Evaluating the Effectiveness of the Tongue Cleaner in Critical Patients

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01294943
Collaborator
(none)
50
1
23
2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Tongue cleaner

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluating the Effectiveness of the Tongue Cleaner in Patients Wholly or Partially Dependent Care
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Tongue cleaner

Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation.

Device: Tongue cleaner
Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Santa Cruz São Paulo Brazil 04122-000

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paulo Sergio da Silva Santos, DDS, MD, PhD, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT01294943
    Other Study ID Numbers:
    • Bauru School of Dentistry, USP
    First Posted:
    Feb 14, 2011
    Last Update Posted:
    Aug 15, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Paulo Sergio da Silva Santos, DDS, MD, PhD, University of Sao Paulo
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 15, 2012