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

Tracking Information

First Received Date ^ICMJE

June 29, 2006

Last Updated Date

November 12, 2008

Start Date ^ICMJE

September 2002

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Changes of subjective health complaints
Changes over time of the MMPI-profile
Quality of life improvement

Change History

Complete list of historical versions of study NCT00346944 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Reduction of mercury in blood serum

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Adverse Effects
Dental Restoration, Permanent

Intervention ^ICMJE

Device: Removal of dental amalgam restorations

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

August 2010

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00346944

Responsible Party

Lars Björkman/Head Dental Biomaterials Adverse Reaction Unit, UNIFOB AS

Study ID Numbers ^ICMJE

REK III 24.01

Study Sponsor ^ICMJE

University of Bergen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Lars Björkman, DDS, PhD

University of Bergen

Information Provided By

University of Bergen

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP