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Prospective Cohort Study of Health Complaints

NCT01682278 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 118

Last updated 2022-03-31

No results posted yet for this study

Summary

The aim of this study is to evaluate if amalgam removal is associated with improved self-reported health, compared to no amalgam removal. The main target group consists of a group of patients with medically unexplained physical symptoms (MUPS), which they attribute to dental amalgam restorations. The patients should furthermore express the wish to have these amalgam fillings removed. The project is designed as a prospective cohort study, consisting of three groups recruited separately. The main target group will be compared with two comparison groups: one group of patients with MUPS recruited from general practice and one group of healthy study patients, recruited at dental practice. The primary research question is if amalgam removal is associated with improved self-reported health, compared to no amalgam removal, one year after completed amalgam removal.

Conditions

  • Health Complaints Attributed to Dental Amalgam Restorations

Interventions

DEVICE

Removal of dental amalgam restorations

Patients in the "amalgam cohort" will have all dental amalgam restorations removed and replaced with other restorative materials used in modern dentistry. Amalgam removal will be performed by the patient's regular dentist or another dentist chosen by the patient.

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • National Research Centre of Complementary and Alternative Medicine, Norway

    collaborator OTHER

  • University of Witten/Herdecke

    collaborator OTHER

  • NORCE Norwegian Research Centre AS

    lead OTHER

Principal Investigators

  • Lars Björkman, PhD · NORCE Norwegian Research Centre AS

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2018-11-30
Completion
2021-06-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01682278 on ClinicalTrials.gov