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
  Purpose

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.


Condition Intervention
Jaw, Edentulous, Partially
Device: Astra Tech Fixture ST

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Implant Failure [ Time Frame: 3 years after implant placement ] [ Designated as safety issue: No ]
    Total number of implants reported as failure.


Enrollment: 19
Study Start Date: September 2000
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Astra Tech Fixture ST 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748241

Locations
United States, New York
Dept. of Prosthodontics, New York Dept of Veterans Affairs Medical Center
New York, New York, United States, 10010
Dept. of Periodontology, New York Dept of Veterans Affairs Medical Center
New York, New York, United States, 10010
Sponsors and Collaborators
Dentsply Implants
Investigators
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
  More Information

No publications provided

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00748241     History of Changes
Other Study ID Numbers: YA-MIC-0002
Study First Received: September 5, 2008
Results First Received: August 23, 2011
Last Updated: January 12, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014