|
ISRCTN
|
ISRCTN65954262
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Randomized controlled clinical trial of impression techniques designed to alleviate the pain of lower dentures in patients with severely resorbed mandibles
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0436189315
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Oral Health: Resorbed mandibles
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/09/2006
|
|
Anticipated end date
|
01/03/2009
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
Comparison of impression techniques
|
|
Primary outcome measure(s)
|
To determine which impression procedure produces the most comfortable lower denture
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Johnson & Johnson Wound Management (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
AJ
Blance
|
|
Address
|
Leeds Dental Institute
University of Leeds
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS2 9LU
|
|
Country
|
United Kingdom
|
|
Tel
|
+44
|
|
Fax
|
+44
|
|
Email
|
a.j.blance@leeds.ac.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
28/09/2007
|
|
Last edited
|
22/05/2008
|
|
Date ISRCTN assigned
|
28/09/2007
|
