Oral Care to Reduce Mouth and Throat Infections in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00078663
Recruitment Status : Completed
First Posted : March 4, 2004
Last Update Posted : July 2, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

March 3, 2004
March 4, 2004
July 2, 2017
March 2, 2004
December 28, 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00078663 on Archive Site
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Oral Care to Reduce Mouth and Throat Infections in Critically Ill Patients
The Effect of a Systemic Oral Care Program on Reducing Exposure to Oropharyngeal Pathogens in Critically III Patients

This study will evaluate whether a program of systematic oral care can help prevent hospital-acquired respiratory infections in patients in intensive care units. Such infections occur five times more often in critically ill patients compared with patients in general hospital wards and result in longer hospital stays and an increased risk of death. The rate of respiratory infection among critically ill patients correlates strongly with the presence of disease-causing bacteria in the mucosal areas of the mouth, gums, and teeth, indicating that assiduous oral care is especially important in this patient population. This study will compare a program of meticulous oral care using oral assessments taught by a dentist and dental hygienist with the standard care typically given in intensive care units.

Critically ill patients 18 years of age and older who are hospitalized in an intensive care unit for 3 or more days and whose oral hygiene is dependent on hospital care providers may be eligible for this study. Patients will be recruited from intensive care units at four Washington, D.C., area hospitals - Suburban Hospital, Washington Hospital Center, Inova Fairfax Hospital, and Winchester Medical Center.

Participants will have their lips, mouth, gums, teeth, and saliva examined several times a day to determine their optimum oral care. They will receive standard care, such as flossing, brushing, rinsing with a mouthwash, and possibly use of an antiseptic spray that prevents bacteria from clinging to the teeth. Small samples of saliva (less than one-fourth of a teaspoon) and dental plaque will be collected the day the patient is admitted to the intensive care unit and again on days 3 and 5 of their stay in the unit. The saliva sample is collected with a small suction tube placed in the corner of the mouth; the plaque specimen is collected by gliding a tiny piece of paper over the surface of a front tooth. The samples will be examined for any bacteria not normally found in saliva.

Critically ill patients, especially those that require endotracheal intubation, have the greatest risk of any hospitalized patient for acquiring nosocomial pneumonia. Nosocomial pneumonia, in this population, produces a substantial increase of mortality and morbidity. The literature suggests the causative pathway is aspiration of oropharyngeal pathogens found in dental plaque. The build-up of dental plaque has been significantly associated with subsequent nosocomial respiratory infections. Thus, prevention of pathogens colonization in the oropharyngeal cavity could be an effective infection control measure.

Dental plaque once it reaches a critical thickness, acts as a reservoir for both aerobic and anaerobic pathogens. Failure to remove plaque begins a complex cascade of biological activity by which pathogens adhere to mucosal and tooth surfaces and pathogen overgrowth ensues. Additionally, neglected or insufficient mouth care is the foremost predisposing factor to oral conditions such as gingivitis, mucositis, and stomatitis which supply additional ports of entry for pathogens.

There are only a handful of studies that compare the frequency and type of oral hygiene required to prevent or decrease oropharyngeal colonization. A recent pilot study, 01-CC-0207, compared oral care provision in two intensive care units (ICU) in the Clinical Center. The test ICU offered meticulous oral hygiene through a system of regular oral assessments taught by a dentist and dental hygienist. The score from the assessment determined the type and frequency of oral care. The control ICU gave standard care typical of the ICU community. Plaque and saliva assays were collected from the enrolled patients. Significantly lower Beck scores and lower colony forming organisms in the specimens was achieved in the test ICU on day 3, p less than 0.03 and p less than 0.001 respectively.

This protocol will expand the pilot into a prospective randomized assigned trial conducted at four hospitals in the Washington D.C. area. These hospitals have ICUs more representative of ICU's nation-wide. This study will test the effectiveness of a comprehensive and systematic oral care program to reduce the oral assessment scores, mucosal plaque scores, and the amount of pathogen inoculum present in the saliva and plaque. Intubated and non-intubated patients will be compared as well as meticulous care with or without the addition of the oral antiseptic, chlorhexidine. Consistency of practice performance will also be evaluated when nursing staff has dentist/hygienist instruction and monitoring versus the traditional nurse instruction.

Phase 3
Primary Purpose: Treatment
Critical Illness
Behavioral: Oral Care
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 16, 2011
December 28, 2007   (Final data collection date for primary outcome measure)
  • Male or female adult ICU patients whose oral hygiene is dependent upon hospital care providers.
  • Expected length of ICU stay is greater than or equal to 3 days.
  • Any gender and ethnicity.


  • Individuals and or responsible family members who are unable to provide consent.
  • Any individual under the age of 18 years.
  • Any individual whose expected admission is less than 3 days.
  • Adult ICU patients whose admission CPIS score is greater than 6.
  • Individuals who are able to provide own oral care.
  • Individuals who have oral surgery that requires specialized oral care and assessment.
  • Edentulous patients.
  • Any patient with a prosthetic heart valve or who routinely takes prophylactic antibiotics before routine dental procedures.
  • Any patient with a known allergy to chlorhexidine.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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National Institutes of Health Clinical Center (CC)
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National Institutes of Health Clinical Center (CC)
August 16, 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP