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The effect of a fluoride releasing, non-primer step required, no mix composite: A clinical trial
ISRCTN ISRCTN05340070
ClinicalTrials.gov identifier
Public title The effect of a fluoride releasing, non-primer step required, no mix composite: A clinical trial
Scientific title
Acronym N/A
Serial number at source N0263139746
Study hypothesis To determine the failure rate and survival time of orthodontic bands cemented with a fluoride releasing, non-primer step required, no mix composite compared with a conventional no-mix composite and if there is a difference in demineralisation.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Oral Health: Orthodontics
Participants - inclusion criteria Not provided at time of registration
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 17/03/2004
Anticipated end date 01/07/2007
Status of trial Completed
Patient information material
Target number of participants 50 patients from Orthodontics
Interventions 1. Fluoride releasing, non-primer step required, no mix composite
2. Conventional no mix composite
Primary outcome measure(s) The site and time to bond failure to be recorded for each bracket that fails over a six month period (in the first instance) and then up to the completion of treatment.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding University College London Hospitals NHS Trust (UK)
Trial website
Publications
Contact name Miss  Samantha  Hodge
  Address Department of Orthodontics
Eastman Dental Hospital
256 Gray's Inn Road
  City/town London
  Zip/Postcode WC1X 8LD
  Country United Kingdom
  Tel +44 (0)20 7915 1000
  Email
Sponsor Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
  Address The Department of Health,
Richmond House,
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2004
Last edited 17/03/2011
Date ISRCTN assigned 30/09/2004
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