Condition category
Oral Health
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
29/03/2012
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

Mr Hani Abudiak

ORCID ID

Contact details

Paediatric Department
The Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom
+44 0113 343 6140
Den1had@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436165571

Study information

Scientific title

Acronym

Study hypothesis

Determine the effect of the FSSRD on fluoride, calcium and phosphorus levels in undisturbed plaque biofilms in vivo for both adults and children.

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

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Oral Health

Intervention

Not provided at time of registration

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measures

Increase concentration of Fluoride in dental plaque and saliva. Fluoride has anticariogenic effect. The device will help protect the teeth specially of high caries susceptible groups (medically compromised, patients with special needs etc).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2005

Overall trial end date

30/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Population from Yorkshire

Participant type

Patient

Age group

Not Specified

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

01/02/2005

Recruitment end date

30/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Paediatric Department
Leeds
LS2 9LU
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21640062

Publication citations

  1. Results

    Abudiak H, Robinson C, Duggal MS, Strafford S, Toumba KJ, The effect of fluoride slow-releasing devices on fluoride in plaque biofilms and saliva: a randomised controlled trial., Eur Arch Paediatr Dent, 2011, 12, 3, 163-166.

Additional files

Editorial Notes