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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-6pq736 |
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Date of registration:
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07/09/2011 |
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Primary sponsor: |
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Public title:
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Oral Care and Pneumonia in Institutionalized Elderly
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Scientific title:
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Efficacy of Oral Hygiene Practices on Aspiration Pneumonia Oral Pathogens in Elderly Nursing Home Residents |
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Date of first enrolment:
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01/01/2010 |
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Target sample size:
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108 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-6pq736/ |
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Study type:
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Study design:
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Clinical trial, double-blind, randomized, controlled, with three arms
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Maria
Aguiar |
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Address:
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Av. Afonso Pena 1081 Tirol
59020100
Natal - RN
Brazil |
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Telephone:
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(84)30861671 |
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Email:
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mariaceciliaaguiar@yahoo.com.br |
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Affiliation:
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PPGASC |
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Name:
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Elizabete
Araújo de Oliveira |
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Address:
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Av. Marechal Campos, 1468 Maruípe
29040-090
Vitória
Brazil |
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Telephone:
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(27) 4009-7287 |
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Email:
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elizabete_regina@hotmail.com |
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Affiliation:
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PPGASC |
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Key inclusion & exclusion criteria
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Inclusion criteria: Being elderly (older than 60 years old) and to live at the long-term care facility selected for the research
Exclusion criteria: Diagnosis of neoplastic or infectious disease during the study stages; Inability to breathe or feed by natural means (dependence on mechanical ventilators or feeding tubes); Need for antimicrobial therapy or hospitalization in the three months prior to intervention; Dependence on immunosuppressive drugs; Diagnosis of Sjögren's syndrome; Persons who had received radiotherapy with irradiation field covering the head and neck.
Age minimum:
60Y
Age maximum:
100Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Pneumonia C08.381.677.529
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Intervention(s)
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Isolated mechanic measures of oral hygiene was compared to mechanic measures associated with 0,12% chlorhexidine gluconate, in elderly living in Juvino Barreto Institute, Long-term care institution for the elderly in Natal - RN.
In group A, there were only mechanical oral hygiene measures, which consisted of brushing the teeth with extra soft toothbrush without toothpaste, cleaning the tongue with tongue scraper and cleaning of the oral soft tissues with sterile gauze pads soaked in saline.
In group B, we performed the same mechanical hygiene measures in group A, and added the use of aqueous chlorhexidine 0.12%.
In group C (control), no measure of oral hygiene was used. The participants performed themselves the hygiene routines already used before the study.
In the study groups, oral hygiene measures lasted fifteen days. This stage of the study lasted four months.
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Primary Outcome(s)
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Clinical behavior of oral microbiota, assessed by visual analysis of the accumulation of tongue coating (categories: present or absent) by the examiner of the study
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Presence and levels of oral colonization by Staphylococcus aureus, Staphylococcus coagulase negative (SCN) and total aerobic, by counting the colony forming units (CFU) of microorganisms with growth in specific culture media
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Secondary Outcome(s)
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Age (As of 60 years, given in years)
gender (male and female)
Oral health conditions: - Number of teeth present (0-32) - DMF-d (index that corresponds to the sum of number of decayed, missing and filled. It ranges from 0 to 32) - Use of dentures (yes or no) - oral hygiene (method and frequency) - Changes in the soft tissues (yes or no. type to be specified, when present)
Present systemic comorbidities (cerebrovascular diseases, neurological disorders, diabetes and arthritis, among others)
continued use of drugs
degree of functional independence (independent, partially dependent or totally dependent)
Time of study (baseline, time zero and time fifteen) .
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Secondary ID(s)
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0052.0.051.051-07
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Source(s) of Monetary Support
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Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brazil
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