A pilot study to examine factors associated with excessive gagging in denture patients. A randomised controlled trial
| ISRCTN | ISRCTN36747800 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36747800 |
| Protocol serial number | N0013146125 |
| Sponsor | Department of Health |
| Funders | Guy's and St. Thomas' NHS Foundation Trust (UK), Own account - NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 20/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Fenlon
Scientific
Scientific
Dental Prosthetics
Room 304, 25th Floor, Guy's Tower
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7188 7479 |
|---|---|
| michael.fenlon@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | That there is no difference between the success of and impact on oral health of patients of lower cobalt chromium distal extension saddle partial dentures and single cantilever distal extension resin bonded bridges. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health |
| Intervention | Patients suitable for cobalt chromium lower distal extension saddle partial dentures made at Guy's Hospital will be randomised into two groups: 1. One group will have the dentures 2. The other will have one or two distal cantilever minimum preparation resin bonded bridges The success, ongoing problems, maintenance requirements and impact on oral health of the different restorations will be monitored over 5 years. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Fit of dentures |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2007 |
| Reason abandoned (if study stopped) | Lack of funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 patients attending Guy's Hospital for prostheses for edentulous distal extension saddle areas. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Dental Prosthetics
London
SE1 9RT
United Kingdom
SE1 9RT
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 |
