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ISRCTN
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ISRCTN66185030
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ClinicalTrials.gov identifier
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Public title
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A prospective randomized trial investigating the alignment efficiency of two pre-adjusted edgewise orthodontic bracket systems
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013154732
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Oral Health
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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08/11/2004
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Anticipated end date
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30/11/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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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.
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Primary outcome measure(s)
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1. Speed of alignment of the lower labial segment
2. Self reported pain or discomfort and root resorption of lower central incisors
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust (UK)
Own account
NHS R&D Support Funding
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18339656
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Contact name
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Dr
Martyn
Cobourne
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Address
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Department of Orthodontics
F22 Guy's Tower
Guy's Hospital
St Thomas Street
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 4432
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Fax
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+44 (0)20 7188 4415
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Email
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martyn.cobourne@kcl.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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12/04/2011
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Date ISRCTN assigned
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30/09/2005
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