Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis
Not Applicable
Completed
- Conditions
- Recurrent Aphthous Stomatitis
- Interventions
- Other: sodium lauryl sulfate
- Registration Number
- NCT01501409
- Lead Sponsor
- Yonsei University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group I sodium lauryl sulfate - Group III sodium lauryl sulfate - Group II sodium lauryl sulfate -
- Primary Outcome Measures
Name Time Method Number of episodes after 18 weeks Sum of the number of episodes experienced by the subject over an 8-week period
- Secondary Outcome Measures
Name Time Method Mean pain score after 18 weeks Mean pain scores (on the NRS\*) experienced during tooth brushing when ulcers were present
\* NRS : numeric rating scaleNumber of ulcers after 18 weeks Sum of the number of ulcers over an 8-week period
duration of ulcers after 18 weeks Sum of the number of days which the subject experienced ulcers over an 8-week period