Application of molecular diagnostic methodologies to analyse plaque microbial population shifts associated with placement of fixed orthodontic appliances
| ISRCTN | ISRCTN32707822 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32707822 |
| Secondary identifying numbers | N0264149440 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 16/03/2018
- 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
Not provided at time of registration
Contact information
Dr A Ireland
Scientific
Scientific
C/O Research & Effectiveness Department
Level 1, The Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 928 3473 |
|---|---|
| r&eoffice@ubht.swest.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Application of molecular diagnostic methodologies to analyse plaque microbial population shifts associated with placement of fixed orthodontic appliances |
| Study hypothesis | Are there shifts from non-pathological to pathological bacterial flora following the placement of fixed orthodontic appliances (braces) |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Oral Health: Orthodontics |
| Intervention | Placement of fixed appliances (braces) - randomised cross mouth allocation of bands |
| Intervention type | Other |
| Primary outcome measure | Changes in the oral microflora, both sub and supra gingival, as a result of orthodontic fixed appliance treatment (braces) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2005 |
| Overall study end date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 25 |
| Participant inclusion criteria | 25 patients aged 11-14 years about to start treatment with fixed orthodontic appliances |
| Participant exclusion criteria | 1. Patients requiring dental arch expansion 2. Heavily restored dentition 3. Use of antibiotics in the last 3 months |
| Recruitment start date | 01/01/2005 |
| Recruitment end date | 01/01/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
United Bristol Healthcare NHS Trust
No information available
NHS R&D Support Funding
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 | 01/05/2014 | Yes | No |
Editorial Notes
16/03/2018: Publication reference added.
