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ISRCTN
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ISRCTN75685248
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ClinicalTrials.gov identifier
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Public title
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A balanced randomised controlled trial to examine the effect of using the altered cast technique on patient satisfaction with and fit of new distal extension saddle partial dentures
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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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N0013146122
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Study hypothesis
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That there is no difference between the success of lower cobalt chromium distal extension saddle partial dentures made using or not using the altered cast technique.
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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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Patients attending Guy's Hospital for cobalt chromium distal extension saddle partial dentures.
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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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31/10/2005
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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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Not provided at time of registration
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Interventions
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Patients having lower cobalt chromium distal extension saddle partial dentures made at Guy's Hospital will be randomised into two groups. One group will have altered cast impressions made at the appropriate stage, the other group will not. Fit of the resulting dentures will be judged in the mouth using an accepted method. The amount of adjustment, if any, will be noted. Numbers of acceptable and unacceptable dentures will be recorded. Three months after the dentures are fitted patients will be sent a self-administered questionnaire to be completed to determine usage of the dentures.
Added July 2008: the trial was stopped due to lack of funding.
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Primary outcome measure(s)
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Fit of dentures, need for adjustment, acceptability, and 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
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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12/04/2011
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Date ISRCTN assigned
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30/09/2005
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