Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis

Overview

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).

Full Title of Study: “Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis : a Randomised Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2010

Interventions

  • Other: sodium lauryl sulfate
    • 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.
  • Other: sodium lauryl sulfate
    • 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.
  • Other: sodium lauryl sulfate
    • 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.

Arms, Groups and Cohorts

  • Experimental: Group I
  • Active Comparator: Group II
  • Active Comparator: Group III

Clinical Trial Outcome Measures

Primary Measures

  • Number of episodes
    • Time Frame: after 18 weeks
    • Sum of the number of episodes experienced by the subject over an 8-week period

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yonsei University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shim Young Joo, research fellow – Yonsei University
  • Overall Official(s)
    • Jeong-Seung Kwon, Study Director, Yonsei University dental hospital

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