Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 7, 2008
August 22, 2013
February 2004
January 2010   (final data collection date for primary outcome measure)
  • 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.
Implant Survival Rate [ Time Frame: From implant placement until 5-year follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00711425 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Jaw, Edentulous, Partially
Device: OsseoSpeed™
OsseoSpeed™, all dimensions
Experimental: A
Intervention: Device: OsseoSpeed™
Schliephake H, Rödiger M, Phillips K, McGlumphy EA, Chacon GE, Larsen P. Early loading of surface modified implants in the posterior mandible - 5 year results of an open prospective non-controlled study. J Clin Periodontol. 2012 Feb;39(2):188-95. doi: 10.1111/j.1600-051X.2011.01816.x. Epub 2011 Nov 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
Not Provided
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00711425
YA-OSS-0002
No
Dentsply Implants
Dentsply Implants
Not Provided
Principal Investigator: Edwin A McGlumphy, D.D.S. The Ohio State University, College of Dentistry
Dentsply Implants
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP