Study Evaluating OsseoSpeed™ Narrow Implant in the Upper and Lower Anterior Jaw

Study Overview
=================
Brief Summary
-----------------
To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.

Official Title
-----------------
An Open, Prospective, Single Arm, Multi-centre Study Evaluating OsseoSpeed™ Implant 3 mm Diameter Replacing a Central or Lateral Mandibular Incisor or Lateral Maxillary Incisor. A 5-year Follow-up Study.

Conditions
-----------------
Jaw, Edentulous, Partially

Intervention / Treatment
-----------------
* Device: OsseoSpeed™ TX 3.0S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Aged 18-70 years at enrolment History of edentulism in the study area of at least two months Presence of natural tooth roots adjacent to the study implant position Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant 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 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, as deemed by the investigator Uncontrolled diabetes mellitus Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration Smoking more than 10 cigarettes per 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 weeks prior to enrolment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 3.0S (Dental implant)<br>OsseoSpeed™ TX 3.0S, Dental implants, 3.0 mm diameter, in lengths of 11, 13 and 15 mm | Device: OsseoSpeed™ TX 3.0S<br>* OsseoSpeed™ TX 3.0 mm diameter<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival Rate | Overall implant survival rate evaluated clinically and radiographically | Evaluated at implant placement and at the 5 years follow-up after implant placement |