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 |
| Protocol serial number | N0436165571 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Paediatric Department
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 | 01/06/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
