| Methods |
Design: three group parallel trial
Purpose: study the effect of penicillin troches for recurrent aphthous ulcers |
| Participants |
Patients: outpatients with recurrent aphthous ulcers
Baseline comparability: yes (age, gender, ulcer age) |
| Interventions |
Placebo: sessions with TENS device not producing nerve stimulation
Untreated: no sessions
Experimental: sessions TENS device producing nerve stimulation
(Co‐intervention: installation of 4% lidocaine gel) |
| Outcomes |
Proportion of patients with healed ulcers
Proportion of patients with no pain |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
urn randomisation '...the subject drawing a single envelope from a pool of sealed blank envelopes' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'Both the investigators and treatment group subjects were blinded' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
Low risk |
N = 69 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
