Effect of Fluoride Slow-release Devices on salivary and plaque levels of fluoride, phosphorus and calcium
| ISRCTN | ISRCTN16427142 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16427142 |
| Protocol serial number | N0436133177 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 26/02/2020
- 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
Miss I Kapetania
Scientific
Scientific
The Worsley Building
Leeds General Infirmary
Clarendon Way
Leeds
LS2 9LU
United Kingdom
| Phone | +44 (0)113 243 2799 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effect of Fluoride Slow-release Devices on salivary and plaque levels of fluoride, phosphorus and calcium |
| Study objectives | The aim of our study is to evaluate the levels of fluoride, calcium and phosphorus in saliva and in dental plaque from the release of fluoride slow-release devices. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Dental materials |
| Intervention | Randomised controlled trial. Two types of glass devices (one with flouride, the other without) are ramdomly attached to the buccal side of maxillary molar. |
| Intervention type | Device |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Measurements of levels of fluoride, calcium and phosphorus in saliva and dental plaque |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Key inclusion criteria | Healthy adults aged 18-65 years residing in Leeds |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/07/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Worsley Building
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? |
|---|---|---|---|---|---|
| Thesis results | doctoral thesis | No | No |
Editorial Notes
26/02/2020: Publication reference added.
