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Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shim Young Joo, Yonsei University
ClinicalTrials.gov Identifier:
NCT01501409
First received: December 23, 2011
Last updated: December 28, 2011
Last verified: December 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis : a Randomised Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Canker Sores
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Number of episodes [ Time Frame: after 18 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Sum of the number of ulcers over an 8-week period

  • duration of ulcers [ Time Frame: after 18 weeks ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501409

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

No publications provided

Responsible Party: Shim Young Joo, research fellow, Yonsei University
ClinicalTrials.gov Identifier: NCT01501409     History of Changes
Other Study ID Numbers: 2-2009-0012
Study First Received: December 23, 2011
Last Updated: December 28, 2011
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013