Condition category
Oral Health
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
04/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr AJ Blance

ORCID ID

Contact details

Leeds Dental Institute
University of Leeds
Leeds
LS2 9LU
United Kingdom
+44
a.j.blance@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436189315

Study information

Scientific title

Acronym

Study hypothesis

1. To provide 3 lower dentures for each research participant each one identical except for the manner in which the fitting surface has been contoured
2. To allow the research participant to assess each denture
3. To allow the research participant to choose the denture they find the most comfortable

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oral Health: Resorbed mandibles

Intervention

Comparison of impression techniques

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To determine which impression procedure produces the most comfortable lower denture

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2006

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients able to attend
2. Edentulous in the lower arch with the mental foramen apparent clinically or radiographically on the denture bearing area of the lower residual alveolar ridge

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2006

Recruitment end date

01/03/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds Dental Institute
Leeds
LS2 9LU
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
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

Industry

Funder name

Johnson & Johnson Wound Management (UK)

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20637826

Publication citations

  1. Results

    Hyde TP, Craddock HL, Blance A, Brunton PA, A cross-over Randomised Controlled Trial of selective pressure impressions for lower complete dentures., J Dent, 2010, 38, 11, 853-858, doi: 10.1016/j.jdent.2010.07.003.

Additional files

Editorial Notes