Bellomo 2005.

Methods	Randomised controlled trial, 2 arms (each with 2 subgroups: independent and assisted) Study period: not reported Planned follow‐up period: 6 months
Participants	Country: Switzerland Setting: long‐term care home Target audience for intervention: long‐term care home residents Number of randomised participants (long‐term care home residents): 61 Number of analysed participants (long‐term care home residents): 61 Age, mean, years: 85.4 in IG, 86.8 in CG (range for both groups 72 to 97 years) Female: 73.3% in IG, 71% in CG Edentulous: 36.7% in IG, 35.6% in CG Residents with dental prosthesis: 80% (of all participants) Inclusion criteria: residents of the long‐term care home (irrespective of state of (oral) health) Exclusion criteria: n/a
Interventions	Intervention group 2 subgroups (one with independent residents (IG1) and one with residents who are in need of assistance (IG2)): Instruction/skills training: IG1: initial occupational therapy instruction on tooth and denture brushing IG2: initial occupational therapy instructions on tooth and denture brushing followed by weekly monitoring and if necessary re‐education. The monitoring consisted of guidance and "gesture/movement education" during the tooth and denture brushing. Education: Educational lecture for medical/nursing staff of the long‐term care home (aiming to raise awareness of dental hygiene needs of the residents, motivation to support the study) Control group 2 subgroups (one with independent residents (CG1) and one with residents who are in need of assistance (CG2)) CG1: usual care CG2: weekly occupational therapy employing "placebo" interventions, like a manicure carried out by the same occupational therapist Education: Educational lecture for medical/nursing staff of the long‐term care home (aiming to raise awareness of dental hygiene needs of the residents, motivation to support the study) Co‐interventions n/a
Outcomes	Primary outcomes Oral hygiene measures, level of autonomy (brushing), and residents' oral health‐related behaviour were assessed at baseline, 3 and 6 months after start of the study Dental plaque: Plaque Index (Silness 1964) Denture plaque: Denture Plaque Index (Ambjørnsen 1982) Level of autonomy (ability to brush teeth/dentures): scored by an occupational therapist using a scale from 0 to 3.5 (Residents') oral health‐related behaviour: interview on oral hygiene habits
Funding	Not reported
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information in the paper (correspondence: "randomisation was done by the nursing home via the patient allocation list (availability of rooms) in either one building or the other. no computer sequence generation etc.")
Allocation concealment (selection bias)	High risk	Insufficient information in the paper (correspondence: "no concealment")
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Groups corresponded to 2 separate buildings, which assured blinding of participants to the other study arm.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Insufficient information in the paper (correspondence: "outcome assessor was not blinded")
Incomplete outcome data (attrition bias) All outcomes	Low risk	"Two participants passed away during the experimental period and were excluded from analysis." (study group affiliation unclear)
Selective reporting (reporting bias)	Unclear risk	Correspondence: protocol not available, no trial registration
Other bias	Low risk	None apparent