Clinical Trial: Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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).

Detailed Summary:
Sponsor: Yonsei University

Current Primary Outcome: Number of episodes [ Time Frame: after 18 weeks ]

Sum of the number of episodes experienced by the subject over an 8-week period


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Yonsei University

Dates:
Date Received: December 23, 2011
Date Started: January 2010
Date Completion:
Last Updated: December 28, 2011
Last Verified: December 2011