Health Effects From Removal of Amalgam Restorations in Patients With Symptoms Allegedly Related to Dental Amalgam - Full Text View

Sponsored by:	University of Bergen
Information provided by:	University of Bergen
ClinicalTrials.gov Identifier:	NCT00346944

Purpose

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.

Condition	Intervention	Phase
Adverse Effects Dental Restoration, Permanent	Device: Removal of dental amalgam restorations	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official 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

Further study details as provided by University of Bergen:

Primary Outcome Measures:

Changes of subjective health complaints [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
Changes over time of the MMPI-profile [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
Quality of life improvement [ Time Frame: Five years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Reduction of mercury in blood serum [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	September 2002
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment group: Experimental	Device: 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.
Reference group: No Intervention

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.

Eligibility

Ages Eligible for Study:	25 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346944

Locations

Norway
UNIFOB AS, Dental Biomaterials Adverse Reaction Unit
Bergen, Norway, NO-5009

Sponsors and Collaborators

University of Bergen

Investigators

Principal Investigator:

Lars Björkman, DDS, PhD

University of Bergen

More Information

Publications:

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.

Responsible Party:	UNIFOB AS ( Lars Björkman/Head Dental Biomaterials Adverse Reaction Unit )
Study ID Numbers:	REK III 24.01
Study First Received:	June 29, 2006
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00346944
Health Authority:	Norway: Directorate for Health and Social Affairs

ClinicalTrials.gov processed this record on January 14, 2009