Skip to main content
. 2016 Sep 8;2016(9):CD008802. doi: 10.1002/14651858.CD008802.pub3

3. Suggested trial design.

Method Allocation: randomised, clearly described
 Blinding: double blinded, described and tested
 Duration: 6 months
Participants Diagnosis: thought to have psychoses
 N = 300*
 Age: any
 Sex: both male and female
 History: acutely ill, aggressive
Intervention 1. Oral health education (advice and training)
2. Monitoring
 3. Treatment as usual
Outcomes Specific behaviours: self harm, including suicide, injury to others, aggression
 Global outcomes: overall improvement, use of additional medication, use of restraints/seclusion
 Service outcomes: duration of hospital stay, re‐admission
 Mental state: no clinically important change in general mental state
 Adverse events: clinically important adverse events
 Leaving the study early: reason
 Economic outcomes
Notes *Powered to be able to identify a difference of ˜20% between groups for primary outcome with adequate degree of certainty