Contact information
Type
Scientific
Primary contact
Miss Nikki Atack
ORCID ID
Contact details
Department of Orthodontics
Taunton & Somerset Hospital
Musgrove Park
Taunton
TA1 5DA
United Kingdom
+44 (0)1823 342136
nicola.atack@tst.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0249180873
Study information
Scientific title
A randomised controlled trial comparing conventional, active and passive self-ligating orthodontic bracket systems
Acronym
Study hypothesis
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
Somerset Research Ethics Committee (UK), 08/03/2006, REC ref: 06/Q2202/6
Study design
Double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Oral Health: Orthodontics
Intervention
1. Standard GAC Omni bracket
2. System R GAC Omni bracket
3. Damon bracket
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Before September 2008: time to alignment, chairside time.
Modified September 2008: overall treatment time and chairside time.
Secondary outcome measures
Added September 2008: time to initial alignment and time for space closure.
Overall trial start date
01/03/2006
Overall trial end date
01/04/2009
Reason abandoned
Eligibility
Participant inclusion criteria
100 children under 18 requiring routine upper and lower fixed appliances following extraction.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/03/2006
Recruitment end date
01/04/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Taunton & Somerset Hospital
Taunton
TA1 5DA
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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
Taunton and Somerset Research and Development Consortium (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
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24785921