Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later

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.
 
ClinicalTrials.gov Identifier: NCT00711425
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : September 26, 2011
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):
Dentsply Sirona Implants

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior mandible in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Prospective Study to Evaluate Implant Stability, Marginal Bone Adaptation and the Survival Rate of Astra Tech Dental Implant System, Fixture Osseospeed™, in Patients With Tooth Loss in the Posterior Mandible in an Early Loading Protocol.
Study Start Date : February 2004
Actual Primary Completion Date : January 2010
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: A Device: OsseoSpeed™
OsseoSpeed™, all dimensions


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Implant Survival Rate [ Time Frame: At 5 year follow-up ]
    An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.

  2. Implant Stability [ Time Frame: At 1 year follow-up ]
    Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.

  3. Marginal Bone Adaptation [ Time Frame: At 5 year follow-up ]
    Marginal bone adaptation will be expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • 18 years of age and over
  • Edentulous in the posterior mandible, Kennedy class I or class II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
  • Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading

Exclusion Criteria:

  • Untreated caries and/or periodontal disease of residual dentition
  • History of edentulism in the area of implant placement of less than two months
  • Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
  • History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
  • Any 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
  • Present alcohol or drug abuse
  • Unable or unwilling to return for follow-up visits for a period of 5 years
  • Current use of smoking tobacco
  • Pregnancy or lactation at the time of enrollment
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT00711425


Locations
Layout table for location information
United States, Ohio
The Ohio State University, College of Dentistry
Columbus, Ohio, United States, 43210-1241
United States, Washington
University of Washington, Dept. of Restorative Dentistry
Seattle, Washington, United States, 98195
Germany
Georg-August-Universität, Göttingen, Abt. Mund-, Keifer-, und Gesicthschirurgie
Göttingen, Germany, 37075
Sponsors and Collaborators
Dentsply Sirona Implants
Investigators
Layout table for investigator information
Principal Investigator: Edwin A McGlumphy, D.D.S. The Ohio State University, College of Dentistry
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Dentsply Sirona Implants
ClinicalTrials.gov Identifier: NCT00711425    
Other Study ID Numbers: YA-OSS-0002
First Posted: July 8, 2008    Key Record Dates
Results First Posted: September 26, 2011
Last Update Posted: September 9, 2013
Last Verified: August 2013
Keywords provided by Dentsply Sirona Implants:
Jaw, Edentulous, Partially (posterior mandible)
Additional relevant MeSH terms:
Layout table for MeSH terms
Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Mouth Diseases
 Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases