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
Secondary identifying numbers N0436133177
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

The Worsley Building
Leeds General Infirmary
Clarendon Way
Leeds
LS2 9LU
United Kingdom

Phone +44 (0)113 243 2799
Email abc@email.com

Study information

Study designRandomised placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleEffect of Fluoride Slow-release Devices on salivary and plaque levels of fluoride, phosphorus and calcium
Study objectivesThe 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) studiedDental materials
InterventionRandomised controlled trial. Two types of glass devices (one with flouride, the other without) are ramdomly attached to the buccal side of maxillary molar.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)
Primary outcome measureMeasurements of levels of fluoride, calcium and phosphorus in saliva and dental plaque
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2003
Completion date01/07/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaHealthy adults aged 18-65 years residing in Leeds
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/09/2003
Date of final enrolment01/07/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Worsley Building
Leeds
LS2 9LU
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Leeds Teaching Hospitals NHS Trust (UK)

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

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.