title: Effect of daily application of a 0.05% chlorhexidine solution on the incidence of (aspiration) pneumonia in care home residents: design of a multicentre cluster randomised controlled clinical trial.
abstract: BACKGROUND
  Pneumonia is an important cause of death in care home residents. Dysphagia and poor oral health are significant risk factors for developing aspiration pneumonia. Oral hygiene care reduces the number of oral bacteria and the risk of aspiration pneumonia. However, it is not clear yet which oral hygiene care intervention is most efficacious in reducing the risk of aspiration pneumonia. The aim of the study is to assess whether the application of a 0.05% chlorhexidine-containing solution in addition to the usual daily oral hygiene care reduces the incidence of pneumonia in physically disabled care home residents with dysphagia.
  
  
  METHODS
  The study was designed as a multicentre cluster randomised controlled clinical trial, with care homes as units of randomisation. During 1 year, 500 physically disabled care home residents with dysphagia will be followed. The intervention consists of applying a 0.05% chlorhexidine-containing solution twice daily, immediately after the usual oral hygiene care, whereas the control group receives no application after the usual oral hygiene care. The primary outcome is the incidence of pneumonia diagnosed by a physician, using a set of strictly described criteria. The effect of the intervention on the incidence of pneumonia will be determined using a Cox regression analysis. The secondary outcomes are correlations between incidence of pneumonia, age, gender, diagnosed diseases, dysphagia severity, care dependency, actually used medication, number of teeth and implants present and the presence of removable dentures.
  
  
  BACKGROUND
  Ethical approval was obtained from the Medical Ethical Committee of Radboud university medical centre: NL.nr: 41990.091.12. Written and informed consent will be obtained from all participating care homes and residents. The study's findings will be published in peer-reviewed journals.
  
  
  BACKGROUND
  The trial has been registered in the Netherlands in the National Trial Register: TC=3515.
authors.affiliation: BENECOMO, Flemish-Netherlands Geriatric Oral Research Group, Nijmegen, The Netherlands Department of Neurorehabilitation, HAN University of Applied Sciences, Nijmegen, The Netherlands Department of Oral Function and Prosthetic Dentistry, Radboud University Medical Centre, Nijmegen, The Netherlands.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Hollaar
authors.affiliation: BENECOMO, Flemish-Netherlands Geriatric Oral Research Group, Nijmegen, The Netherlands Center for Special Care in Dentistry, Amsterdam, The Netherlands.
authors.forename: Claar
authors.initials: C
authors.lastname: van der Maarel-Wierink
authors.affiliation: BENECOMO, Flemish-Netherlands Geriatric Oral Research Group, Nijmegen, The Netherlands Department of Oral Function and Prosthetic Dentistry, Radboud University Medical Centre, Nijmegen, The Netherlands Amaris Gooizicht, Hilversum, The Netherlands.
authors.forename: Gert-Jan
authors.initials: GJ
authors.lastname: van der Putten
authors.affiliation: Department of Neurorehabilitation, HAN University of Applied Sciences, Nijmegen, The Netherlands Division Speech Therapy, Department of Rehabilitation, Radboud University Medical Centre, Nijmegen, The Netherlands.
authors.forename: Bert
authors.initials: B
authors.lastname: de Swart
authors.affiliation: BENECOMO, Flemish-Netherlands Geriatric Oral Research Group, Nijmegen, The Netherlands Department of Oral Function and Prosthetic Dentistry, Radboud University Medical Centre, Nijmegen, The Netherlands.
authors.forename: Cees
authors.initials: C
authors.lastname: de Baat
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage*; D002710:Chlorhexidine / Q000008:administration & dosage*; D003680:Deglutition Disorders / Q000150:complications; D016330:Frail Elderly; D006707:Homes for the Aged; D006801:Humans; D015994:Incidence; D009067:Mouthwashes / Q000008:administration & dosage*; D009426:Netherlands; D009735:Nursing Homes; D011015:Pneumonia, Aspiration / Q000453:epidemiology* / Q000517:prevention & control; D012307:Risk Factors
chemical_list: D000891:Anti-Infective Agents, Local; D009067:Mouthwashes; D002710:Chlorhexidine
keywords: GERIATRIC MEDICINE; ORAL MEDICINE