Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed

Study Overview
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Brief Summary
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To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX

Official Title
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An Open, Randomized, Prospective Multi Centre Study Comparing OsseoSpeedTM TX With OsseoSpeedTM in the Partially and Totally Edentulous Maxillae

Conditions
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Partial Edentulism, Edentulism Nos

Intervention / Treatment
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* Device: OsseoSpeed TX
* Device: OsseoSpeed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent Female/male aged 18 years and over History of edentulism in the study area of at least 3 months In need for implant(s) replacing missing tooth/teeth in the maxilla Deemed by the investigator to be suitable for one stage surgery Deemed by the investigator to be suitable for loading after 10-12 weeks Deemed by the investigator as likely to present an initially stable implant situation. Deemed by the investigator to have a functional opposing dentition at the time of loading the implants. Exclusion criteria: Unlikely to be able to comply with study procedures, as judged by the investigator Uncontrolled pathological 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 would compromise post-operative healing and/or osseointegration Uncontrolled diabetes mellitus Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration Present alcohol and/or drug abuse Current need for bone grafting and/or augmentation in the planned implant area 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 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: OsseoSpeed TX<br>* OsseoSpeedTM TX implants of lengths 6-17 mm<br>|
| Active Comparator: B<br> | Device: OsseoSpeed<br>* OsseoSpeedTM implants of lengths 6-17 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal Bone Level | Marginal Bone Level will be determined from radiographs and expressed as the difference 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 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline). | One year after loading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability | Implant stability will be evaluated clinically/manually (recorded as stable yes/no) | At implant placement (inclusion) (day 1) | 
| Implant stability | Implant stability will be evaluated using Resonance Frequency Analysis (RFA) | At implant placement (inclusion) (day 1) | 
| Implant stability | Implant stability will be evaluated clinically/manually (recorded as stable yes/no) | At implant loading (10-12 weeks after implant placement) | 
| Implant survival | Implant survival rate will be evaluated by clinically and radiographically counting the number of remaining implants from implant placement to one year after loading. | One year after loading | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Edentulism in the Upper Jaw