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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00748670
Other study ID # YA-MMF-0003
Secondary ID
Status Terminated
Phase N/A
First received September 5, 2008
Last updated September 5, 2008
Start date September 1999

Study information

Verified date September 2008
Source Dentsply Implants
Contact n/a
Is FDA regulated No
Health authority Sweden: 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 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.


Recruitment information / eligibility

Status Terminated
Enrollment 23
Est. completion date
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


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

Sponsors (1)

Lead Sponsor Collaborator
Dentsply Implants

Countries where clinical trial is conducted

United States,  Sweden, 

Outcome

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