Contact information
Type
Scientific
Primary contact
Mrs G Kotru
ORCID ID
Contact details
Department of Child Dental Health
Leeds Dental Institute
The Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom
+44 (0)113 343 6177
r&d@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436146538
Study information
Scientific title
The effect of the intra oral slow release fluoride device in remineralisation of enamel and dentine in situ.
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Oral Health
Intervention
Randomised controlled trial. Random allocation to various flow rates
Intervention type
Device
Phase
Not Specified
Drug names
Primary outcome measures
A future device to prevent caries
Secondary outcome measures
Not provided at time of registration
Overall trial start date
28/04/2004
Overall trial end date
01/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Population from Yorkshire region. Total Target Recruitment: 25.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25
Participant 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.
Recruitment start date
28/04/2004
Recruitment end date
01/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Child Dental Health
Leeds
LS2 9LU
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary