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

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

This study is ongoing, but not recruiting participants.

Study NCT00711282. Last updated on July 7, 2008. Information provided by Astra Tech AB

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Study of Bone Preservation When Fixture MicroThread™ OsseoSpeed™ is Placed Immediately Following Tooth Extraction.
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary Outcome Measure ^†	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 ]
Secondary Outcome Measure ^†
Condition ^†	Jaw, Edentulous, Partially
Intervention ^†	Device: Fixture MicroThread OsseoSpeed, diameters of 3.5 and 4.0 mm. Device: Fixture MicroThread OsseoSpeed, diameters of 4.5 and 5.0 mm.
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	104
Start Date ^†	December 2005
Completion Date
Eligibility Criteria ^†	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 ^††
Location Countries ^†	Italy, Spain, Switzerland

Administrative Information Fields
NCT ID ^†	NCT00711282
Organization ID	YA-OSS-0009
Secondary IDs ^††
Study Sponsor ^†	Astra Tech AB
Collaborators ^††
Investigators ^†
Information Provided By	Astra Tech AB
Verification Date	July 2008
First Received Date ^†	July 7, 2008
Last Updated Date	July 7, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.