Comparison of Swabs and Toothbrushes in Cleaning the Teeth of Mechanically Ventilated Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2010 by Cardiff and Vale University Health Board.
Recruitment status was: Enrolling by invitation

Sponsor:

Information provided by:

Cardiff and Vale University Health Board

ClinicalTrials.gov Identifier:

NCT01154257

First received: June 14, 2010

Last updated: June 30, 2010

Last verified: March 2010

History of Changes

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 Intervention Model: Single Group Assignment Masking: None (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 ]
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 ]


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.

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Marino PJ, Hannigan A, Haywood S, Cole JM, Palmer N, Emanuel C, Kinsella T, Lewis MA, Wise MP, Williams DW. Comparison of foam swabs and toothbrushes as oral hygiene interventions in mechanically ventilated patients: a randomised split mouth study. BMJ Open Respir Res. 2016 Oct 14;3(1):e000150. eCollection 2016.


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

Keywords provided by Cardiff and Vale University Health Board:


Dental plaque Gingivitis

Additional relevant MeSH terms:


Gingivitis Dental Plaque Gingival Diseases Periodontal Diseases	Mouth Diseases Stomatognathic Diseases Dental Deposits Tooth Diseases

ClinicalTrials.gov processed this record on September 21, 2017

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