| Methods |
Design: four group parallel trial
Purpose: examine the effect of cognitive‐behavioural therapy on oral hygiene |
| Participants |
Patients: veteran out‐patients with normal oral hygiene
Baseline comparability: yes |
| Interventions |
Placebo: sessions of lectures on non‐disease aspects of dentistry
Untreated: no sessions
Experimental: sessions of cognitive‐behavioural therapy
(Co‐intervention: NS) |
| Outcomes |
Brushing frequency (per week) and Plaque Index
Flossing frequency |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/cognitive‐behavioural therapy) |
| Blinding?
Outcome assessor |
Low risk |
'The dentist that rated plaque levels was blind to each subject's assigned experimental group' |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 50 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
