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

Stopped early · Not applicable

Conditions studied: Jaw, Edentulous

In brief

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.

Key facts

Study ID

NCT00748397

Run by

Dentsply Sirona Implants and Consumables

People needed

54

Starts

1999-01-01

Last updated by the study team

2008-09-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Louisiana State University Medical Center, School of Dentistry — New Orleans, Louisiana, United States
• Klinik und Poliklinik fur Mund- Kiefer- und Geschichtechirurgie, Ruprecht-Karls-Universität — Heidelberg, Germany
• Dpto. Medicina y Cirugia Bucofacial, Facultad de Odontologia — Madrid, Spain
• Käkkirurgiska kliniken, Universitetssjukhuset MAS — Malmö, Sweden

Full record on ClinicalTrials.gov

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