Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis

NCT01501409 | Completed DMC

• 1 other identifier: 2-2009-0012
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Recurrent Aphthous Stomatitis

Keywords

Sodium lauryl sulfate (SLS); recurrent aphthous stomatitis (RAS); dentifrice; pain

Outcome Measures

Primary Outcomes (1)

• Number of episodes

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

  after 18 weeks

Secondary Outcomes (3)

• Mean pain score

  after 18 weeks

• Number of ulcers

  after 18 weeks

• duration of ulcers

  after 18 weeks

Study Arms (3)

Group I

EXPERIMENTAL

Other: sodium lauryl sulfate

Group II

ACTIVE COMPARATOR

Other: sodium lauryl sulfate

Group III

ACTIVE COMPARATOR

Other: sodium lauryl sulfate

Interventions

sodium lauryl sulfate OTHER

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.

Group I

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The volunteers had a history of regularly recurring oral ulcerations of at least 6 months duration, with more than one episode per month

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Stomatitis, Aphthous; Pain

Interventions

Sodium Dodecyl Sulfate

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dodecanol; Fatty Alcohols; Alcohols; Organic Chemicals; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids

Study Officials

• Jeong-Seung Kwon

  Yonsei University dental hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research fellow

Study Record Dates

• First Submitted: December 23, 2011
• First Posted: December 29, 2011
• Study Start: January 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 29, 2011

Record last verified: 2011-12