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

Study Overview
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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.

Official Title
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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

Conditions
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Adverse Effects, Dental Restoration, Permanent

Intervention / Treatment
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* Procedure: Removal of dental amalgam restorations


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br> | Procedure: Removal of dental amalgam restorations<br>* 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.<br>|
| No Intervention: Reference group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of subjective health complaints |  | Five years | 
| Changes over time of the MMPI-profile |  | Five years | 
| Quality of life improvement |  | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of mercury in blood serum |  | One year |