Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery

Stopped early · Not applicable

Conditions studied: Jaw, Edentulous, Poor Bone Quality

In brief

The primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro). 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

NCT00748670

Run by

Dentsply Sirona Implants and Consumables

People needed

23

Starts

1999-09-01

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
• Bone quality class III or IV, (according to Lekholm \& Zarb16)
• Willing to give signed informed consent

You may not qualify if…

• Need for bone augmentation of the maxilla
• Tobacco smoking more than 5 cigarettes/day
• 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
• Bruxism or other parafunctional activity

Where it is running

• University of Iowa, College of Dentistry, Dow's Institute for Dental Research — Iowa City, Iowa, United States
• Specialisttandvården, Avd för Oral Protetik, Länssjukhuset Gävle-Sandviken — Gävle, Sweden
• Odontologiska kliniken, Länssjukhuset — Halmstad, Sweden

Full record on ClinicalTrials.gov

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