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

U

University of Bergen

Status and phase

Completed
Phase 4

Conditions

Adverse Effects
Dental Restoration, Permanent

Treatments

Procedure: Removal of dental amalgam restorations

Study type

Interventional

Funder types

Other

Identifiers

NCT00346944
REK III 24.01

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

25 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Treatment group
Experimental group
Treatment:
Procedure: Removal of dental amalgam restorations
Reference group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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