Adverse EffectsPhase 4NCT00346944
Health Effects From Removal of Amalgam Restorations in Patients With Symptoms Allegedly Related to Dental Amalgam
A Phase 4 study testing Removal of dental amalgam restorations in people with Adverse Effects and Dental Restoration, Permanent, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Adverse Effects, Dental Restoration, Permanent
- What is being tested?
- Removal of dental amalgam restorations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2002to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Norway1 site
UNIFOB AS, Dental Biomaterials Adverse Reaction Unit
Bergen, NO-5009
About this 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
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.
Read the 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.
- Conditions
- Adverse Effects, Dental Restoration, Permanent
- Being tested
- Removal of dental amalgam restorations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of dental amalgam restorationsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Procedure: Removal of dental amalgam restorations |
| Reference group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of subjective health complaints
Measured: Five years
Changes over time of the MMPI-profile
Measured: Five years
Quality of life improvement
Measured: Five years
Secondary outcomes (1)
Reduction of mercury in blood serum
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startSep 2002
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adverse EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- NORCE Norwegian Research Centre AS
- Responsible party
- Principal investigator, Lars Bjorkman, NORCE Norwegian Research Centre AS
- Investigators
- Lars Björkman, DDS, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346944
- Sponsor's protocol ID
- REK III 24.01
- Status last verified
- Aug 2012
- First submitted
- 29 Jun 2006
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
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.
PubMed 21517933Lygre 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.
PubMed 22746255Bjorkman 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.
PubMed 22475563
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00346944
- Acronym / sponsor ID
- REK III 24.01
- Conditions
- Adverse Effects, Dental Restoration, Permanent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- NORCE Norwegian Research Centre AS
- Study start
- Sep 2002
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Procedure: Removal of dental amalgam restorations |
| Reference group | No intervention | – |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removal of dental amalgam restorationsRemoval 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. | Procedure or surgery | Treatment group |
Primary outcome
Changes of subjective health complaints
Time frame: Five years
Changes over time of the MMPI-profile
Time frame: Five years
Quality of life improvement
Time frame: Five years
1 secondary outcome
Reduction of mercury in blood serum
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
- BackgroundBjörkman L, Dalen K, Helland V. Clinical trial on health effects from removal of amalgam restorations. J Dent Res 84(Spec Iss A): 1192, 2005.
- Results publication: PubMed 21517933Sjursen 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.
- Results publication: PubMed 22746255Lygre 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.
- Results publication: PubMed 22475563Bjorkman 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.
Related trials for Adverse Effects
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Björkman, DDS, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Removal of dental amalgam restorations in people with Adverse Effects and Dental Restoration, Permanent, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of subjective health complaints (time frame: Five years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00346944, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2012.