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Evaluating the Effectiveness of the Tongue Cleaner in Critical Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paulo Sergio da Silva Santos, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01294943
First received: February 11, 2011
Last updated: August 14, 2012
Last verified: August 2012

February 11, 2011
August 14, 2012
January 2010
June 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01294943 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Evaluating the Effectiveness of the Tongue Cleaner in Critical Patients
Evaluating the Effectiveness of the Tongue Cleaner in Patients Wholly or Partially Dependent Care

The concern with oral infection and its systemic repercussions is old, many studies have been undertaken to establish this relationship more precisely. One of the areas mouth still little studied in this regard is the colonization of language within this universe of the oral microbiota colonization and how this may affect the general state of health care-dependent individuals.

This research aims to evaluate the efficiency of a tongue cleaning device and its potential impacts on infectious patients fully or partially dependent care hospital.

Patients admitted to intensive care units and inpatient units will be evaluated, divided into two groups: Study Group (SG) - Patients who receive oral hygiene using the tongue cleaning device, and Control Group (CG) - Patients who are cared for according to the routine of hospital nursing.

Patients admitted to intensive care units and inpatient units will be evaluated, divided into two groups: Study Group (SG) - Patients who receive oral hygiene using the tongue cleaning device, and Control Group (CG) - Patients who are cared for According to the routine of hospital nursing.

The criteria for inclusion of elements of the research will follow the criteria of dependence of patients on mechanical ventilation, if they are or not. Patients fully or partially dependent care are patients who can not make your oral hygiene alone and dependent on another individual to do so, if a hospital staff member health. Exclusion criteria will be based on condition of dependency of the patient, intubation period under 48 hours and if one refuses to participate in the research.

Patients will first be evaluated by a dentist, doctor and nursing, which together decide on the inclusion of patients in the study based on the criterion of seriousness of the patient by APACHE. The assessment will follow the clinical criterion of presence or absence of tongue biofilm (Adachi 2005), and the collection swab with biofilm lingual to perform culture and sensitivity. These assessments take place twice within five days, being held in the first and fifth days. During this period the patients participating in the GE will hygienic tongue using tongue cleaner (Tepe ®) and other standardized oral hygiene care by the nursing team previously coached by dentist. CG patients receive the standard oral hygiene care with a spatula and gauze soaked in mouthwash and tongue will not use the tongue cleaner.

For the assessment of plaque and tongue of sample qualitative material for culture and sensitivity attend three calibrated dentists.

For this study 25 patients will be assessed for EG and 25 for GC, a total of 50 patients evaluated, and 100 samples of material collected.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

tongue biofilm

Probability Sample

Patients undergoing intubation in the intensive care unit

  • Oral Infection
  • Ventilator-associated Pneumonia
Device: Tongue cleaner
Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation.
Tongue cleaner
Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation.
Intervention: Device: Tongue cleaner
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The criteria for inclusion of elements of the research will follow the criteria of dependence of patients on mechanical ventilation they are or not. Patients fully or partially dependent care are patients who can not make your oral hygiene alone and dependent on another individual to do so, if a hospital staff member health.

Exclusion Criteria:

  • Condition of not being dependent on the patient
  • Intubation period under 48 hours
  • If one refuses to participate in the research
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01294943
Bauru School of Dentistry, USP
Yes
Paulo Sergio da Silva Santos, University of Sao Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
August 2012

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