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
Secondary identifying numbers N0436146538
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

Department of Child Dental Health
Leeds Dental Institute
The Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom

Phone +44 (0)113 343 6177
Email r&d@leedsth.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Scientific titleThe effect of the intra oral slow release fluoride device in remineralisation of enamel and dentine in situ.
Study objectivesTo 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) studiedOral Health
InterventionRandomised controlled trial. Random allocation to various flow rates
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)
Primary outcome measureA future device to prevent caries
Secondary outcome measuresNot provided at time of registration
Overall study start date28/04/2004
Completion date01/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants25
Key inclusion criteriaPopulation from Yorkshire region. Total Target Recruitment: 25.
Key exclusion criteria1. 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 enrolment28/04/2004
Date of final enrolment01/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Child Dental Health
Leeds
LS2 9LU
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

24/05/2016: No publications found, study status unverified