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 |
| Protocol serial number | N0264149440 |
| Sponsor | Department of Health |
| Funders | United Bristol Healthcare NHS Trust , NHS R&D Support Funding |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Application of molecular diagnostic methodologies to analyse plaque microbial population shifts associated with placement of fixed orthodontic appliances |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Oral Health: Orthodontics |
| Intervention | Placement of fixed appliances (braces) - randomised cross mouth allocation of bands |
| Intervention type | Other |
| Primary outcome measure(s) |
Changes in the oral microflora, both sub and supra gingival, as a result of orthodontic fixed appliance treatment (braces) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 14 Years |
| Sex | All |
| Target sample size at registration | 25 |
| Key inclusion criteria | 25 patients aged 11-14 years about to start treatment with fixed orthodontic appliances |
| Key exclusion criteria | 1. Patients requiring dental arch expansion 2. Heavily restored dentition 3. Use of antibiotics in the last 3 months |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
BS2 8HW
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 | 01/05/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/03/2018: Publication reference added.
