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

Primary Purpose

Jaw, Edentulous, Poor Bone Quality

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Fixture MicroThread (Micro-Macro)
Sponsored by
Dentsply Sirona Implants and Consumables
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

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

First Posted
September 5, 2008
Last Updated
September 5, 2008
Sponsor
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT00748670
Brief Title
Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery
Official Title
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
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
September 1999 (undefined)
Primary Completion Date
October 2006 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Poor Bone Quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clark Stanford, D.D.S., Ph.D.
Organizational Affiliation
University of Iowa, College of Dentistry, Dow's Institute for Dental Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa, College of Dentistry, Dow's Institute for Dental Research
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1010
Country
United States
Facility Name
Specialisttandvården, Avd för Oral Protetik, Länssjukhuset Gävle-Sandviken
City
Gävle
ZIP/Postal Code
801 87
Country
Sweden
Facility Name
Odontologiska kliniken, Länssjukhuset
City
Halmstad
ZIP/Postal Code
301 85
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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