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ISRCTN
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ISRCTN22203853
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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 usefulness of alginate and polyvinylsiloxane as impression materials for cobalt chromium 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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N0013146124
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Study hypothesis
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That there is no difference between the fit of cobalt chromium partial dentures made using irreversible hydrocolloid impressions and those made using polyvinylsiloxane impressions.
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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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100 patients attending Guy's Hospital for bounded 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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01/09/2004
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Anticipated end date
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31/08/2005
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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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100
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Interventions
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This is a randomised controlled trial, patients having cobalt chromium bonded saddle partial dentures made at Guy's Hospital will be randomised into two groups, comparing master impressions for partial dentures made using either irreversible hydrocolloid or polyvinylsiloxane impression material. Fit of the resulting cobalt chromium castings will be judged using an accepted method on master models and in the mouth, before and after adjustment. The amount of adjustment, if any, will be noted. Numbers of acceptable and unacceptable castings will be recorded.
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 denture castings, need for adjustment and acceptability.
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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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12/04/2011
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Date ISRCTN assigned
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30/09/2005
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