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

This study is enrolling participants by invitation only.
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
  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.

  Show Detailed Description

  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
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

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

ClinicalTrials.gov processed this record on August 19, 2014