Comparison of Swabs and Toothbrushes in Cleaning the Teeth of Mechanically Ventilated Patients - Full Text View

Purpose

Cleaning the mouth is difficult in critically ill patients who require support from a breathing machine (ventilator). This is because the plastic (endotracheal) tube which is a necessary interface between patient and ventilator impedes cleaning. New evidence suggests that poor oral health may be linked to ventilator associated pneumonia. Throughout the world both toothbrushes and foam swabs are used to clean the teeth and remove dental plaque, however it is unknown if one method is more effective than the other. The purpose of this study is to establish which (if any) method is most effective at removing plaque in this population of patients.

Condition	Intervention
Dental Plaque Gingivitis	Procedure: Cleaning of teeth with a toothbrush Procedure: Cleaning of teeth with a foam swab


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of Foam Swabs Versus Toothbrushes in Removing Dental Plaque From Orally Intubated Mechanically Ventilated Patients

Further study details as provided by Cardiff and Vale University Health Board:

Primary Outcome Measures:

Modified Silness and Loe plaque and gingival index following cleaning of teeth [ Time Frame: Daily until day seven ] [ Designated as safety issue: No ]
The Silness and Loe plaque and gingival index scores plaque and gum disease as 0,1,2, or 3 for each tooth. The index is derived by adding scores and dividing by the number of teeth examined (maximum score 3, minimum 0). The index will be compared between teeth cleaned with a toothbrush versus those cleaned with a swab

Secondary Outcome Measures:

Quantitative comparisons of bacterial counts following the two cleaning methods [ Time Frame: Daily until day seven ] [ Designated as safety issue: No ]


Estimated Enrollment:	50
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cleaning teeth with toothbrush Following randomisation one side of the mouth (split mouth study) will be assigned to cleaning teeth with a toothbrush	Procedure: Cleaning of teeth with a toothbrush This is a split mouth study where patients will have one side of their mouth randomised for teeth cleaning with a toothbrush. Cleaning will be twice daily from recruitment until day seven.
Experimental: Cleaning teeth with foam swab Following randomisation one side of the mouth (split mouth study) will be assigned to cleaning teeth with a faom swab	Procedure: Cleaning of teeth with a foam swab This is a split mouth study where patients will have one side of their mouth randomised for teeth cleaning with a foam swab. Cleaning will be twice daily from recruitment until day seven.

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Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged >18 years
Patients mechanically ventilated with an oral endotracheal tube ->20 teeth with symmetric distribution

Exclusion Criteria:

Absence of an oral endotracheal tube
Age <18 years
<20 teeth or asymmetric distribution
Expected to be intubated less than 24-hours from recruitment
Thrombocytopaenia (platelet count <30)
Uncontrolled coagulopathy
Suffering from facial or oral trauma

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01154257

Locations


United Kingdom
Adult Critical Care University Hospital of Wales
Cardiff, South Glamorgan, United Kingdom, CF14 4XW

Sponsors and Collaborators

Cardiff and Vale University Health Board

Investigators


Principal Investigator:	Matt P Wise, DPhil	University Hospital of Wales Cardiff & Vale University Health Board

More Information

No publications provided


Responsible Party:	Matt P Wise, University Hospital of Wales, Cardiff and Vale University Health Board
ClinicalTrials.gov Identifier:	NCT01154257 History of Changes
Other Study ID Numbers:	09/MRE09/44
Study First Received:	June 14, 2010
Last Updated:	June 30, 2010
Health Authority:	United Kingdom: National Health Service

Keywords provided by Cardiff and Vale University Health Board:


Dental plaque Gingivitis

Additional relevant MeSH terms:


Dental Plaque Dental Deposits Stomatognathic Diseases Tooth Diseases

ClinicalTrials.gov processed this record on February 27, 2015