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ISRCTN
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ISRCTN91891418
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ClinicalTrials.gov identifier
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Public title
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Evaluation of cutting balloons for treatment of salivary duct strictures
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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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N0013145948
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Study hypothesis
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Are cutting balloons more effective than conventional angioplasty balloons for treating salivary duct strictures?
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Lay summary
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Not provided at time of registration
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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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Salivary duct stenosis
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Participants - inclusion criteria
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All patients requiring treatment for salivary obstruction due to stenosis.
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Participants - exclusion criteria
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1. Any patient suffering from an acute or chronic systemic illness that renders them unsuitable for elective outpatient dental treatment under local anaesthesia
2. Pregnant women
3. Patients exhibiting signs or symptoms of acute infection of the salivary gland under examination
4. Patients with an allergy to iodine (as in radiographic contrast agents) or local anaesthetic agents
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Anticipated start date
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01/06/2003
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Anticipated end date
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01/12/2005
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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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25
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Interventions
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A randomised controlled trial comparing the use of conventional balloons used for the treatment of salivary stenosis versus cutting balloons.
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Primary outcome measure(s)
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Clinical evaluation and radiological (sialogram) follow up
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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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1. Guy's and St. Thomas' NHS Foundation Trust (UK)
2. Own account
3. NHS R&D Support Funding (UK)
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Trial website
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Publications
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Contact name
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Mrs
Jackie
Brown
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Address
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Dental Radiology
F23 Guys Tower
Guys 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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SE21 9RT
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Country
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United Kingdom
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Email
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jackie.brown@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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14/11/2011
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Date ISRCTN assigned
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30/09/2005
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