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. 2016 Sep 30;2016(9):CD010535. doi: 10.1002/14651858.CD010535.pub2

MacEntee 2007.

Methods Cluster‐randomised controlled trial, 2 arms
Study period: not reported
Planned follow‐up: 3 months
Participants Country: Canada
Setting: 14 long‐term care facilities
Target audience for intervention: care‐aides
Number of randomised participants (nursing home residents with intermediate care): 127
Number of analysed participants (nursing home residents with intermediate care): 113
Age, mean, years: 78.3 in IG, 79.9 in CG
Female: not reported
Edentulous: excluded
Residents with dental prosthesis: not reported
Inclusion criteria: residents receiving intermediate care, with natural teeth, and cognitively and physically suitable for a clinical examination of the mouth
Exclusion criteria: not explicitly stated
Interventions Intervention group
Pyramidal education consisting of the following.
Education/skills training:
  • nurse educator training (including an annotated series of clinical photographs and texts summarising the appearance and management of oral diseases among frail elderly) for a permanent member of the nursing staff by a dental hygienist

  • single seminar (1 hour) for care‐aides conducted by the nurse educator comprising a theoretical part with photographs and texts, and demonstration with props of how to examine and clean the mouth


Information material:
  • copy of the text for care‐aides attending the seminar

  • access to the photographs for care‐aides attending the seminar


Additional components:
  • nurse educator (managing the oral health care provided by the care aides)

  • nurse educator had direct access to the dental hygienist by telephone for further information/advice as needed

  • dental hygienist contacted nurse educator within 2 weeks of their meeting to offer additional guidance


Control group
Usual routine (comprises the same 1‐hour seminar with photographs, texts, and demonstrations but delivered directly to the care‐aides by the dental hygienist. No additional information or support.)
Co‐interventions
n/a
Outcomes Primary outcomes
Oral hygiene measures were assessed at baseline and 3 months after the seminar.
  • Dental plaque: Geriatric Simplified Debris Index (Greene 1967)

  • Gingivitis: Gingival Bleeding Index (Ainamo 1975)


Secondary outcomes
Clinical measures of dietary nourishment and masticatory potential were assessed at baseline and 3 months after the seminar.
  • body mass index (BMI)

  • Malnutrition Indicator Score (MIS)

  • masticatory potential: Eichner index


Additional outcomes: psychosocial outcomes were assessed using qualitative research methods (questionnaires, interviews).
Funding BC Medical Service Foundation Grant
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomised block design"; correspondence: "generated from a programme by a research assistant"
Allocation concealment (selection bias) Low risk Quote: "A person not involved in the education or analysis of results performed the random selections and assignments, and broke the code when all data were collected."
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "double‐blind.... Neither the examiner nor the residents knew the intervention assignments."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "The examiner or assistant did not know the educational method assigned to the facilities, nor did they know the results from the baseline examinations when examining the residents 3 months later."
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Data for outcomes (gingival bleeding score, tab. 3) were not collected from all participants due to some participants being unable or unwilling to co‐operate fully.
Losses to follow‐up comparable in intervention (N = 8) and control group (N = 6).
Selective reporting (reporting bias) Low risk Insufficient information in published study report, additional data provided on request.
Results of the psychosocial aspects not published/not available.
Other bias Unclear risk Possible recruitment bias (insufficient information)