A randomised controlled trial comparing conventional, active and passive self-ligating orthodontic bracket systems
| ISRCTN | ISRCTN51381850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51381850 |
| Protocol serial number | N0249180873 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Taunton and Somerset Research and Development Consortium (UK) |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 13/04/2018
- 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
Miss Nikki Atack
Scientific
Scientific
Department of Orthodontics
Taunton & Somerset Hospital
Musgrove Park
Taunton
TA1 5DA
United Kingdom
| Phone | +44 (0)1823 342136 |
|---|---|
| nicola.atack@tst.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial comparing conventional, active and passive self-ligating orthodontic bracket systems |
| Study objectives | Do any of three routinely used brackets show superiority in terms of faster overall treatment time for patient and chairside time for clinicians? |
| Ethics approval(s) | Somerset Research Ethics Committee (UK), 08/03/2006, REC ref: 06/Q2202/6 |
| Health condition(s) or problem(s) studied | Oral Health: Orthodontics |
| Intervention | 1. Standard GAC Omni bracket 2. System R GAC Omni bracket 3. Damon bracket |
| Intervention type | Other |
| Primary outcome measure(s) |
Before September 2008: time to alignment, chairside time. |
| Key secondary outcome measure(s) |
Added September 2008: time to initial alignment and time for space closure. |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 children under 18 requiring routine upper and lower fixed appliances following extraction. |
| Key exclusion criteria | 1. Subjects with learning difficulties 2. Subjects who do not understand English 3. Subjects with incomplete labial segments, i.e. incisors or canines missing |
| Date of first enrolment | 01/03/2006 |
| Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Taunton & Somerset Hospital
Taunton
TA1 5DA
United Kingdom
TA1 5DA
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
13/04/2018: Publication reference added.
31/03/2016: No publications found, verifying study status with principal investigator
