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

Jaw, Edentulous, Partially Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748241
• Other study ID #: YA-MIC-0002
• 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. 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

• Jaw, Edentulous
• Jaw, Edentulous, Partially

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