Study on OsseoSpeed™ TX Short Implants in a Chinese Population

Study Overview
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Brief Summary
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The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.

Official Title
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An Open, Prospective, Multi-center Study Assessing the OsseoSpeed™ TX Length 6 mm in in the Posterior Maxilla and Mandible. A 3-years Follow-up Study.

Conditions
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Partially Edentulous Jaw

Intervention / Treatment
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* Device: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Provision of informed consent Female and male aged 20-75 years at enrolment In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region) History of edentulism in the study area of at least four months Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s) Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 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 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 implants<br>OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm. | Device: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)<br> <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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading. Positive value = bone gain, Negative values = bone loss. | Evaluated from implant installation to 12 months after implant loading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal Bone Level Alteration After 36 Months | 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, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 36 months after loading. Positive value = bone gain, Negative values = bone loss. | Evaluated from implant loading to 36 months after implant loading. | 
| Implant Survival | Implant survival rate evaluated clinically and radiographically. | Evaluated from implant installation to 36 months after implant loading. | 
| Implant Stability | Implant stability evaluated clinically/manually (recorded as stable yes/no). | Evaluated 36 months after implant loading. | 
| Condition of the Periimplant Mucosa (PPD). | Condition of the periimplant mucosa measured by assessment of probing pocket depth (PPD). Change in pocket depth expressed in millimeters at the 36 month follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Negative value = increased pocket depth | Evaluated from implant loading to 36 months after implant loading. | 
| Condition of the Periimplant Mucosa (BoP). | Condition of the periimplant mucosa will be measured by assessment of bleeding on probing (BoP). Presented as % of the implants that show presence of bleeding at time of the 36 months follow-up. | Evaluated from implant loading to 36 months after implant loading. | 
| Plaque | Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit. | Evaluated 36 months after implant loading. | 
| Crown-to-implant Ratio | Crown height measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis. The crown-to-implant ratio calculated from radiographs | 12 months after implant loading |