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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN31051582 |
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Date of registration:
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29/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of orthodontic and conventional wire IMF in the open and closed management of mandibular fractures: a two centre randomised trial
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Scientific title:
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Date of first enrolment:
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01/06/2004 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN31051582 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Geraldine
Brown |
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Address:
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SSR Orthodontics
Whipps Cross University Hospital Trust
Whipps Cross Road
E11 1NR
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 150 patients 75 from this site. Included are all patients with a mandibular lower jaw fracture, over 16, no pre-existing dental disease, attending Whipps Cross NHS or Barts and the London NHS Trust.
Exclusion criteria: Under 16, pre-existing dental disease, multiple facial fractures, upper jaw fractures, alveolar fractures.
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Injury, Occupational Diseases, Poisoning: Mandibular fractures
Injury, Occupational Diseases, Poisoning
Mandibular fractures
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Intervention(s)
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Patients randomised into 2 groups: open or closed management of fracture using two different type of fixings, patient satisfaction questionnaire/VAS pain scores.
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Primary Outcome(s)
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To evaluate the two forms of treatment for cost benefit to the NHS.
Outcome measures: theatre time, length of stay, amount of follow up, patient satisfaction and pain experienced.
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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N0080141034
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Source(s) of Monetary Support
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Whipps Cross University Hospital NHS Trust (UK), NHS R&D Support Funding
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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