Oral Diseases (2012) doi:10.1111/j.1601-0825.2012.01920.
x
ORIGINAL ARTICLE
Effect of sodium lauryl sulfate on recurrent aphthous
stomatitis: a randomized controlled clinical trial
YJ Shim, J-H Choi, H-J Ahn, J-S Kwon
TMJ and Orofacial Pain Clinic, Department of Oral Diagnosis & Oral Medicine, College of Dentistry, Yonsei University, Seoul,
Korea
OBJECTIVE: To compare the effects of sodium lauryl
sulfate (SLS)-free and SLS-containing dentifrice in patient
with recurrent aphthous stomatitis (RAS).
MATERIALS AND METHODS: The design of this study
was a double-blind crossover trial. The 90 subjects were
divided into three groups: group I used SLS-free (a
commercially available SLS-free dentifrice) and SLS-A
(SLS-free + 1.5% SLS), group II used SLS-A and SLS-B
(a commercially available 1.5% SLS-containing denti-
frice), and group III used SLS-free and SLS-B. 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 ran-
dom, and there was a 2-week washout period between
the two phases. The clinical parameters (number of
ulcers, number of episodes, duration of ulcers, mean
pain score) were compared between the two phases for
each group.
RESULTS: The number of ulcers and episodes did not
differ significantly between SLS-A, SLS-B, and SLS-free.
Only duration of ulcers and mean pain score was signifi-
cantly decreased during the period using SLS-free.
CONCLUSION: Although SLS-free did not reduce the
number of ulcers and episodes, it affected the ulcer-
healing process and reduces pain in daily lives in patients
with RAS.
Oral Diseases (2012) doi: 10.1111/j.1601-0825.2012.01920.x
Keywords: sodium lauryl sulfate; recurrent aphthous stomatitis;
dentifrice; pain
Correspondence: Jeong-Seung Kwon, DDS, MSD, Clinical Assistant
Professor, TMJ and Orofacial Pain Clinic, Department of Oral
Diagnosis & Oral Medicine, College of Dentistry, Yonsei University,
134 Shinchon-dong, Seodaemun-gu, Seoul 120-752, Korea. Tel:
82 2 2228 3111, 82 2 2228 8880, Fax: 82 2 393 5673, E-mail: jskwon@
yuhs.ac
Received 28 December 2011; revised 2 February 2012; accepted 15
February 2012
 2012 John Wiley & Sons A/S
All rights reserved
www.wiley.com
Introduction
Recurrent aphthous stomatitis (RAS) is a painful,
recurring condition in which solitary or multiple ulcer-
ations form on the non-keratinized oral mucosa. RAS
affects at least 10% of the population, with a slight
female predilection. The ulcers have well-circumscribed
margins, erythematous haloes, and yellow or gray floors.
They appear first in childhood or adolescence, and heal
naturally in 7–14 days (Scully, 2008). RAS is usually
painful and can lead to difficulty in eating, speaking,
laughing, and toothbrushing, and influcencing on daliy
life (Krisdapong et al, 2012). Hapa et al (2012) stated
that patients with RAS who had more than six episodes
in 1 year had a poorer quality of life compared with
controls.
The etiology of RAS is unknown, but local and
systemic contributing factors have been reported. Sys-
temic factors are a genetic predisposition, psychological
stress, menstrual cycle, immune dysregulation, and
nutritional deficiencies, and deficiencies in hematinic
factors such as iron, folic acid (folate), and vitamin B.
Local factors include sodium lauryl sulfate (SLS) in
dentifrice, trauma of the oral tissues, smoking, infection,
and hypersensitivities to food items such as gluten, whole
wheat, chocolate, nuts, shell-fish, soy, and cheese. These
are thought to be the predisposing factors of chronic
aphthous stomatitis (Olga and Joan, 1992). Scully and
Porter (1989) suggested that RAS is attributable to a
hypersensitive host response to exogenous bacterial,
viral, or dietary antigens that penetrate the oral mucosa.
Sodium lauryl sulfate is an anionic detergent that has
been used as the major or sole surfactant in most
dentifrice agents for more than 20 years. It solubilizes
flavor oils and lipid-soluble anti-bacterial agents in
dentifrice (Waaler et al, 1993), and it exerts a direct anti-
microbial effect (Giertsen et al, 1989; Wade and Addy,
1992; Waaler et al, 1993). It also reduces the surface
tension and enhances foaming action (Wilkins, 1994).
As it aids in spreading the dentifrice throughout the
mouth, it creates the impression of cleanliness, and a
mouthful of foam Ôjust feels cleaner’.
 Sodium lauryl sulfate and aphthous stomatitis
YJ Shim et al
2
However, SLS may also induce adverse effects. It is
well known that SLS is an irritant to skin at high
concentrations and that its repeated application results
in a dose-dependent contact dermatitis (van der Valk
et al, 1984; Willis et al, 1989). Siegel and Gordon (1985,
1986) found that SLS reduces the protective barrier
function of the oral epithelium. Widening of the stratum
corneum because of separation and loss of surface
epithelial layers by SLS has also been observed in an
experimental model (Herlofson and Barkvoll, 1994).
Jacoby et al (1975)) stated that dentifrice surfactants are
responsible for a reduction in the keratinization index of
the human oral epithelium, probably due to rupture of
the intercellular junctions. SLS may have an affinity for
proteins and may cause denaturation (Tzutzumi et al,
