A prospective randomized trial investigating lower incisor inclination and mandibular arch dimensional changes of two pre-adjusted edgewise orthodontic bracket systems in non-extraction cases
| ISRCTN | ISRCTN67900267 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67900267 |
| Secondary identifying numbers | N0205186777 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 11/10/2011
- 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
Prof Robert T Lee
Scientific
Scientific
Orthodontics
Dental Institute
New Road
Whitechapel
London
E1 1BB
United Kingdom
| Phone | +44 020 7377 7397 |
|---|---|
| r.t.lee@qmul.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | In the UK most orthodontic treatment is carried out using fixed appliances or 'braces'. The first phase of fixed appliance orthodontic treatment is concerned principally with tooth alignment. Conventional fixed orthodontic brackets are cemented onto the teeth and attached to an arch wire using elastic ligatures. The teeth are then aligned using forces generated by the arch wire itself. Recently a ligature-free bracket system has been introduced. It has been suggested that reduced friction associated with this system can provide considerable benefits to the patient, principally because the teeth align more rapidly. We propose to investigate the nature of alignment of two fixed orthodontic bracket systems: Smart-Clip self ligating and Ormco Synthesis conventional siamese. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health: Orthodontics |
| Intervention | Smart-Clip® ligature free brackets vs conventional pre-adjusted edgewise brackets (3M Unitek). |
| Intervention type | Other |
| Primary outcome measure | The ability of two fixed appliance orthodontic bracket systems to align crowded lower incisors. In particular lower incisor inclination and arch form changes will be compared. Null hypothesis: there is no difference in lower incisor inclination, and angulation, and lower arch dimensions using self-ligating and conventional pre-adjusted edgewise brackets. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 22/09/2006 |
| Completion date | 21/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Patients should be fit and well and not currently on any medication or suffering from any craniofacial syndrome. Medication could theoretically affect the connective tissues that remodel during orthodontic treatment 2. Children under 18 years 3. Lower incisor tooth crowding of up to 5mm as part of their malocclusion 4. A requirement for fixed orthodontic treatment on a non-extraction basis 5. More severely crowded dentitions often require the loss of premolar teeth to provide the necessary space for alignment of the dental arch |
| Key exclusion criteria | 1. A complete overbite. Complete overbite might be expected to reduce rates of tooth alignment due to bracket interferences. 2. No incisor teeth completely excluded from the dental arch |
| Date of first enrolment | 22/09/2006 |
| Date of final enrolment | 21/05/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Orthodontics
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, 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
Barts and The London NHS Trust (UK), 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 | 01/05/2009 | Yes | No | |
| Results article | results | 01/09/2009 | Yes | No |
