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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

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Astra Tech Fixture ST
Sponsored by
Dentsply Sirona Implants and Consumables
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept. of Periodontology, New York Dept of Veterans Affairs Medical Center
  • Dept. of Prosthodontics, New York Dept of Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Astra Tech Fixture ST

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Implant Failure
Total number of implants reported as failure.

Full Information

First Posted
September 5, 2008
Last Updated
January 12, 2012
Sponsor
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT00748241
Brief Title
Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentsply Sirona Implants and Consumables

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Astra Tech Fixture ST
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Astra Tech Fixture ST
Intervention Description
Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
Primary Outcome Measure Information:
Title
Implant Survival Rate
Description
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.
Time Frame
At follow-up visit: 6 months after implants have been loaded
Title
Implant Survival Rate
Description
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.
Time Frame
At follow-up visit: 1 year after implants have been loaded
Title
Implant Survival Rate
Description
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.
Time Frame
At follow-up visit: 2 years after implants have been loaded
Title
Implant Survival Rate
Description
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.
Time Frame
At follow-up visit: 3 years after implants have been loaded
Secondary Outcome Measure Information:
Title
Implant Failure
Description
Total number of implants reported as failure.
Time Frame
3 years after implant placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce G Valauri, D.D.S.
Organizational Affiliation
New York Dept of Veterans Affairs Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Toffler, D.D.S.
Organizational Affiliation
New York Dept of Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Periodontology, New York Dept of Veterans Affairs Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Dept. of Prosthodontics, New York Dept of Veterans Affairs Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

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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

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