Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis

Recurrent Aphthous Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501409
• Other study ID #: 2-2009-0012
• Status: Completed
• Phase: N/A
• First received: December 23, 2011
• Last updated: December 28, 2011
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Recurrent Aphthous Stomatitis
• Stomatitis
• Stomatitis, Aphthous

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes	Sum of the number of episodes experienced by the subject over an 8-week period	after 18 weeks	No
Secondary	Mean pain score	Mean pain scores (on the NRS*) experienced during tooth brushing when ulcers were present; * NRS : numeric rating scale	after 18 weeks	No
Secondary	Number of ulcers	Sum of the number of ulcers over an 8-week period	after 18 weeks	No
Secondary	duration of ulcers	Sum of the number of days which the subject experienced ulcers over an 8-week period	after 18 weeks	No