Clinical trial NCT00346944: Health Effects From Removal of Amalgam Restorations in Patients With Symptoms Allegedly Related to Dental Amalgam
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adverse Effects
Dental Restoration, Permanent
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: NORCE Norwegian Research Centre AS
First posted: 2006-07-04
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of subjective health complaints
timeFrame: Five years
measure: Changes over time of the MMPI-profile
timeFrame: Five years
measure: Quality of life improvement
timeFrame: Five years
Secondary outcomes:
measure: Reduction of mercury in blood serum
timeFrame: One year
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: UNIFOB AS, Dental Biomaterials Adverse Reaction Unit
Study officials:
affiliation: University of Bergen
name: Lars Björkman, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
citation: 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.