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Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501409
First Posted: December 29, 2011
Last Update Posted: December 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shim Young Joo, Yonsei University
  Purpose
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).

Condition Intervention
Recurrent Aphthous Stomatitis Other: sodium lauryl sulfate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis : a Randomised Clinical Trial

Resource links provided by NLM:


Further study details as provided by Shim Young Joo, Yonsei University:

Primary Outcome 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 Outcome 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


Enrollment: 90
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I 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.
Active Comparator: Group II 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.
Active Comparator: Group III 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501409


Sponsors and Collaborators
Yonsei University
Investigators
Study Director: Jeong-Seung Kwon Yonsei University dental hospital
  More Information

Responsible Party: Shim Young Joo, research fellow, Yonsei University
ClinicalTrials.gov Identifier: NCT01501409     History of Changes
Other Study ID Numbers: 2-2009-0012
First Submitted: December 23, 2011
First Posted: December 29, 2011
Last Update Posted: December 29, 2011
Last Verified: December 2011

Keywords provided by Shim Young Joo, Yonsei University:
Sodium lauryl sulfate (SLS)
recurrent aphthous stomatitis (RAS)
dentifrice
pain

Additional relevant MeSH terms:
Stomatitis
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases