The effect of the intra oral slow release fluoride device in remineralisation of enamel and dentine in situ.
| ISRCTN | ISRCTN21720818 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21720818 |
| Protocol serial number | N0436146538 |
| Sponsor | Department of Health |
| Funders | Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 24/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Mrs G Kotru
Scientific
Scientific
Department of Child Dental Health
Leeds Dental Institute
The Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom
| Phone | +44 (0)113 343 6177 |
|---|---|
| r&d@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effect of the intra oral slow release fluoride device in remineralisation of enamel and dentine in situ. |
| Study objectives | To evaluate the remineralisation of enamel and dentine using the slow release fluoride glass device. The remineralisation will be evaluated using micro hardness and transverse microradiography |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health |
| Intervention | Randomised controlled trial. Random allocation to various flow rates |
| Intervention type | Device |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
A future device to prevent caries |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 25 |
| Key inclusion criteria | Population from Yorkshire region. Total Target Recruitment: 25. |
| Key exclusion criteria | 1. Aged less than 18 years old 2. DMFS below 12 3. Less than 18 natural teeth 4. Salivary flow rate of less than 0,25ml/min 5. If plaque pH does not fall by a one unit after 5min or 10 min of sucrose rinse. |
| Date of first enrolment | 28/04/2004 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Child Dental Health
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 |
Editorial Notes
24/05/2016: No publications found, study status unverified
