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

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Dentsply

Status

Terminated

Conditions

Jaw, Edentulous

Treatments

Device: Fixture MicroThread (Micro-Macro)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00748397
YA-MMF-0002

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

54 participants in 1 patient group

A
Experimental group
Treatment:
Device: Fixture MicroThread (Micro-Macro)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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