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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.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-6pq736
Date of registration: 07/09/2011
Primary sponsor: Universidade Federal do Espírito Santo - Brazil
Public title: Oral Care and Pneumonia in Institutionalized Elderly
Scientific title: Efficacy of Oral Hygiene Practices on Aspiration Pneumonia Oral Pathogens in Elderly Nursing Home Residents
Date of first enrolment: 01/01/2010
Target sample size: 108
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-6pq736/
Study type: 
Study design:  Clinical trial, double-blind, randomized, controlled, with three arms  
Countries of recruitment
Brazil
Contacts
Name: Maria  Aguiar
Address:  Av. Afonso Pena 1081 Tirol 59020100 Natal - RN Brazil
Telephone: (84)30861671
Email: mariaceciliaaguiar@yahoo.com.br
Affiliation:  PPGASC
Name: Elizabete  Araújo de Oliveira
Address:  Av. Marechal Campos, 1468 Maruípe 29040-090 Vitória Brazil
Telephone: (27) 4009-7287
Email: elizabete_regina@hotmail.com
Affiliation:  PPGASC
Key inclusion & exclusion criteria
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: -
Health Condition(s) or Problem(s) studied
Pneumonia
C08.381.677.529
Intervention(s)
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.
Primary Outcome(s)
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
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
Secondary Outcome(s)
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) .
Secondary ID(s)
0052.0.051.051-07
Source(s) of Monetary Support
Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brazil
Secondary Sponsor(s)
Maria Cecilia Azevedo de Aguiar - Brazil
Programa de Pós-Graduação em Saúde Coletiva da Universidade Federal do Espírito Santo - Brazil
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