- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01501409
Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis
December 28, 2011 updated by: Shim Young Joo, Yonsei University
Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis : a Randomised Clinical Trial
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I
|
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.
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.
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.
|
Active Comparator: Group II
|
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.
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.
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.
|
Active Comparator: Group III
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of episodes
Time Frame: after 18 weeks
|
Sum of the number of episodes experienced by the subject over an 8-week period
|
after 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
after 18 weeks
|
Number of ulcers
Time Frame: after 18 weeks
|
Sum of the number of ulcers over an 8-week period
|
after 18 weeks
|
duration of ulcers
Time Frame: after 18 weeks
|
Sum of the number of days which the subject experienced ulcers over an 8-week period
|
after 18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jeong-Seung Kwon, Yonsei University Dental Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 23, 2011
First Submitted That Met QC Criteria
December 28, 2011
First Posted (Estimate)
December 29, 2011
Study Record Updates
Last Update Posted (Estimate)
December 29, 2011
Last Update Submitted That Met QC Criteria
December 28, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-2009-0012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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