NCT00748670

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

An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With an Implant-Supported Prosthesis Retained by Astra Tech Dental Implants, Fixture Micro-Macro in Patients With Poor Bone Quality

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Dentsply Sirona Implants and Consumables · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Jaw, Edentulous
• Poor Bone Quality

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 1999-09-01
• Primary completion: 2006-10-01
• First posted: 2008-09-08
• Last updated: 2008-09-08

Locations

3 sites across 2 countries: United States, Sweden