Condition category
Oral Health
Date applied
30/09/2004
Date assigned
30/09/2004
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

Mr B Alshammari

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
r&d@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436130443

Study information

Scientific title

Effect of Topacal C-5 on Enamel Remineralisation in Situ

Acronym

Study hypothesis

The aim of this study is to study the effect of Topacal C-5 which is milk protein based and fluoride free and its role in enamel remineralisation

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

Treatment

Patient information sheet

Condition

Oral Health: Dental materials

Intervention

Randomised controlled trial: Topacal C-5 or distilled water

Intervention type

Other

Phase

Not Specified

Drug names

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

01/02/2003

Overall trial end date

31/10/2003

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

Not provided at time of registration

Recruitment start date

01/02/2003

Recruitment end date

31/10/2003

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

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

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