Despite its prominent position in bedside care, there is little evidence to judge the benefits or associated risks of nurse-administered tooth brushing for mechanically ventilated adults, and the optimal frequency of tooth brushing in the critically il has never been experimentally determined. This project will complete the examination of oral care interventions in mechanically ventilated adults with a randomized clinical trial of tooth brushing frequency (once, twice, or three times daily) focused on conclusively defining the benefit and risk of varied frequencies, and identification of moderating patient-level factors for risk and benefit. The project's overall goal is to determine optimal tooth brushing frequency for mechanically ventilated adults. Optimal tooth brushing frequency is important for control of dental plaque and reduction of oral inflammation;it is likely to improve patient comfort, improve efficiency of nursing care, and may reduce systemic sequellae related to oral inflammation. The primary aims of the proposed project are: 1) Evaluate the clinical equivalence (non- inferiority) o three tooth brushing frequencies on oral health (dental plaque and mucosal inflammation) in critically ill adults receiving mechanical ventilation;and 2) Quantify and compare the safety of three tooth brushing frequencies on serious adverse outcomes, including ventilator associated complications and clinically relevant HAIs. A secondary aim is to investigate patient factors that influence tooth brushing frequency benefit and risk in critically ill adults. These objectives willbe accomplished using a prospective, randomized, experimental design. Subjects (n=345) will be randomly assigned within 24 hours of intubation to one of three intervention groups which differ in frequency of tooth brushing delivered by study personnel (once, twice, or three times daily). Dental plaque (UM-OHI score, with observations documented and augmented by use of a digital intraoral camera), mucosal inflammation (gingival crevicular fluid IL-1?), and HAIs will be assessed daily during the intervention period. The data analysis will focus on providing definitive clinical practice guidance through joint evaluation of non-inferiority (comparison of dental plaque between groups by analysis of covariance) and quantification of number needed to harm. Repeated measures linear mixed models (treating dental plaque and mucosal inflammation as separate outcome variables) will provide insight as to specific patient-level factors that may modify the clinical effectiveness and safety profile associated with frequency of tooth brushing. Information about efficacy and safety of each frequency of tooth brushing will provide a clear recommendation for optimal tooth brushing frequency with direct translation to clinical practice.

Public Health Relevance

There is little evidence about how frequently the teeth of mechanically ventilated adults should be brushed, and benefits and risks of brushing once, twice, or three times a day have not been compared. This project will determine the optimal frequency for tooth brushing in mechanically ventilated adults, which is important to remove dental plaque and reduce inflammation in the mouth while minimizing potential risks of tooth brushing. Results of the project are also likely to improve patient comfort and efficiency of nursing care.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Research Project (R01)
Project #
2R01NR007652-10A1
Application #
8753246
Study Section
Nursing and Related Clinical Sciences Study Section (NRCS)
Program Officer
Huss, Karen
Project Start
2001-04-01
Project End
2018-07-31
Budget Start
2014-09-10
Budget End
2015-07-31
Support Year
10
Fiscal Year
2014
Total Cost
$464,383
Indirect Cost
$143,484
Name
University of South Florida
Department
None
Type
Schools of Nursing
DUNS #
069687242
City
Tampa
State
FL
Country
United States
Zip Code
33612
Jones, Deborah J; Munro, Cindy L; Grap, Mary Jo (2011) Natural history of dental plaque accumulation in mechanically ventilated adults: a descriptive correlational study. Intensive Crit Care Nurs 27:299-304
Munro, Cindy L; Grap, Mary Jo; Jones, Deborah J et al. (2009) Chlorhexidine, toothbrushing, and preventing ventilator-associated pneumonia in critically ill adults. Am J Crit Care 18:428-37;quiz 438
Munro, Cindy L; Grap, Mary Jo; Jablonski, Rita et al. (2006) Oral health measurement in nursing research: state of the science. Biol Res Nurs 8:35-42
Munro, Cindy L; Grap, Mary Jo (2004) Oral health and care in the intensive care unit: state of the science. Am J Crit Care 13:25-33; discussion 34