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NCT00346944 Clinical Trial

Health Effects From Removal of Amalgam Restorations in Patients With Symptoms Allegedly Related to Dental Amalgam

Adverse Effects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00346944
Other study ID # REK III 24.01
Secondary ID
Status Completed
Phase Phase 4
First received June 29, 2006
Last updated August 27, 2012
Start date September 2002
Est. completion date March 2010

Study information
Verified date August 2012
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority Norway: Directorate of Health
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 55 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• 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.

Locations
Country Name City State
Norway UNIFOB AS, Dental Biomaterials Adverse Reaction Unit Bergen

Sponsors (2)
Lead Sponsor Collaborator
University of Bergen Uni Research

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Björkman 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. — View Citation

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.

Lygre GB, Sjursen TT, Svahn J, Helland V, Lundekvam BF, Dalen K, Björkman 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: 10.3109/00016357.2012.6 — View Citation

Sjursen TT, Lygre GB, Dalen K, Helland V, Laegreid T, Svahn J, Lundekvam BF, Björkman 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Changes of subjective health complaints Five years Yes
Primary Changes over time of the MMPI-profile Five years Yes
Primary Quality of life improvement Five years Yes
Secondary Reduction of mercury in blood serum One year No
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