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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00748241
Other study ID # YA-MIC-0002
Secondary ID
Status Completed
Phase N/A
First received September 5, 2008
Last updated January 12, 2012
Start date September 2000

Study information

Verified date January 2012
Source Dentsply Implants
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Dept. of Periodontology, New York Dept of Veterans Affairs Medical Center New York New York
United States Dept. of Prosthodontics, New York Dept of Veterans Affairs Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Dentsply Implants

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implant Survival Rate 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. At follow-up visit: 6 months after implants have been loaded No
Primary Implant Survival Rate 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. At follow-up visit: 1 year after implants have been loaded No
Primary Implant Survival Rate 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. At follow-up visit: 2 years after implants have been loaded No
Primary Implant Survival Rate 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. At follow-up visit: 3 years after implants have been loaded No
Secondary Implant Failure Total number of implants reported as failure. 3 years after implant placement No
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