Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later

Study Overview
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Brief Summary
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The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior maxilla in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.

Official Title
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An Open, Prospective Study to Evaluate Implant Stability, Marginal Bone Adaptation and the Survival Rate of Astra Tech Dental Implant System, Fixture Osseospeed™, in Patients With Tooth Loss in the Posterior Maxilla in an Early Loading Protocol.

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: OsseoSpeed™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written informed consent 18 years of age and over Edentulous in the posterior maxilla, Kennedy classes I or II. Last natural tooth, or previously restored implant in function is canine or first bicuspid. Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading Exclusion Criteria: Untreated caries and/or periodontal disease of residual dentition History of edentulism in the area of implant placement of less than two months Current need for pre-surgical bone or soft tissue augmentation in the planned implant area. History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area. Sinus floor thickness of less than 5 mm, verified by periapical radiographs. Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration Present alcohol or drug abuse Unable or unwilling to return for follow-up visits for a period of 5 years Current use of smoking tobacco Pregnancy or lactation at the time of enrollment

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: OsseoSpeed™<br>* OsseoSpeed™, all dimensions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival Rate | An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants. | At 5 year follow-up | 
| Implant Stability | Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (<60) indicate low stability, medium values (60-70) indicate medium stability and high values (>70) indicate high stability. | At 1 year follow-up | 
| Marginal Bone Adaptation | Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss. | At baseline (loading) and at 5 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jaw, Edentulous, Partially (posterior maxilla)