Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436130292
Study information
Scientific title
Acronym
Study hypothesis
The aim of this study is to study the effect of fluoride slow-release devices on enamel remineralisation under cariogenic challenge using an in situ model.
Ethics approval
No ethics information provided at time of registration.
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Oral Health: Cariology
Intervention
1. Device a
2. Device b
Intervention type
Drug
Phase
Not Specified
Drug names
Fluoride slow-release devices
Primary outcome measure
Remineralisation of enamel slabs as determined using transverse microradiography and microhardness testing.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2003
Overall trial end date
02/04/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy adults aged 16-65 years residing in Leeds.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2003
Recruitment end date
02/04/2004
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
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
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
Basic results (scientific)
Publication list