A prospective randomized trial investigating the alignment efficiency of two pre-adjusted edgewise orthodontic bracket systems
| ISRCTN | ISRCTN66185030 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66185030 |
| Secondary identifying numbers | N0013154732 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/04/2011
- 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
Dr Martyn Cobourne
Scientific
Scientific
Department of Orthodontics
F22 Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7188 4432 |
|---|---|
| martyn.cobourne@kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Recently a ligature free orthodontic 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 alignment rate of two fixed orthodontic vracked systems; Ormco Damon-2 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 |
| Intervention | A Prospective Randomised Controlled Clinical Trial comparing Ormco Damon 2 ligature free bracket system and Ormco conventional pre-adjusted edgewise bracket system. The patients will be given a "pain diary " to complete and they will be reviewed six weekly. Patients will be randomly allocated to one of the two groups. |
| Intervention type | Other |
| Primary outcome measure | 1. Speed of alignment of the lower labial segment 2. Self reported pain or discomfort and root resorption of lower central incisors |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 08/11/2004 |
| Completion date | 30/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Not Specified |
| Target number of participants | 60 |
| Key inclusion criteria | Children under the age of 16, fit and well and not taking any medication; who present with a crowded dentition that require extraction of first pre-molars and fixed appliance therapy. 30 patients at Guy's and 30 at Canterbury. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 08/11/2004 |
| Date of final enrolment | 30/11/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Orthodontics
London
SE1 9RT
United Kingdom
SE1 9RT
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
Guy's and St. Thomas' NHS Foundation Trust (UK)
No information available
Own account
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 | 01/06/2008 | Yes | No |
