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ISRCTN
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ISRCTN36747800
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ClinicalTrials.gov identifier
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Public title
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A pilot study to examine factors associated with excessive gagging in denture patients. A randomised controlled trial
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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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N0013146125
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Study hypothesis
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That there is no difference between the success of and impact on oral health of patients of lower cobalt chromium distal extension saddle partial dentures and single cantilever distal extension resin bonded bridges.
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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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Oral Health
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Participants - inclusion criteria
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100 patients attending Guy's Hospital for prostheses for edentulous distal extension saddle areas.
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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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01/03/2004
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Anticipated end date
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30/09/2007
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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100
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Interventions
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Patients suitable for cobalt chromium lower distal extension saddle partial dentures made at Guy's Hospital will be randomised into two groups:
1. One group will have the dentures
2. The other will have one or two distal cantilever minimum preparation resin bonded bridges
The success, ongoing problems, maintenance requirements and impact on oral health of the different restorations will be monitored over 5 years.
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Primary outcome measure(s)
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1. Fit of dentures
2. Need for adjustment,
3. Acceptability
4. Patient wear of dentures
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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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Contact name
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Dr
Michael
Fenlon
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Address
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Dental Prosthetics
Room 304, 25th Floor, 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 7479
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Fax
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+44
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Email
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michael.fenlon@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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20/10/2011
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Date ISRCTN assigned
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30/09/2005
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