NCT00346944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

August 28, 2012

Status Verified

August 1, 2012

Enrollment Period

7.5 years

First QC Date

June 29, 2006

Last Update Submit

August 27, 2012

Conditions

Adverse EffectsDental Restoration, Permanent

Outcome Measures

Primary Outcomes (3)

  • Changes of subjective health complaints

    Five years

  • Changes over time of the MMPI-profile

    Five years

  • Quality of life improvement

    Five years

Secondary Outcomes (1)

  • Reduction of mercury in blood serum

    One year

Study Arms (2)

Treatment group

EXPERIMENTAL
Procedure: Removal of dental amalgam restorations

Reference group

NO INTERVENTION

Interventions

Removal of dental amalgam restorationsPROCEDURE

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.

Treatment group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNIFOB AS, Dental Biomaterials Adverse Reaction Unit

Bergen, NO-5009, Norway

Location

Related Publications (4)

  • 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.

    BACKGROUND

  • Sjursen TT, Lygre GB, Dalen K, Helland V, Laegreid T, Svahn J, Lundekvam BF, Bjorkman L. Changes in health complaints after removal of amalgam fillings. J Oral Rehabil. 2011 Nov;38(11):835-48. doi: 10.1111/j.1365-2842.2011.02223.x. Epub 2011 Apr 23.

    PMID: 21517933RESULT

  • Lygre GB, Sjursen TT, Svahn J, Helland V, Lundekvam BF, Dalen K, Bjorkman L. Characterization of health complaints before and after removal of amalgam fillings--3-year follow-up. Acta Odontol Scand. 2013 May-Jul;71(3-4):560-9. doi: 10.3109/00016357.2012.697577. Epub 2012 Jul 2.

    PMID: 22746255RESULT

  • Bjorkman L, Brokstad KA, Moen K, Jonsson R. Minor changes in serum levels of cytokines after removal of amalgam restorations. Toxicol Lett. 2012 Jun 1;211(2):120-5. doi: 10.1016/j.toxlet.2012.03.769. Epub 2012 Mar 28.

    PMID: 22475563RESULT

Study Officials

  • Lars Björkman, DDS, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Researcher

Study Record Dates

First Submitted

June 29, 2006

First Posted

July 4, 2006

Study Start

September 1, 2002

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

August 28, 2012

Record last verified: 2012-08

Locations

NO(1)