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
Protocol serial number	N0013146122
Sponsor	Department of Health
Funders	Guy's and St. Thomas' NHS Foundation Trust, Own account, NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Oral Health
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	Fit of dentures, need for adjustment, acceptability, and patient wear of dentures.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/10/2005
Reason abandoned (if study stopped)	Lack of funding

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Patients attending Guy's Hospital for cobalt chromium distal extension saddle partial dentures.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/03/2004
Date of final enrolment	31/10/2005

Dental Prosthetics

London
SE1 9RT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan