An investigation of odontogenic bacteraemia associated with orthodontic treatment procedures
| ISRCTN | ISRCTN27557210 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27557210 |
| Secondary identifying numbers | N0263092953 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 06/01/2009
- 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 VS Lucas
Scientific
Scientific
Oral Surgery Department
Eastman Dental Hospital
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom
| Phone | +44 (0)20 7915 1000 |
|---|
Study information
| Study design | Randomised single blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | There may be an increase in the prevalence and intensity of bacteraemia following either debanding or gold chain adjustment, compared with baseline. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health: Orthodontics |
| Intervention | 1. Debanding 2. Adjustment of a gold chain and bracket |
| Intervention type | Other |
| Primary outcome measure | 1. Prevalence of bacteraemia (number of positive blood cultures) 2. Intensity of bacteraemia (number of colony forming units of bacteria per ml blood) 3. Identity of bacteria isolated from blood cultures |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/2002 |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 82 |
| Key inclusion criteria | 82 patients from Paediatric Dentistry. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/2002 |
| Date of final enrolment | 01/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oral Surgery Department
London
WC1X 8LD
United Kingdom
WC1X 8LD
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University College London Hospitals NHS Trust (UK)
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 | 01/04/2007 | Yes | No |
