Condition category
Oral Health
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
22/07/2013
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 S Papanica

ORCID ID

Contact details

Department of Child Dental Health
Leeds Dental Institute
The Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom
+44 (0)113 233 6138

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes