Contact information
Type
Scientific
Primary contact
Miss Tasnim Hassan
ORCID ID
Contact details
Orthodontic Department
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
+44 (0)20 8672 1255/1257
tasnim1000@yahoo.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0236169540
Study information
Scientific title
Self-ligating brackets and elastomeric rings - a comparison of orthodontic ligation techniques on patient oral hygiene and microbial colonisation
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/08/2005
Overall trial end date
31/01/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2005
Recruitment end date
31/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Orthodontic Department
London
SW17 0QT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
St George's Healthcare NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary