| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN75685248 |
| Date ISRCTN assigned | 30/09/2005 |
| Local reference number(s) | N0013146122 |
| Public title | 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 |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Oral Health: |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients attending Guy's Hospital for cobalt chromium distal extension saddle partial dentures. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 01/03/2004 |
| Anticipated end date | 31/10/2005 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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.
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| Primary outcome measure(s) | Fit of dentures, need for adjustment, acceptability, and patient wear of dentures. |
| 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 | ISRCTN75685248 |
| Date last extracted from ISRCTN register | 17/04/2008 |
