Recurrent Aphthous Stomatitis
Conditions
Keywords
Sodium lauryl sulfate (SLS), recurrent aphthous stomatitis (RAS), dentifrice, pain
Brief summary
Sodium lauryl sulfate (SLS) is an anionic detergent that has been used as the major or sole surfactant in most dentifrices. But it is known to local irritating factor to oral mucosa and skin and results in many side effects. This study was to compare the effects of SLS-free dentifrice and SLS-containing dentifrice in patients with recurrent aphthous stomatitis (RAS).
Interventions
The subjects were divided into three groups, each of which comprised 30 randomly assigned subjects: group I used SLS-free(a commercially available SLS-free dentifrice(Wiconi® dentifrice) and SLS-A (a dentifrice containing 1.5%; Wiconi® dentifrice + 1.5% SLS). The subjects used one of the two assigned dentifrices for 8 weeks, and then the other for the following 8 weeks. The order of the dentifrices used was selected at random, and there was a 2-week washout period between the two phases, during which the subject used the same dentifrice as they used before participating in this study. The subjects were asked to brush their teeth using their usual toothbrushing method with the dentifrice and toothbrush supplied.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The volunteers had a history of regularly recurring oral ulcerations of at least 6 months duration, with more than one episode per month
Exclusion criteria
* already using an SLS-free dentifrice * taking medications affecting oral ulcers (e.g., corticosteroids) * having chronic oral mucosal disease (ex, lichen planus, pemphigus vulgaris, pemphigoid, and etc.) * having allergies to food or medications * being pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of episodes | after 18 weeks | Sum of the number of episodes experienced by the subject over an 8-week period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of ulcers | after 18 weeks | Sum of the number of days which the subject experienced ulcers over an 8-week period |
| Mean pain score | after 18 weeks | Mean pain scores (on the NRS\*) experienced during tooth brushing when ulcers were present \* NRS : numeric rating scale |
| Number of ulcers | after 18 weeks | Sum of the number of ulcers over an 8-week period |
Outcome results
None listed