Condition category
Oral Health
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
28/02/2014
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 L Matthaiou

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 6177

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436118019

Study information

Scientific title

Acronym

Study hypothesis

To measure the effect on enamel microhardness of three test foods as compared to a 10% sucrose solution and a 10% sorbitol solution.

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: Cariology

Intervention

Randomised controlled trial. Random allocation to:
1. Test food one
2. Test food two
3. Test food three
4. 10% sucrose solution
5. 10% sorbitol solution

Intervention type

Drug

Phase

Not Specified

Drug names

10% sucrose solution, 10% sorbitol solution

Primary outcome measures

Demineralisation of enamel slabs (assessed by changes in microhardness)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

24/03/2003

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Eight fit and healthy adults recruited from staff of the Leeds Dental Institute, Leeds NHS Trust, Leeds University, students (other than undergraduate dental students) of Leeds University.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

24/03/2003

Recruitment end date

30/06/2003

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 (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

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