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The effect of chlorhexidine on the incidence of aspiration pneumonia in care home residents: design of a double-blind cluster randomized placebo-controlled trial.

The influence of the addition of rinsing with a 0.05% chlorhexidine-containing solution to usual daily oral hygiene care on the incidence of aspiration pneumonia in physically-impaired care home residents with dysphagia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28334
Enrollment
500
Registered
2012-07-09
Start date
2013-02-14
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral health care, chlorhexidine, aspiration pneumonia, dysphagia, care home

Interventions

The intervention consists of the addition of rinsing with a 0.05% chlorhexidine-containing solution twice daily immediately after the usual oral hygiene care. The execution of the intervention is depe

Sponsors

Department of Dentistry, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Residents: 1. Aged 65 years or older; 2. Physically impaired; 3. Dysphagia diagnosed using the DSS by a speech therapist.

Exclusion criteria

Exclusion criteria: Residents: 1. Cognitively impaired; 2. In coma or vegetative state; 3. Terminally ill; 4. Dependent on mechanical ventilation; 5. In day-care or in short-term care; 6. Slready using an oral rinse.

Design outcomes

Primary

MeasureTime frame
To assess the influence of the addition of rinsing with a 0.05% chlorhexidine-containing solution to usual daily oral hygiene care on the incidence of pneumonia in physically-impaired care home residents with dysphagia.

Secondary

MeasureTime frame
To assess the correlation between some medical, physical, and oral conditions (age, gender, diseases diagnosed, care dependency, medication use, number of teeth and implants present, and presence of removable dentures ) and the incidence of aspiration pneumonia in physically-impaired, older care home residents with dysphagia who rinse with a 0.05% chlorhexidine-containing solution or a placebo in addition to usual daily oral hygiene care.

Contacts

Public ContactVanessa Hollaar

Department of Neurohabilitation HAN University of Applied Sciences Nijmegen Postbus 6960

v.hollaar@denthy.umcn.nl+31 (0)24 3616365

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)