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:

Information provided by (Responsible Party):

Dentsply Implants

ClinicalTrials.gov Identifier:

NCT00748241

First received: September 5, 2008

Last updated: January 12, 2012

Last verified: January 2012

History of Changes

Results First Received: August 23, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Jaw, Edentulous, Partially
Intervention:	Device: Astra Tech Fixture ST

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Astra Tech Fixture ST
STARTED	19
COMPLETED	11
NOT COMPLETED	8
Implant failure	1
Lost to Follow-up	5
Death	2

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	Astra Tech Fixture ST
Number of Participants [units: participants]	19
Age [units: years] Mean ± Standard Deviation	61.0 ± 11.3
Gender [units: participants]
Female	2
Male	17
Region of Enrollment [units: participants]
United States	19

Outcome Measures

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1. Primary:

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

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2. Primary:

Implant Survival Rate [ Time Frame: At follow-up visit: 1 year after implants have been loaded ]

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3. Primary:

Implant Survival Rate [ Time Frame: At follow-up visit: 2 years after implants have been loaded ]

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Measure Type	Primary
Measure Title	Implant Survival Rate
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Population includes subjects who completed 24 month visit.

Reporting Groups

	Description
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.

Measured Values

	Astra Tech Fixture ST
Number of Participants Analyzed [units: participants]	13
Number of Implants Analyzed [units: Implants]	43
Implant Survival Rate [units: Percentage of implants]	89.9

No statistical analysis provided for Implant Survival Rate

4. Primary:

Implant Survival Rate [ Time Frame: At follow-up visit: 3 years after implants have been loaded ]

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5. Secondary:

Implant Failure [ Time Frame: 3 years after implant placement ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Head of Clinical Research Area Dental
Organization: Astra Tech AB
phone: +46317763000

No publications provided

Responsible Party:	Dentsply Implants
ClinicalTrials.gov Identifier:	NCT00748241 History of Changes
Other Study ID Numbers:	YA-MIC-0002
Study First Received:	September 5, 2008
Results First Received:	August 23, 2011
Last Updated:	January 12, 2012
Health Authority:	United States: Food and Drug Administration

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