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

ISRCTN ISRCTN75685248
DOI https://doi.org/10.1186/ISRCTN75685248
Secondary identifying numbers N0013146122
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
12/04/2011
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Michael Fenlon
Scientific

Dental Prosthetics
Room 304, 25th Floor, Guy's Tower
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom

Phone +44 (0)20 7188 7479
Email michael.fenlon@kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study hypothesisThat 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.
Ethics approval(s)Not provided at time of registration
ConditionOral Health
InterventionPatients 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.
Intervention typeOther
Primary outcome measureFit of dentures, need for adjustment, acceptability, and patient wear of dentures.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/03/2004
Overall study end date31/10/2005
Reason abandoned (if study stopped)Lack of funding

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Participant inclusion criteriaPatients attending Guy's Hospital for cobalt chromium distal extension saddle partial dentures.
Participant exclusion criteriaNot provided at time of registration
Recruitment start date01/03/2004
Recruitment end date31/10/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Dental Prosthetics
London
SE1 9RT
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Guy's and St. Thomas' NHS Foundation Trust

No information available

Own account

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan