Effect of fluoride sustained slow release devices on fluoride, phosphate and calcium levels in plaque biofilms
| ISRCTN | ISRCTN37527364 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37527364 |
| Secondary identifying numbers | N0436165571 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 29/03/2012
- 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 Hani Abudiak
Scientific
Scientific
Paediatric Department
The Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom
| Phone | +44 0113 343 6140 |
|---|---|
| Den1had@leeds.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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Determine the effect of the FSSRD on fluoride, calcium and phosphorus levels in undisturbed plaque biofilms in vivo for both adults and children. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health |
| Intervention | Not provided at time of registration |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Increase concentration of Fluoride in dental plaque and saliva. Fluoride has anticariogenic effect. The device will help protect the teeth specially of high caries susceptible groups (medically compromised, patients with special needs etc). |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2005 |
| Completion date | 30/12/2008 |
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 | Population from Yorkshire |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 30/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Paediatric Department
Leeds
LS2 9LU
United Kingdom
LS2 9LU
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 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
Government
Leeds Teaching Hospitals NHS Trust (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2011 | Yes | No |