1982). In addition, oral epithelial sloughing, ulcerations,
and inflammation caused by SLS have been observed
(Rubright et al, 1978; Searls and Berg, 1986; Herlofson
and Barkvoll, 1993). Eva and Torstein found that the
sensitivity to low concentrations of SLS was much
higher for the oral mucosa than for the skin in animal
models (Ahlfors and Lyberg, 2001). Researchers have
shown that SLS dries out the protective mucous layer
lining of the mouth, leaving the gingival and buccal
mucosa vulnerable to irritants (Barkvoll and Rolla,
1989).
The results of some studies suggest that SLS is a
predisposing factor of RAS. Barkvoll and Rolla (1991)
reported a possible association between the usage of
SLS-containing dentifrice and RAS. They reported that
the mean ulcer incidence in a group of 10 RAS patients
during a 3-month experiment period was 71.5% lower
when using SLS-free dentifrice than when using SLS-
containing toothpaste (Healy et al, 1999). Chahine et al
(1997) found that the incidence of RAS among 23
volunteers was 81% lower when they were using SLS-
free dentifrice than when they were using SLS-contain-
ing dentifrice.
Herlofson and Barkvoll (1994) reported that 10
patients using SLS-free dentifrice exhibited a 70%
reduction in the number of ulcers compared to the
prestudy period involving the use their regular denti-
frice, and a 60% reduction compared with patients who
used a 1.2%-SLS-containing dentifrice.
On the other hand, in a double-blind crossover
clinical trial by Healy et al (1999), the measured ulcer
parameters (number of ulcer days, total pain scores,
number of ulcer episodes, and number of ulcers) did not
differ significantly between the use of SLS-free and SLS-
containing dentifrice.
Some studies found that the incidence or number of
ulcers was significantly lower when using SLS-free
dentifrice than when using SLS-containing dentifrice,
but others have found no such significant differences.
These discrepancies have led to considerable contro-
versy over the effect of SLS on RAS, but we hypoth-
esized that SLS is a local irritant to RAS.
The aim of this study was to compare the effects of
SLS-free and SLS-containing dentifrice in a population
of patients suffering from RAS. With the exception of
Healy’s work, previous studies have evaluated only a
Oral Diseases
single clinical parameter (e.g., the number of ulcers or
the incidence of ulcers) with only one control, using
the single-blind crossover design. In contrast, this
study compared the number of ulcers, frequency of
recurrence, duration of ulcers, and presence of pain
during tooth brushing in a double-blind crossover trial.
Furthermore, we used two control dentifrices to
establish whether dentifrice ingredients other than
SLS affect RAS.
Materials and methods
Subjects
The subjects included in this study were recruited by
posting a notice on a bulletin board for RAS sufferers
in the Yonsei University health system (medical and
dental hospital) and Yonsei University, college of
dentistry, or by referral from the department of oral
diagnosis and oral medicine, Yonsei University dental
hospital, from January 2010 to August 2010. The
volunteers had a history of regularly recurring oral
ulcerations of at least 6 months duration, with more
than one episode per month. The following exclusion
criteria were applied: already using an SLS-free den-
tifrice, taking medications affecting oral ulcers (e.g.,
corticosteroids), having chronic oral mucosal disease
(ex, lichen planus, pemphigus vulgaris, pemphigoid,
etc.), having allergies to food or medications, and
being pregnant.
Each volunteer was interviewed by a clinician, who
documented his or her age, gender, medical history, and
drug history at the first visit. The clinician provided
detailed information about the study to the volunteers,
after which informed consent to participate was
obtained from all subjects prior to the commencement
of the study. The subjects were instructed not to change
their oral hygiene habits, eating habits, or lifestyle
during the study. They were requested not to take any
other treatment or medication to heal or relieve the oral
ulcers during the entire study period.
Dentifrices and toothbrushes
The subjects were asked to brush their teeth using their
usual toothbrushing method with the dentifrice and
toothbrush supplied. Three dentifrices were used for this
study: (i) a commercially available SLS-free dentifrice
(SLS-free; Wiconi dentifrice, Seoul, Korea), (ii) a
dentifrice containing 1.5% SLS (SLS-A; Wiconi den-
tifrice + 1.5% SLS), and (iii) a commercially available
1.5% SLS-containing dentifrice (SLS-B). All dentifrices
were packed in the same plain white tubes and labeled
with the identification number of the subject. Both the
clinicians and subjects were blind as to the type of
dentifrice being used. The main components of the three
dentifrices are presented in Table 1.
Study design
The design of this study was a double-blind crossover
trial that was undertaken with the approval of Institu-
tional Review Board of the Yonsei University Dental
Hospital (IRB number: 2-2009-0012). The subjects were
 Sodium lauryl sulfate and aphthous stomatitis
YJ Shim et al

