Study of Bone Preservation When Fixture MicroThread™ OsseoSpeed™ is Placed Immediately Following Tooth Extraction. - Tabular View

Tracking Information
First Received Date ^ICMJE	July 7, 2008
Last Updated Date	January 8, 2009
Start Date ^ICMJE	December 2005
Estimated Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 7, 2008)	Clinical measure of the thickness of the facial bone wall. [ Time Frame: At implant placement and after 16 weeks of healing. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00711282 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Bone Preservation When Fixture MicroThread™ OsseoSpeed™ is Placed Immediately Following Tooth Extraction.
Official Title ^ICMJE	A Prospective, Randomized, Controlled Study to Evaluate Buccal Bone Preservation Using Fixture MicroThread™ OsseoSpeed™ Placed in Fresh Extraction Sockets the Maxilla.
Brief Summary	The purpose of this study is to evaluate the clinical performance of implants placed in individuals who are about to loose one or more of their upper teeth. The main objective is to study how the surrounding bone tissue reacts to two different shapes of implants. Clinical performance, in wider terms, means esthetics and long lasting function. Half of the patients will receive a cylindrically shaped implant and the other half will receive a conical-cylindrical implant. The implants will be placed and after a healing period of 16 weeks the gum will be re-opened and the bone tissue response clinically evaluated. Permanent artificial tooth/teeth will be attached six weeks after that.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Jaw, Edentulous, Partially
Intervention ^ICMJE	Device: OsseoSpeed™
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	104
Completion Date
Estimated Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Provision of written informed consent At least 18 years at inclusion At least 20 teeth with expected functional balanced occlusion after restoration In need of one or more implants replacing teeth to be removed in the maxilla within region 15 to 25 Presence of an intact extraction socket following removal of the natural tooth defined by: (1) a situation where the marginal border of the facial bone crest deviates less than or equal to 2 mm from that of the expected normal anatomy of the site/region, (2) a marginal border of a potential facial fenestration at least 3 mm apical of the marginal bone crest Presence of an extraction socket anatomy, following removal of the natural tooth, suitable for both cylindrical and conical/cylindrical implants Exclusion Criteria: Untreated rampant caries and uncontrolled periodontal disease Absence of adjacent (mesial and/or distal) natural tooth root Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent / non-insulin dependent Diabetes Mellitus) Current alcohol or drug abuse 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 History of radiation in the head and neck region History of chemotherapy within 5 years prior to surgery Unable or unwilling to return for follow-up visits for a period of 3 years and 6 months Unrealistic esthetic demands Unlikely to be able to comply with study procedures according to Investigators judgement Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the investigational site) Previous enrolment in this study
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy, Spain, Switzerland

Administrative Information
NCT ID ^ICMJE	NCT00711282
Responsible Party	Head of Therapeutic Area Dental, Clinical Research, Astra Tech AB
Study ID Numbers ^ICMJE	YA-OSS-0009
Study Sponsor ^ICMJE	Astra Tech AB
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Astra Tech AB
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP