Condition category
Oral Health
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
24/05/2016
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

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

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

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

Publication citations

Additional files

Editorial Notes

24/05/2016: No publications found, study status unverified