Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw

Study Overview
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Brief Summary
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The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.

Official Title
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An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: OsseoSpeed™ length 6 mm
* Device: OsseoSpeed™ length 11 mm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent Aged 20-70 years at enrolment History of edentulism in the study area of at least four months Neighboring tooth/teeth to the planned bridge must have natural root(s) 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 a bone height of at least 11 mm and a bone width of minimum 6 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 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 enrolment in the present study. Severe non-compliance to protocol as judged by the investigator and/or Astra Tech 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: 20 Years
Maximum Age: 70 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: Group-1, Implant length 6 mm<br>Subjects treated with OsseoSpeed™ implant, length: 6 mm | Device: OsseoSpeed™ length 6 mm<br>* OsseoSpeed™ dental implant, length: 6 mm<br>|
| Other: Group-2, Implant length 11 mm<br>Subjects treated with OsseoSpeed™ implant, length: 11 mm | Device: OsseoSpeed™ length 11 mm<br>* OsseoSpeed™ dental implant, length: 11 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological Assessments of Marginal Bone Level Alteration | Marginal Bone Level 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 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss. | Evaluated from implant installation to 5 years follow-up after implant placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Implant Survival | Overall implant survival, measured on implant level | Evaluated 5 years after implant placement | 
| Evaluation of the Periimplant Mucosa Condition - By Assessment BoP | Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP. | Measured at the 5-year follow-up visit after loading | 
| Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD | Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline). Negative value = increased pocket depth. | Evaluated at implant loading and at the 5-year follow-up visit. | 
| Presence of Plaque | Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection. A study position was considered as bleeding yes if at least one of the four surfaces around the implant showed presence of bleeding on probing. | Evaluated at the 5-year follow-up visit after loading. |