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Sponsored by: |
University of Bergen |
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Information provided by: | University of Bergen |
ClinicalTrials.gov Identifier: | NCT00346944 |
The aim of the project is to study changes in symptom load after removal of all dental amalgam restorations in patients with symptoms allegedly related to amalgam.
Condition | Intervention | Phase |
---|---|---|
Adverse Effects Dental Restoration, Permanent |
Device: Removal of dental amalgam restorations |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Health Effects From Removal of Amalgam Restorations in Patients With Symptoms Allegedly Related to Dental Amalgam - A Study of Patients Examined at the Dental Biomaterials Adverse Reaction Unit in 1993 to 1999 |
Enrollment: | 50 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Treatment group: Experimental |
Device: Removal of dental amalgam restorations
Removal of dental amalgam restorations by patient's own dentist. Fillings will be replaced with e.g. resin based filling material, metalloceramic restorations, and ceramic materials. Rubber dam will be used during removal of amalgam restorations.
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Reference group: No Intervention |
Patients referred from dentists and physicians in the period 1993 to 1999 to the Dental Biomaterials Adverse Reaction Unit, Department of Health, UNIFOB AS, for symptoms related to amalgam restorations are randomized into treatment group (n=20) or reference group (n=20). All patients in the treatment group are followed 3, 12, 36 and 60 months after completion of amalgam removal with questionnaires on health outcomes, Minnesota Multiphasic Personality Inventory-2 (MMPI-2) and laboratory tests.
Ages Eligible for Study: | 25 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Norway | |
UNIFOB AS, Dental Biomaterials Adverse Reaction Unit | |
Bergen, Norway, NO-5009 |
Principal Investigator: | Lars Björkman, DDS, PhD | University of Bergen |
Responsible Party: | UNIFOB AS ( Lars Björkman/Head Dental Biomaterials Adverse Reaction Unit ) |
Study ID Numbers: | REK III 24.01 |
Study First Received: | June 29, 2006 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00346944 |
Health Authority: | Norway: Directorate for Health and Social Affairs |