- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00346944
Health Effects From Removal of Amalgam Restorations in Patients With Symptoms Allegedly Related to Dental Amalgam
August 27, 2012 updated by: Lars Bjorkman, University of Bergen
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bergen, Norway, NO-5009
- UNIFOB AS, Dental Biomaterials Adverse Reaction Unit
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Referred for examination of general health complaints related to amalgam
- Health complaints from at least three different organ systems
- Dental amalgam restorations present
- Data available on concentration of mercury in blood and urine at the initial examination
- Patient agreed to be contacted after the examination
Exclusion Criteria:
- Serious disease (incl. severe allergy to foodstuff and severe rheumatoid arthritis)
- Mental instability or psychiatric disease
- Cases with complicated dental rehabilitation (incl. bridge prostheses)
- Allergy to dental replacement materials
- Severe periodontitis
- High caries activity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
|
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.
|
No Intervention: Reference group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes of subjective health complaints
Time Frame: Five years
|
Five years
|
Changes over time of the MMPI-profile
Time Frame: Five years
|
Five years
|
Quality of life improvement
Time Frame: Five years
|
Five years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of mercury in blood serum
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lars Björkman, DDS, PhD, University of Bergen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Björkman L, Dalen K, Helland V. Clinical trial on health effects from removal of amalgam restorations. J Dent Res 84(Spec Iss A): 1192, 2005.
- Sjursen TT, Lygre GB, Dalen K, Helland V, Laegreid T, Svahn J, Lundekvam BF, Bjorkman L. Changes in health complaints after removal of amalgam fillings. J Oral Rehabil. 2011 Nov;38(11):835-48. doi: 10.1111/j.1365-2842.2011.02223.x. Epub 2011 Apr 23.
- Lygre GB, Sjursen TT, Svahn J, Helland V, Lundekvam BF, Dalen K, Bjorkman L. Characterization of health complaints before and after removal of amalgam fillings--3-year follow-up. Acta Odontol Scand. 2013 May-Jul;71(3-4):560-9. doi: 10.3109/00016357.2012.697577. Epub 2012 Jul 2.
- Bjorkman L, Brokstad KA, Moen K, Jonsson R. Minor changes in serum levels of cytokines after removal of amalgam restorations. Toxicol Lett. 2012 Jun 1;211(2):120-5. doi: 10.1016/j.toxlet.2012.03.769. Epub 2012 Mar 28.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
June 29, 2006
First Submitted That Met QC Criteria
June 29, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Estimate)
August 28, 2012
Last Update Submitted That Met QC Criteria
August 27, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- REK III 24.01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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