A balanced randomised controlled trial to examine the usefulness of alginate and polyvinylsiloxane as impression materials for cobalt chromium partial dentures.
| ISRCTN | ISRCTN22203853 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22203853 |
| Secondary identifying numbers | N0013146124 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 12/04/2011
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | That there is no difference between the fit of cobalt chromium partial dentures made using irreversible hydrocolloid impressions and those made using polyvinylsiloxane impressions. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health |
| Intervention | This is a randomised controlled trial, patients having cobalt chromium bonded saddle partial dentures made at Guy's Hospital will be randomised into two groups, comparing master impressions for partial dentures made using either irreversible hydrocolloid or polyvinylsiloxane impression material. Fit of the resulting cobalt chromium castings will be judged using an accepted method on master models and in the mouth, before and after adjustment. The amount of adjustment, if any, will be noted. Numbers of acceptable and unacceptable castings will be recorded. Added July 2008: the trial was stopped due to lack of funding. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | alginate and polyvinylsiloxane |
| Primary outcome measure | Fit of denture castings, need for adjustment and acceptability. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2004 |
| Completion date | 31/08/2005 |
| Reason abandoned (if study stopped) | Lack of funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 |
| Key inclusion criteria | 100 patients attending Guy's Hospital for bounded saddle partial dentures. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/08/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dental Prosthetics
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Department of Health
Government
Government
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
Government
Guy's and St. Thomas' NHS Foundation Trust (UK)
No information available
Own account
No information available
NHS R&D Support Funding
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 |
