Study on OsseoSpeed™ TX Implants in a Chinese Population

Study Overview
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Brief Summary
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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 mandible up to 3 years after loading. Hypothesis: Early loading of the posterior mandible is a safe and predictable procedure.

Official Title
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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 Mandible. A 3-years Follow-up Study.

Conditions
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Partially Edentulous Jaw

Intervention / Treatment
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* Device: OsseoSpeed TX


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Provision of informed consent Aged 20-75 years at enrolment History of edentulism in the posterior mandible, 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 enrolment 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OsseoSpeed TX<br>OsseoSpeed TX implants of lengths 8-17 mm | Device: OsseoSpeed TX<br>* OsseoSpeed TX implants of lengths 8-17 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). | Evaluated 3 years after implant loading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival | Implant survival rate evaluated clinically and radiographically. | From implant placement to the follow-up 36 months after loading. | 
| Implant Stability | Implant stability evaluated clinically/manually (recorded as stable yes/no) | Measured from loading of implants to the follow-up 36 months after loading. | 
| Soft Tissue Status (PPD). | Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed. A negative value = increased pocket depth. | Measured from loading of implants to the follow-up 36 months after loading. | 
| Soft Tissue Status (BoP) | Soft tissue status measured by assessment of bleeding on probing (BoP). | Measured from loading of implants to the follow-up 36 months after loading. |