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

Not Applicable

Terminated

• Conditions: Jaw, Edentulous; Poor Bone Quality
• Interventions: Device: Fixture MicroThread (Micro-Macro)

• Registration Number: NCT00748670
• Lead Sponsor: Dentsply Sirona Implants and Consumables

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-09
• Primary Completion: 2006-10
• Status Verified: 2008-09
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Last Update Submitted: 2008-09-05
• Study First Posted: 2008-09-08
• Last Update Posted: 2008-09-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• 18 - 75 years of age
• Bone quality class III or IV, (according to Lekholm & Zarb16)
• Willing to give signed informed consent

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Fixture MicroThread (Micro-Macro)	-

Primary Outcome Measures

Name	Time	Method
Implant survival	Continuously during 5,5 years after implant placement

Trial Locations

Locations (3)

Specialisttandvården, Avd för Oral Protetik, Länssjukhuset Gävle-Sandviken; 🇸🇪 Gävle, Sweden

University of Iowa, College of Dentistry, Dow's Institute for Dental Research; 🇺🇸 Iowa City, Iowa, United States

Odontologiska kliniken, Länssjukhuset; 🇸🇪 Halmstad, Sweden