeed™ TX Implant With an Early Loading Protocol in Patients With Tooth Loss in the Posterior Maxilla. A 3-years Follow-up Study.
Dentsply Sirona Implants and Consumables5 sites in 1 country42 target enrollmentStarted: June 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 5
- Primary Endpoint
- Marginal Bone Level Alteration
Study Overview
Brief Summary
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX implants 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 posterior maxilla 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 posterior maxilla, Kennedy classes I or II, of at least four months. Last natural tooth in function is canine or first bicuspid.
- •Neighboring tooth to the planned bridge must have natural root.
- •Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
- •Deemed by the investigator to have adequate bone height and a bone width of minimum 5.5 mm.
- •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
- •Earlier graft procedures in the study area
- •Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
- •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
- •Uncontrolled diabetes mellitus
- •Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- •Smoking more than 10 cigarettes/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 6 months.
- •Subjects that are unable to give informed consent
Outcomes
Primary Outcomes
Marginal Bone Level Alteration
Time Frame: Measured at implant loading and at the 3-year follow-up after implant loading.
Marginal bone level determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 3-year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Secondary Outcomes
- Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD(Measured at the 3-year follow-up after implant loading.)
- Number of Survived Implants(Measured at the 3-year follow-up after implant loading.)
- Presence of Plaque(Measured at the 3-year follow-up after implant loading.)
- Number of Stable Implants(Measured at the 3-year follow-up after implant loading.)
Investigators
Study Sites (5)
Loading locations...
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