- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01294943
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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São Paulo, Brazil, 04122-000
- Hospital Santa Cruz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Tongue cleaner
Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation.
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Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bauru School of Dentistry, USP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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