Berry 2013.

Methods	Study design: 3‐arm parallel‐group RCT Location: Australia Number of Centres: 1 Study period: Not stated Funding source: Pfizer provided product only
Participants	Setting: ICU in a 1000‐bed tertiary referral teaching hospital Inclusion criteria: admitted to ICU, able to be randomised within 12 hours of intubation; aged over 15 years; next‐of‐kin able to give informed consent Exclusion criteria: required specific oral hygiene procedures following facio‐maxillary or dental trauma/surgery; had received irradiation or chemotherapy on admission to the ICU or in the preceding 6 weeks; diagnosed with autoimmune disease; had previous ICU admission during current period of hospitalisation Number randomised: 398 (Group A: 138; Group B: 133; Group C: 127) Number evaluated: 398 (Group A: 138; Group B: 133; Group C: 127); however, 11% of these participants were ineligible Baseline characteristics: ‐ Group A: Age: 58.82 (16.7); M/F: 84/54; APACHE II Score: 20.86 (7.7) ‐ Group B: Age: 54.93 (19.5); M/F: 79/54; APACHE II Score: 21.38 (8.0) ‐ Group C: Age: 59.96 (18.0); M/F: 73/54; APACHE II Score: 21.21 (8.0)
Interventions	Comparison: Sterile water versus sodium bicarbonate versus Listerine Group A: Control – sterile water mouth rinses, 20 ml every 2 hours. Group B: Sodium bicarbonate mouth wash (6.5 g/L sterile water), 20 ml every 2 hours. Group C: Listerine mouth wash, 20 ml instilled twice a day and sterile water every 2 hours for remaining time All 3 groups received mechanical cleaning of the oral cavity with a small, soft‐bristled toothbrush and general‐purpose toothbrush 3 times a day. Curved‐tip dental syringes were used to instill mouth rinses. During the study period, VAP preventive measures including head of the bed elevation, stress ulcer prophylaxis and endotracheal cuff occlusive pressure between 22 and 30 cm H2O were maintained.
Outcomes	1. Incidence of VAP 2.Dental plaque colonisation 3. Systemic antibiotic administration (unclear if systemic) 4. Adverse effects
Notes	Sample size calculation: reported for inhibition of microbial growth on dental plaque, not VAP Emailed study investigator 10 April 2016 for publication details or full unpublished study data
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Randomisation numbers were computer generated”
Allocation concealment (selection bias)	Low risk	“Nurses were blinded to the study option until the study packs were opened”
Blinding of participants and personnel (performance bias) All outcomes	High risk	Nurses were not blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	“Microbiologists … and … radiologists also blinded to the treatment code”
Incomplete outcome data (attrition bias) All outcomes	High risk	245 randomised participants (62%) were no longer in the study on the 4th day; Intention‐to‐treat analysis was used but unsure how and whether appropriate
Selective reporting (reporting bias)	High risk	VAP data were only presented as percentages; 24 participants died within 4 days but unclear how many died after that; exact data for systemic antibiotic administration was not reported.
Other bias	Unclear risk	Ineligible patients were included in the ITT but reasons for ineligibility in each group were not given