Randomized controlled clinical trial of impression techniques designed to alleviate the pain of lower dentures in patients with severely resorbed mandibles
| ISRCTN | ISRCTN65954262 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65954262 |
| Secondary identifying numbers | N0436189315 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 04/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr AJ Blance
Scientific
Scientific
Leeds Dental Institute
University of Leeds
Leeds
LS2 9LU
United Kingdom
| Phone | +44 |
|---|---|
| a.j.blance@leeds.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health: Resorbed mandibles |
| Intervention | Comparison of impression techniques |
| Intervention type | Other |
| Primary outcome measure | To determine which impression procedure produces the most comfortable lower denture |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2006 |
| Completion date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/03/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leeds Dental Institute
Leeds
LS2 9LU
United Kingdom
LS2 9LU
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Industry
Johnson & Johnson Wound Management (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2010 | Yes | No |
