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

Phase 4

Completed

• Conditions: Adverse Effects; Dental Restoration, Permanent
• Interventions: Procedure: Removal of dental amalgam restorations

• Registration Number: NCT00346944
• Lead Sponsor: University of Bergen

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2006-06-29
• Study First Submitted QC: 2006-06-29
• Study First Posted: 2006-07-04
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Treatment group	Removal of dental amalgam restorations	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Reduction of mercury in blood serum	One year

Trial Locations

Locations (1)

UNIFOB AS, Dental Biomaterials Adverse Reaction Unit; 🇳🇴 Bergen, Norway