Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage Surgery

NCT ID: NCT00748397

Last Updated: 2008-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Brief Summary

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The primary objective of the study is to evaluate the long-term survival rate of implants and prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro) using a one-stage surgical procedure.

Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.

Detailed Description

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Conditions

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Jaw, Edentulous

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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A

Group Type EXPERIMENTAL

Fixture MicroThread (Micro-Macro)

Intervention Type DEVICE

Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.

Interventions

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Fixture MicroThread (Micro-Macro)

Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18-75 years of age
* Sufficient amount of bone to give good support for implants of at least 9 mm length.
* Willing to give signed informed consent

Exclusion Criteria

* Any systemic 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
* Unable or unwilling to return for follow-up visits
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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Astra Tech AB

Principal Investigators

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Bo Sunzel, Dr

Role: PRINCIPAL_INVESTIGATOR

Käkkirurgiska kliniken, Universitetssjukhuset MAS

Locations

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Louisiana State University Medical Center, School of Dentistry

New Orleans, Louisiana, United States

Site Status

Klinik und Poliklinik fur Mund- Kiefer- und Geschichtechirurgie, Ruprecht-Karls-Universität

Heidelberg, , Germany

Site Status

Dpto. Medicina y Cirugia Bucofacial, Facultad de Odontologia

Madrid, , Spain

Site Status

Käkkirurgiska kliniken, Universitetssjukhuset MAS

Malmo, , Sweden

Site Status

Countries

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United States Germany Spain Sweden

Other Identifiers

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YA-MMF-0002

Identifier Type: -

Identifier Source: org_study_id