A randomised controlled trial comparing conventional, active and passive self-ligating orthodontic bracket systems

ISRCTN	ISRCTN51381850
DOI	https://doi.org/10.1186/ISRCTN51381850
Secondary identifying numbers	N0249180873

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Miss Nikki Atack
Scientific

Department of Orthodontics
Taunton & Somerset Hospital
Musgrove Park
Taunton
TA1 5DA
United Kingdom

Phone	+44 (0)1823 342136
Email	nicola.atack@tst.nhs.uk

Study design	Double-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A randomised controlled trial comparing conventional, active and passive self-ligating orthodontic bracket systems
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(s)	Somerset Research Ethics Committee (UK), 08/03/2006, REC ref: 06/Q2202/6
Condition	Oral Health: Orthodontics
Intervention	1. Standard GAC Omni bracket 2. System R GAC Omni bracket 3. Damon bracket
Intervention type	Other
Primary outcome measure	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 study start date	01/03/2006
Overall study end date	01/04/2009

Participant type(s)	Patient
Age group	Child
Upper age limit	18 Years
Sex	Both
Target number of participants	100
Participant inclusion criteria	100 children under 18 requiring routine upper and lower fixed appliances following extraction.
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

Taunton & Somerset Hospital

Taunton
TA1 5DA
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Taunton and Somerset Research and Development Consortium (UK)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2014		Yes	No

13/04/2018: Publication reference added.
31/03/2016: No publications found, verifying study status with principal investigator