Condition category
Oral Health
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
20/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss I Kapetania

ORCID ID

Contact details

The Worsley Building
Leeds General Infirmary
Clarendon Way
Leeds
LS2 9LU
United Kingdom
+44 (0)113 243 2799

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436133177

Study information

Scientific title

Acronym

Study hypothesis

The 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

Not provided at time of registration

Study design

Randomised placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Dental materials

Intervention

Randomised controlled trial. Two types of glass devices (one with flouride, the other without) are ramdomly attached to the buccal side of maxillary molar.

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measures

Measurements of levels of fluoride, calcium and phosphorus in saliva and dental plaque

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2003

Overall trial end date

01/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy adults aged 18-65 years residing in Leeds

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2003

Recruitment end date

01/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Worsley Building
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

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

Funders

Funder type

Hospital/treatment centre

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes