| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN22203853 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0013146124 |
| Public title | A balanced randomised controlled trial to examine the usefulness of alginate and polyvinylsiloxane as impression materials for cobalt chromium partial dentures. |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Oral Health: |
| Study hypothesis | That there is no difference between the fit of cobalt chromium partial dentures made using irreversible hydrocolloid impressions and those made using polyvinylsiloxane impressions. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 100 patients attending Guy's Hospital for bounded saddle partial dentures. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 01/09/2004 |
| Anticipated end date | 31/08/2005 |
| Status of trial | Completed |
| Target number of participants | 100 |
| Interventions | 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. |
| Primary outcome measure(s) | Fit of denture castings, need for adjustment and acceptability. |
| Secondary outcome measure(s) | See Primary outcome measures |
| Sources of funding | Guy's and St. Thomas' NHS Foundation Trust
Own account
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Michael Fenlon |
| Contact details | Dental Prosthetics
Room 304, 25th Floor, Guy's Tower
Guy's Hospital
St Thomas' Street
London
United Kingdom
SE1 9RT |
| Contact telephone | +44 (0)20 7188 7479 |
| Contact fax | +44 |
| Contact email | michael.fenlon@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN22203853 |
| Date last extracted from ISRCTN register | 17/04/2008 |
