Self-ligating brackets and elastomeric rings - a comparison of orthodontic ligation techniques on patient oral hygiene and microbial colonisation
| ISRCTN | ISRCTN56613406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56613406 |
| Secondary identifying numbers | N0236169540 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 18/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Tasnim Hassan
Scientific
Scientific
Orthodontic Department
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
| Phone | +44 (0)20 8672 1255/1257 |
|---|---|
| tasnim1000@yahoo.co.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 |
| Scientific title | Self-ligating brackets and elastomeric rings - a comparison of orthodontic ligation techniques on patient oral hygiene and microbial colonisation |
| Study objectives | The aim of this research is to investigate and compare two methods of orthodontic bracket ligation (typing of the arch wire to the orthodontic brackets) and their effects on patient oral hygiene and microbial colonization. The two fixed appliances under investigation will be 3M conventional MBT Siamese brackets and £M self-ligating 'Smart Click' brackets. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health |
| Intervention | Following consent, patients undergoing routine orthodontic treatment will be randomly allocated to one of two groups: 1. Treatment with conventional pre-adjusted edgewise brackets secured by elastic ties (victory series) 2. Treatment with smart click pre-adjusted self-ligating brackets which do not require tying Both systems would be of the same prescription and the same archwires would be used. All patients will receive instruction in oral hygiene from a hygienist within the department before the start of treatment. Following extraction of the teeth, upper and lower fixed appliances will be placed with an initial aligning archwire of 014 Nickel Titanium. Patients will be reviewed every 4 weeks for treatment. The oral hygiene will be assessed and plaque and saliva samples will be taken (using non-invasive methods) before placement of the appliance, and then 3, 6 and 12 months following the placement of the appliances. At 6 months the rate of oral clearance of food will also be measured. All methods of assessment are non-invasive. The oral hygiene will be assessed by: 1. Measuring the amount of dental plaque present on the outside surface of each tooth 2. Assessing the presence or absence of gingival (gum) swelling/inflammation and bleeding The oral clearance of food will be measured once by asking the patient to eat a digestive biscuit for 1 minute, following which time the patient will be asked to produce a sample of saliva by spitting into a container. This will be collected by a qualified dentist. All samples will then be analysed in the microbiology department at Guy's Hospital. |
| Intervention type | Other |
| Primary outcome measure | 1. Patient oral hygiene as measured by plaque, and gingival indices 2. Microbiological profile of plaque bacteria 3. Salivary sugar levels to reflect the oral clearance of foods |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2005 |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients recruited from the treatment waiting lists who present with a crowded dentition that requires the extraction of premolar teeth and fixed appliance therapy |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 31/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Orthodontic Department
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
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
St George's Healthcare NHS Trust (UK)
No information available
NHS R&D Support Funding (UK)
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 |
Editorial Notes
18/05/2017: No publications found in PubMed, verifying study status with principal investigator.
