NCT00748670

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
Last Updated

September 8, 2008

Status Verified

September 1, 2008

Enrollment Period

7.1 years

First QC Date

September 5, 2008

Last Update Submit

September 5, 2008

Conditions

Jaw, EdentulousPoor Bone Quality

Outcome Measures

Primary Outcomes (1)

  • Implant survival

    Continuously during 5,5 years after implant placement

Study Arms (1)

A

EXPERIMENTAL
Device: Fixture MicroThread (Micro-Macro)

Interventions

Fixture MicroThread (Micro-Macro)DEVICE

Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.

A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Iowa, College of Dentistry, Dow's Institute for Dental Research

Iowa City, Iowa, 52242-1010, United States

Location

Specialisttandvården, Avd för Oral Protetik, Länssjukhuset Gävle-Sandviken

Gävle, 801 87, Sweden

Location

Odontologiska kliniken, Länssjukhuset

Halmstad, 301 85, Sweden

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Clark Stanford, D.D.S., Ph.D.

    University of Iowa, College of Dentistry, Dow's Institute for Dental Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 8, 2008

Study Start

September 1, 1999

Primary Completion

October 1, 2006

Last Updated

September 8, 2008

Record last verified: 2008-09

Locations

US(1)SE(2)