Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Recurrent Aphthous Stomatitis Mouth Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatitis Stomatitis, Aphthous Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Number of episodes

Time frame: after 18 weeks

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Dec 29, 2011
Registry last updated: Dec 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed