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

Not Applicable

Completed

• Conditions: Jaw, Edentulous, Partially
• Interventions: Device: Astra Tech Fixture ST

• Registration Number: NCT00748241
• Lead Sponsor: Dentsply Sirona Implants and Consumables

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2008-08
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-08
• Results First Submitted: 2011-08-23
• Status Verified: 2012-01
• Results First Submitted QC: 2012-01-12
• Last Update Submitted: 2012-01-12
• Results First Posted: 2012-02-15
• Last Update Posted: 2012-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Astra Tech Fixture ST	Astra Tech Fixture ST	-

Primary Outcome Measures

Name	Time	Method
Implant Survival Rate	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

Name	Time	Method
Implant Failure	3 years after implant placement	Total number of implants reported as failure.

Trial Locations

Locations (2)

Dept. of Prosthodontics, New York Dept of Veterans Affairs Medical Center; 🇺🇸 New York, New York, United States

Dept. of Periodontology, New York Dept of Veterans Affairs Medical Center; 🇺🇸 New York, New York, United States