Condition category
Oral Health
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
15/05/2008
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

Dr IG Needleman

ORCID ID

Contact details

International Centre for Evidence-Based Oral Health
Department of Periodontology
UCL Eastman Dental Institute
256 Grays Inn Road
London
WC1X 8LD
United Kingdom
+44 (0)20 7915 2340
I.Needleman@eastman.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263177828

Study information

Scientific title

Acronym

Study hypothesis

Does a sponge toothette or electric toothbrush differentially affect the oral flora of intubated intensive care patients?

Ethics approval

Added 15 May 2008: Joint UCL/UCLH Committee on the Ethics of Human Research, 05/Q0502/135

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

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

Condition

Oral Health

Intervention

1. Sponge toothette
2. Electric toothbrush

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Description of extent of dental plaque and bacterial species present in dental plaque of intubated intensive care patients.

Secondary outcome measures

Added 15 May 2008:
1. Incidence of ventilator associated pneumonia
2. Mortality

Overall trial start date

01/06/2006

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Added 15 May 2008:
Emergency admission to neurosurgical ICU who have:
1. Been in hospital for less than 24 hours prior to their admission to ICU
2. Expected to survive for more than 48 hours
3. Expected to be intubated for at least 48 hours

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100 patients from Neurosurgery/NSITU

Participant exclusion criteria

Added 15 May 2008:
1. Edentulous patients
2. Those with a known adverse reaction to chlorhexidine
3. Patients will also be barred who have had a recent chest infection

Recruitment start date

01/06/2006

Recruitment end date

01/06/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

International Centre for Evidence-Based Oral Health
London
WC1X 8LD
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

University College London Hospitals NHS Foundation 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

2007 conference abstract on protocol: http://iadr.confex.com/iadr/bsdr07/techprogram/abstract_94756.htm

Publication citations

Additional files

Editorial Notes