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Completed

NCT Number: NCT00346944

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

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.

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Key information

Conditions

Adverse Effects Dental Restoration, Permanent

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UNIFOB AS, Dental Biomaterials Adverse Reaction Unit

Bergen, NO-5009, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Removal of dental amalgam restorations

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.

Primary outcomes

  1. Changes of subjective health complaints

    Time frame: Five years

  2. Changes over time of the MMPI-profile

    Time frame: Five years

  3. Quality of life improvement

    Time frame: Five years

Secondary outcomes

  1. Reduction of mercury in blood serum

    Time frame: One year

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • NORCE Norwegian Research Centre AS

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Jul 4, 2006
Registry last updated
Aug 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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