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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison of Foam Swabs Versus Toothbrushes in Removing Dental Plaque From Orally Intubated Mechanically Ventilated Patients

Brief Summary: 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.

Detailed Summary:

Study Objective: The principle aim of this work is to determine whether foam swabs or toothbrushes offer the most effective method of removing dental plaque in orally intubated mechanically ventilated patients.

The secondary objective is to profile the microbiological flora in dental plaque, endotracheal tube and lung. In addition, collection of both plaque samples, used endotracheal tubes (ETTs) and non-directed bronchoalveolar lavage (NBL) will allow us to determine whether oral microorganisms contribute to biofilm formation within the ETT and potentially promote VAP. The findings of this study will not only enhance our knowledge on the organisms involved in promoting biofilms on ETT, but may also highlight potential management strategies to reduce their formation.

Study Population: Critically ill adult patients admitted to the intensive care unit at the University Hospital of Wales, Cardiff in whom mechanical ventilation has been initiated.

Recruitment: All patients satisfying inclusion and exclusion criteria, admitted to the adult ICU at the University Hospital of Wales from the start date of the study will be considered eligible for recruitment. Patients identified by the duty consultant will be notified to the research team. Consent will be obtained and in total 50 patients will be recruited.

Interventions: This is a split mouth design study whereby the intervention (cleaning with a foam swab or toothbrush) is performed on one side of the mouth. For example foam swab left side of mouth and toothbrush right side of mouth. Cleaning will be performed daily for a minimum of 24-hours or until extubation or up to seven days after recruitment, whichever is the shorter.

Non-dir
Sponsor: Cardiff and Vale University Health Board

Current Primary Outcome: 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


Original Primary Outcome: Modified Silness and Loe plaque and gingival index following cleaning of teeth [ Time Frame: Daily until day seven ]

Current Secondary Outcome: Quantitative comparisons of bacterial counts following the two cleaning methods [ Time Frame: Daily until day seven ]

Original Secondary Outcome: Same as current

Information By: Cardiff and Vale University Health Board

Dates:
Date Received: June 14, 2010
Date Started: June 2010
Date Completion: June 2011
Last Updated: June 30, 2010
Last Verified: March 2010