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

NCT ID: NCT00748241

Last Updated: 2012-02-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Brief Summary

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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

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Conditions

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Jaw, Edentulous, Partially

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Astra Tech Fixture ST

Group Type EXPERIMENTAL

Astra Tech Fixture ST

Intervention Type DEVICE

Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce G Valauri, D.D.S.

Role: PRINCIPAL_INVESTIGATOR

New York Dept of Veterans Affairs Medical Center

Michael Toffler, D.D.S.

Role: PRINCIPAL_INVESTIGATOR

New York Dept of Veterans Affairs Medical Center

Locations

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

New York, New York, United States

Site Status

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

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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YA-MIC-0002

Identifier Type: -

Identifier Source: org_study_id

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