Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage Surgery
Primary Purpose
Jaw, Edentulous
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Fixture MicroThread (Micro-Macro)
Sponsored by
About this trial
This is an interventional treatment trial for Jaw, Edentulous
Eligibility Criteria
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
Sites / Locations
- Louisiana State University Medical Center, School of Dentistry
- Klinik und Poliklinik fur Mund- Kiefer- und Geschichtechirurgie, Ruprecht-Karls-Universität
- Dpto. Medicina y Cirugia Bucofacial, Facultad de Odontologia
- Käkkirurgiska kliniken, Universitetssjukhuset MAS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Implant survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00748397
First Posted
September 5, 2008
Last Updated
September 5, 2008
Sponsor
Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT00748397
Brief Title
Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Terminated
Why Stopped
Decision to modify the product under study as a result of feedback regarding subjective feeling during installation procedure. For more info, see brief summary.
Study Start Date
January 1999 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Dentsply Sirona Implants and Consumables
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fixture MicroThread (Micro-Macro)
Intervention Description
Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.
Primary Outcome Measure Information:
Title
Implant survival
Time Frame
Continuously during 5,5 years after implant placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Sunzel, Dr
Organizational Affiliation
Käkkirurgiska kliniken, Universitetssjukhuset MAS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louisiana State University Medical Center, School of Dentistry
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119-2799
Country
United States
Facility Name
Klinik und Poliklinik fur Mund- Kiefer- und Geschichtechirurgie, Ruprecht-Karls-Universität
City
Heidelberg
Country
Germany
Facility Name
Dpto. Medicina y Cirugia Bucofacial, Facultad de Odontologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Käkkirurgiska kliniken, Universitetssjukhuset MAS
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage Surgery
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