Recurrent Aphthous StomatitisNCT01501409
Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis
A study testing sodium lauryl sulfate in people with Recurrent Aphthous Stomatitis, run by Yonsei University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Aphthous Stomatitis
- What is being tested?
- sodium lauryl sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The volunteers had a history of regularly recurring oral ulcerations of at least 6 months duration, with more than one episode per month
Who cannot join
- 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
About this study
Official title: 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).
- Conditions
- Recurrent Aphthous Stomatitis
- Being tested
- sodium lauryl sulfate
- Keywords
- Sodium lauryl sulfate (SLS), recurrent aphthous stomatitis (RAS), dentifrice, pain
- Medical subject headings
- Stomatitis, Aphthous, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium lauryl sulfateOther
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 sulfateOther
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 sulfateOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Not described Receives: Other: sodium lauryl sulfate |
| Group II | Active comparator | Not described Receives: Other: sodium lauryl sulfate |
| Group III | Active comparator | Not described Receives: Other: sodium lauryl sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes
Sum of the number of episodes experienced by the subject over an 8-week period
Measured: after 18 weeks
Secondary outcomes (3)
Mean pain score
Mean pain scores (on the NRS*) experienced during tooth brushing when ulcers were present
- NRS : numeric rating scale
Measured: after 18 weeks
Number of ulcers
Sum of the number of ulcers over an 8-week period
Measured: after 18 weeks
duration of ulcers
Sum of the number of days which the subject experienced ulcers over an 8-week period
Measured: after 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Aphthous StomatitisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shim Young Joo, Yonsei University
- Investigators
- Jeong-Seung Kwon, Study director, Yonsei University dental hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501409
- Sponsor's protocol ID
- 2-2009-0012
- Status last verified
- Dec 2011
- First submitted
- 23 Dec 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Lauryl Sulfate on Recurrent Aphthous Stomatitis : a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01501409
- Acronym / sponsor ID
- 2-2009-0012
- Conditions
- Recurrent Aphthous Stomatitis
- Keywords
- Sodium lauryl sulfate (SLS), recurrent aphthous stomatitis (RAS), dentifrice, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: sodium lauryl sulfate |
| Group II | Active comparator | Other: sodium lauryl sulfate |
| Group III | Active comparator | Other: sodium lauryl sulfate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The volunteers had a history of regularly recurring oral ulcerations of at least 6 months duration, with more than one episode per month
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sodium lauryl sulfateThe 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. | Other | Group I |
| sodium lauryl sulfateThe 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. | Other | Group II |
| sodium lauryl sulfateThe 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. | Other | Group III |
Primary outcome
Number of episodes
Time frame: after 18 weeks
Sum of the number of episodes experienced by the subject over an 8-week period
3 secondary outcomes
Mean pain score
Time frame: after 18 weeks
Number of ulcers
Time frame: after 18 weeks
duration of ulcers
Time frame: after 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-Seung Kwon study director
Yonsei University dental hospital
Questions about this trial
What is this clinical trial studying?
A study testing sodium lauryl sulfate in people with Recurrent Aphthous Stomatitis, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of episodes (time frame: after 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2011.