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 |
| Protocol serial number | N0436189315 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Johnson & Johnson Wound Management (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
To determine which impression procedure produces the most comfortable lower denture |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Leeds Dental Institute
Leeds
LS2 9LU
United Kingdom
LS2 9LU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
