An investigation of odontogenic bacteraemia associated with orthodontic treatment procedures
| ISRCTN | ISRCTN27557210 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27557210 |
| Protocol serial number | N0263092953 |
| Sponsor | Department of Health (UK) |
| Funder | University College London Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised single blind study |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Prevalence of bacteraemia (number of positive blood cultures) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Oral Surgery Department
London
WC1X 8LD
United Kingdom
WC1X 8LD
United Kingdom
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 | 01/04/2007 | Yes | No |
