ISRCTN ISRCTN21526533
DOI https://doi.org/10.1186/ISRCTN21526533
Protocol serial number N0263177828
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders University College London Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
17/08/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr IG Needleman
Scientific

International Centre for Evidence-Based Oral Health
Department of Periodontology
UCL Eastman Dental Institute
256 Grays Inn Road
London
WC1X 8LD
United Kingdom

Phone +44 (0)20 7915 2340
Email I.Needleman@eastman.ucl.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleDental plaque control to reduce ventilator-associated pneumonia
Study objectivesDoes a sponge toothette or electric toothbrush differentially affect the oral flora of intubated intensive care patients?
Ethics approval(s)Added 15 May 2008: Joint UCL/UCLH Committee on the Ethics of Human Research, 05/Q0502/135
Health condition(s) or problem(s) studiedOral Health
Intervention1. Sponge toothette
2. Electric toothbrush
Intervention typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date01/06/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration100
Key inclusion criteriaAdded 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
Key exclusion criteriaAdded 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
Date of first enrolment01/06/2006
Date of final enrolment01/06/2009

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2011 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

17/08/2018: Publication reference added