| Methods |
Design: three group parallel trial
Purpose: examine the effect of sustained release delivery system of chlorhexidine on oral hygiene of patients with Down's syndrome |
| Participants |
Patients: institutionalised with Down's syndrome
Baseline comparability: NS |
| Interventions |
Placebo: teeth coating without chlorhexidine
Untreated: no teeth coating
Experimental: teeth coating with chlorhexidine
(Co‐intervention: penicillin before scaling and polishing teeth, normal oral hygiene) |
| Outcomes |
Plaque index
Gingival index
Papillary bleeding
Plaque bacterial counts |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'The study was double‐blind...' |
| Blinding?
Outcome assessor |
Low risk |
'... the examiner was not aware which treatment was given' |
| 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? |
High risk |
N = 20 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
