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

Jaw, Edentulous Clinical Trial

Official title:

An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With Fixed Detachable Bridges Retained by Astra Tech Dental Implants, Fixture Micro-Macro

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00748397
• Other study ID #: YA-MMF-0002
• Status: Terminated
• Phase: N/A
• First received: September 5, 2008
• Last updated: September 5, 2008
• Start date: January 1999

Study information

• Verified date: September 2008
• Source: Dentsply Implants
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionSpain: Comité Ético de Investigación ClínicaSweden: Regional Ethical Review BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Mouth, Edentulous

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Implants

Countries where clinical trial is conducted

United States,  Germany,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival		Continuously during 5,5 years after implant placement	No