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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00711425
First received: July 7, 2008
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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 Intervention
Jaw, Edentulous, Partially
Device: OsseoSpeed™

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Implant Survival Rate [ Time Frame: At 5 year follow-up ] [ Designated as safety issue: No ]
    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.

  • Implant Stability [ Time Frame: At 1 year follow-up ] [ Designated as safety issue: No ]
    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.

  • Marginal Bone Adaptation [ Time Frame: At 5 year follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 45
Study Start Date: February 2004
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: OsseoSpeed™
OsseoSpeed™, all dimensions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711425

Locations
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 Implants
Investigators
Principal Investigator: Edwin A McGlumphy, D.D.S. The Ohio State University, College of Dentistry
  More Information

Publications:
Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00711425     History of Changes
Other Study ID Numbers: YA-OSS-0002
Study First Received: July 7, 2008
Results First Received: June 7, 2011
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Ethics Commission

Keywords provided by Dentsply Implants:
Jaw, Edentulous, Partially (posterior mandible)

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

ClinicalTrials.gov processed this record on October 22, 2014