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

NCT ID: NCT00346944

Last Updated: 2012-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Adverse Effects Dental Restoration, Permanent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Group Type EXPERIMENTAL

Removal of dental amalgam restorations

Intervention Type PROCEDURE

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.

Reference group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NORCE Norwegian Research Centre AS

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Lars Bjorkman

Principal Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Björkman, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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UNIFOB AS, Dental Biomaterials Adverse Reaction Unit

Bergen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND

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.

Reference Type RESULT
PMID: 21517933 (View on PubMed)

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.

Reference Type RESULT
PMID: 22746255 (View on PubMed)

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.

Reference Type RESULT
PMID: 22475563 (View on PubMed)

Other Identifiers

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REK III 24.01

Identifier Type: -

Identifier Source: org_study_id