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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:
ClinicalTrials.gov Identifier:
NCT00748241
First Posted: September 8, 2008
Last Update Posted: February 15, 2012
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.
Information provided by (Responsible Party):
Dentsply Sirona Implants
  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: Intervention Model: Single Group Assignment
Masking: None (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 Sirona Implants:

Primary Outcome Measures:
  • Implant Survival Rate [ Time Frame: At follow-up visit: 6 months after implants have been loaded ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00748241


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

Responsible Party: Dentsply Sirona Implants
ClinicalTrials.gov Identifier: NCT00748241     History of Changes
Other Study ID Numbers: YA-MIC-0002
First Submitted: September 5, 2008
First Posted: September 8, 2008
Results First Submitted: August 23, 2011
Results First Posted: February 15, 2012
Last Update Posted: February 15, 2012
Last Verified: January 2012

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