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Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00748241
First received: September 5, 2008
Last updated: January 12, 2012
Last verified: January 2012

September 5, 2008
January 12, 2012
September 2000
August 2008   (final data collection date for primary outcome measure)
  • Implant Survival Rate [ Time Frame: At follow-up visit: 6 months after implants have been loaded ] [ 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. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
  • Implant Survival Rate [ Time Frame: At follow-up visit: 1 year after implants have been loaded ] [ 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. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
  • Implant Survival Rate [ Time Frame: At follow-up visit: 2 years after implants have been loaded ] [ 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. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
  • Implant Survival Rate [ Time Frame: At follow-up visit: 3 years after implants have been loaded ] [ 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. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.
Implant survival rate [ Time Frame: At follow-up visits: 6 months, 1 year, 2 and 3 years after implants have been loaded ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00748241 on ClinicalTrials.gov Archive Site
Implant Failure [ Time Frame: 3 years after implant placement ] [ Designated as safety issue: No ]
Total number of implants reported as failure.
Not Provided
Not Provided
Not Provided
 
Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading
An Open Prospective Study to Evaluate the Survival Rate and Marginal Bone Response of Astra Tech Dental Implants, Fixture ST, in Patients With Tooth Loss in the Posterior Maxilla.

The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Jaw, Edentulous, Partially
Device: Astra Tech Fixture ST
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Experimental: Astra Tech Fixture ST
Intervention: Device: Astra Tech Fixture ST
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
Not Provided
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 - 75
  • Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid
  • Willing to give informed consent

Exclusion Criteria:

  • Bone height < 5 mm, in the planned implant area
  • Bone width < 5 mm, in the planned implant area
  • Previous bone augmentation procedure in the planned implant area
  • Previous failures of endosseous implants
  • Untreated caries and/or periodontal disease of residual dentition
  • History or presence of any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
  • Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
  • Current alcohol or drug abuse
  • Unable or unwilling to return for follow-up visits for 3 years
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00748241
YA-MIC-0002
No
Dentsply Implants
Dentsply Implants
Not Provided
Principal Investigator: Bruce G Valauri, D.D.S. New York Dept of Veterans Affairs Medical Center
Principal Investigator: Michael Toffler, D.D.S. New York Dept of Veterans Affairs Medical Center
Dentsply Implants
January 2012

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