A randomised controlled trial to compare three therapeutic interventions in patients with self-declared illnesses due to dental amalgam fillings
| ISRCTN | ISRCTN51459238 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51459238 |
| Protocol serial number | N/A |
| Sponsor | Munich Technical University - Centre for Complementary Medicine Research (Germany) |
| Funder | German Association of Foundations for Science (Stifterverband der Deutschen Wissenschaft) (Germany) |
- Submission date
- 10/02/2005
- Registration date
- 29/07/2005
- Last edited
- 10/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dieter Melchart
Scientific
Scientific
Centre for Complementary Medicine Research
Dept. Internal Medicine II
Technical University Munich
Kaiserstr. 9
Munich
80801
Germany
| Phone | +49 (0)89 72669711 |
|---|---|
| Dieter.Melchart@lrz.tu-muenchen.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | GAT (German Amalgam Trial) |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Symptoms attributed to amalgam fillings |
| Intervention | Group 1: Removal of amalgam fillings and restoration with composites and other dental materials Group 2: Removal of amalgam fillings and restoration with composites and other dental materials + mobilisation of mercury with complementary drug treatment Group 3: No removal of amalgam fillings; psychosocial group intervention |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | 90 patients with symptoms attributed to amalgam fillings |
| Key exclusion criteria | Patients with confirmed mental disorders or organic diseases were excluded |
| Date of first enrolment | 01/11/1998 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- Germany
Study participating centre
Centre for Complementary Medicine Research
Munich
80801
Germany
80801
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2008 | Yes | No |
