Study of Bone Preservation When OsseoSpeed™ Implants Are Placed Immediately Following Tooth Extraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00711282
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : June 27, 2014
Information provided by (Responsible Party):
Dentsply Sirona Implants

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.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Device: OsseoSpeed™ Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Study to Evaluate Buccal Bone Preservation Using Fixture MicroThread™ OsseoSpeed™ Placed in Fresh Extraction Sockets the Maxilla.
Study Start Date : December 2005
Actual Primary Completion Date : June 2011

Arm Intervention/treatment
Experimental: A Device: OsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.
Experimental: B Device: OsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 4.5 and 5.0 mm.

Primary Outcome Measures :
  1. Clinical measure of the thickness of the facial bone wall. [ Time Frame: At implant placement and after 16 weeks of healing. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00711282

Studio Odontoiatrico
Padova, Italy, 351 25
Department of Periodontics, Faculty of Odontology, Universidad Complutense de Madrid
Madrid, Spain, 28040
Department of Periodontology, School of Dental Medicine, University of Berne
Berne, Switzerland, CH-3010
Sponsors and Collaborators
Dentsply Sirona Implants

Publications of Results:

Responsible Party: Dentsply Sirona Implants Identifier: NCT00711282     History of Changes
Other Study ID Numbers: YA-OSS-0009
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: June 2014

Keywords provided by Dentsply Sirona Implants:
Replacement of non-restorable single tooth/teeth

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases