Condition category
Oral Health
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Fenlon

ORCID ID

Contact details

Dental Prosthetics
Room 304
25th Floor
Guy's Tower
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 7479
michael.fenlon@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013146124

Study information

Scientific title

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Oral Health

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

alginate and polyvinylsiloxane

Primary outcome measures

Fit of denture castings, need for adjustment and acceptability.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2004

Overall trial end date

31/08/2005

Reason abandoned

Lack of funding

Eligibility

Participant inclusion criteria

100 patients attending Guy's Hospital for bounded saddle partial dentures.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2004

Recruitment end date

31/08/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dental Prosthetics
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Guy's and St. Thomas' NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own account

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes