Lorente 2012.

Study characteristics
Methods	Study design: Parallel‐group RCT Location: Tenerife, Spain Number of centres: 1 Study period: August 2010 to August 2011 Funding source: Hospital funding
Participants	Setting: medical/surgical ICU Inclusion criteria: consecutive patients undergoing invasive mechanical ventilation for at least 24 hours Exclusion criteria: edentulous, aged < 18 years, pregnant, HIV positive, white blood cells < 1000 cells/mm3, solid or haematological tumour, immunosuppressive therapy, mechanical ventilation duration < 24 hours Number randomised: 436 (217/219) Number evaluated: 436 Baseline characteristics: ‐ Intervention group: age: 61.0 ± 15.6 years; M/F: 146/71 ‐ Control group: age: 60.4 ± 16.6 years; M/F: 145/74
Interventions	Toothbrushing + 0.12% chlorhexidine gel vs chlorhexidine alone Experimental group (n = 217): oral cleansing performed with 0.12% chlorhexidine‐impregnated gauze, and oral cavity injection, followed by manual brushing of the teeth with a brush impregnated with 0.12% chlorhexidine (tooth by tooth on the anterior and posterior surfaces, the gum line and the tongue for a period of 90 seconds) Control group (n = 219): oral cleansing performed with 0.12% chlorhexidine‐impregnated gauze, and oral cavity injection only In both groups, nurse performed oral care every 8 hours. First endotracheal cuff pressure was tested, oropharyngeal secretions were aspirated, then chlorhexidine‐impregnated gauze was used to cleanse the teeth, tongue and mucosal surfaces, followed by injection of 10 mL 0.12% of chlorhexidine digluconate into oral cavity, and finally after 30 seconds the OParea was suctioned.
Outcomes	1. Incidence of VAP 2. Duration of ventilation 3. ICU mortality 4. Tracheal colonisation with gram +ve & ‐ve organisms 5. Antibiotic exposure
Notes	Sample size calculation: estimated that 218 participants required in each group to give 80% power and α error of 5%, to show a reduction in VAP from 15% to 7.5%
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"...a list of random numbers generated with Excel software (Microsoft, Seattle, WA)"
Allocation concealment (selection bias)	Unclear risk	No information about allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"The diagnosis of VAP was made by an expert panel, blinded to group assignment".
Incomplete outcome data (attrition bias) All outcomes	Low risk	All randomised participants are included in the outcome evaluations.
Selective reporting (reporting bias)	Low risk	Planned outcomes reported in full
Other bias	Low risk	No other sources of bias identified