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OpenTrials
Completed

NCT Number: NCT02081664

Feasibility of an Integrated Medical Care Program for Patients With Continuing Health Complaints After Amalgam Removal

Some patients report relief of symptoms after amalgam removal. However, a large group of patients are still suffering from partly severe health complaints even after the removal of amalgam. To date, no biological/medical explanation for these Amalgam attributed health complaints is available.

The objective of this study is to develop an integrated medical care rehabilitation program and determine if it is a valid and feasible treatment for patients with persistent symptoms after amalgam removal. Such a comprehensive concept has to date not been operationalized in Norway, but information about the feasibility and the challenges around such a rehabilitation program are required, in order to prepare for a possible controlled and randomized study evaluating the effects of the suggested integrative care treatment program. This treatment program will focus on "learning by practicing", hence the study participants will be enrolled into a group program focusing on life-style changes. In addition to the life-style oriented group program, an individualized treatment strategy with therapies out of the spectrum of Complementary and Alternative Medicine (CAM) will be part of the treatment program. This part of the program is based on the results of a survey, related to use of CAM therapies, conducted in 2012 among the members of the patient organization "Forbundet Tenner og Helse".

Participants of this treatment program must amongst other inclusion criteria have removed all dental amalgam fillings and experience symptoms which have not disappeared after removal of the dental fillings. Specific exclusion criteria are stated. The group program consists of 12 sessions which are held once per week for a whole day. Added to this is a choice of CAM therapies from a hierarchic list, established from the survey, and which accordingly is based on risk/benefit judgment. Data collection will take place at baseline, after 12 weeks (end of treatment), and three month later. The aim of this study is to test the feasibility of an integrated medical care rehabilitation program for patients in Norway who have had their Amalgam fillings removed, but still suffer from Amalgam attributed symptoms. It combines a lifestyle oriented group program with individualized CAM therapies in form of an outpatient program.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tromsø

Tromsø, Troms, 9037, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The research population should be permanent residents in Norway and be between 20 to 70 years of age and able to comply with the protocol
  • Participants must have removed all dental amalgam fillings (screening by study dentist)
  • Still having health complaints which have not disappeared after removal of the dental amalgam fillings
  • Minimum duration of health complaints of 12 months since removal of the last amalgam filling
  • There is not yet any biological/medical explanation for their health complaints
  • Willing and motivated to take part in the IMCR program as it is described

Exclusion criteria

  • Patients with ongoing cancers, severe cardiopulmonal, neurological, or psychiatric diseases or mental retardation (screening by study GP)
  • Life threatening disease
  • Dental conditions requiring treatment before entering the program.

Treatment and study plan

Lifestyle Intervention

Behavioral

Primary outcomes

  1. achieved patient enrollment rates (number of patients eligible)

    Time frame: 8 weeks

    number of patients who are willing to participate and are eligible

Secondary outcomes

  1. MYMOP (scale from 0 to 6)

    Time frame: difference between baseline and 3 months

    MYMOP is a patient-generated instrument where patients themselves decide what their most relevant health complaint is.

Other outcomes

  1. MYMOP (scale from 0 to 6)

    Time frame: difference between baseline and 6 months

    MYMOP is a patient-generated instrument where patients themselves decide what their most relevant health complaint is.

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Registry information

Official study title

Development and Feasibility Assessment of an Integrated Medical Care Rehabilitation Program for Patients With Continuing Health Complaints After Amalgam Removal - The IMCR Trial

Acronym: IMCR

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 7, 2014
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.