Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis

Study Overview
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Brief Summary
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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).

Official Title
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Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis : a Randomised Clinical Trial

Conditions
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Recurrent Aphthous Stomatitis

Intervention / Treatment
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* Other: sodium lauryl sulfate
* Other: sodium lauryl sulfate
* Other: sodium lauryl sulfate


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br> | Other: sodium lauryl sulfate<br>* 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.<br>|
| Active Comparator: Group II<br> | Other: sodium lauryl sulfate<br>* The subjects were divided into three groups, each of which comprised 30 randomly assigned subjects: group II used SLS-A (a dentifrice containing 1.5%; Wiconi® dentifrice + 1.5% SLS) and SLS-B (a commercially available 1.5% SLS-containing dentifrice). 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.<br>|
| Active Comparator: Group III<br> | Other: sodium lauryl sulfate<br>* The subjects were divided into three groups, each of which comprised 30 randomly assigned subjects: group III used SLS-free (a commercially available SLS-free dentifrice (Wiconi® dentifrice), and SLS-B (a commercially available 1.5% SLS-containing dentifrice). 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes | Sum of the number of episodes experienced by the subject over an 8-week period | after 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score | Mean pain scores (on the NRS*) experienced during tooth brushing when ulcers were present * NRS : numeric rating scale | after 18 weeks | 
| Number of ulcers | Sum of the number of ulcers over an 8-week period | after 18 weeks | 
| duration of ulcers | Sum of the number of days which the subject experienced ulcers over an 8-week period | after 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sodium lauryl sulfate (SLS), recurrent aphthous stomatitis (RAS), dentifrice, pain