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 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/1998 |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Munich Technical University - Centre for Complementary Medicine Research (Germany)
University/education
University/education
Dept. Internal Medicine II
Technical University Munich
Kaiserstr. 9
Munich
80801
Germany
| Phone | +49 (0)89 72669711 |
|---|---|
| Dieter.Melchart@lrz.tu-muenchen.de | |
"ROR" |
https://ror.org/02kkvpp62 |
Funders
Funder type
Research organisation
German Association of Foundations for Science (Stifterverband der Deutschen Wissenschaft) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