3
Table 1 Main components of dentifrices
SLS-free SLS-A SLS-B

Abrasives Silicon dioxide Silicon dioxide Silicon dioxide precipitated

calcium carbonate
Humectants D-sorbitol syrup D-sorbitol syrup D-sorbitol syrup ⁄ glycerin
Sweeting agents Xylitol Xylitol Sodium saccharin
Additional agent Proplolis Proplolis Proplolis ⁄ ginseng extract
Flavoring agent Phytoncide oil ⁄ Phytoncide oil ⁄ DL-menthol sodium
spearmint oil spearmint oil benzoate
Surfactants Not contained 1.5% SLS 1.5% SLS

SLS, sodium lauryl sulfate.

divided into three groups, each of which comprised 30 Results

randomly assigned subjects: group I used SLS-free and
SLS-A, group II used SLS-A and SLS-B, and group III
used SLS-free and SLS-B. 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 clinical parameters of the subjects were compared
between the two phases for each group and are
presented in Table 2.
Ulcer diaries
The subjects were asked to keep a diary to record the
presence of ulcers during the study period (see Appendix
A). When ulcers developed, subjects recorded the first
and last days of each episode, the number of ulcers, and
the pain score during tooth brushing. The pain score
was rated on a scale of 0–10, where 0 represents Ôno
pain’ and 10 represents Ôthe worst pain ever experienced’
(numeric rating scale).
After each phase, the subjects visited us and brought
their diaries. We checked the diaries, examined the oral
cavity, and asked about any discomfort related to the
dentifrices.
Subject demographics
Sixty of the 90 volunteers completed the study. The high
dropout rate was because of many of the subjects
experiencing unbearable pain during the experimental
period that resulted in them wanting to take medications
to relieve the symptoms: seven from group I (n = 23
completed the study), 12 from group II (n = 18
completed the study), and 11 from group III (n = 19
completed the study). From the viewpoint of dentifrice
type, five from during the period using SLS-free, 13
from during the period using SLS-A, and 12 from
during the period using SLS-B. From the viewpoint of
dropout time, 14 from the first 8 weeks and 16 from the
second 8 weeks. The demographic characteristics of the
subjects according to group are listed in Table 3.
Group I results
Data for the parameters in the group I are given in
Table 4. The duration of ulcers and mean pain score
were significantly decreased during the period using
SLS-free compared to that using SLS-A (P < 0.05).
The number of ulcers or the number of episodes did not
differ significantly between these periods. There was no
reported discomfort associated with any of the denti-
frices.

Statistical analysis Table 3 Demographic characteristics of the subjects

The differences in clinical parameters between the two
phases were analyzed by non-parametric Wilcoxon Group I Group II Group III
signed-rank test. SPSS Version 12.0 statistical package (n = 23) (n = 18) (n = 19)
(SPSS Inc., Chicago, IL, USA) was used for all
statistical analyses. P values <0.05 were considered to Agea 41.13 ± 15.66 44.22 ± 11.70 45.89 ± 8.49
Male 8 (34.8%) 9 (50%) 10 (52.6%)
be statistically significant. Female 15 (65.2%) 9 (50%) 9 (47.4%)

a
Values are given as mean ± standard deviation (s.d.).
Table 2 Clinical parameters

Parameter Explanation Table 4 Group I results

Number of Sum of the number of ulcers over an 8-week period Parameters SLS-free SLS-A P-value*
ulcers
Number of Sum of the number of episodes experienced by the Number of ulcersa 4 (0–20) 4 (0–20) 0.066
episodes subject over an 8-week period Number of episodesa 3 (0–8) 3 (2–8) 0.138
Duration of Sum of the number of days which the subject Duration of ulcersa 17 (0–46) 21 (7–52) 0.038*
ulcers experienced ulcers over an 8-week period Mean pain scorea 2 (0–7) 4 (0–8) <0.0001*
Mean pain Mean pain scores (on the NRS) experienced during
score tooth brushing when ulcers were present SLS, sodium lauryl sulfate.
*P value was considered significant when < 0.05.
a
NRS, numeric rating scale. Values are given as median (minimum–maximum).

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 Sodium lauryl sulfate and aphthous stomatitis
YJ Shim et al

4
Table 5 Group II results SLS in dentifrice causes enhanced penetration of
exogenous antigens. This raises the possibility that
Parameters SLS-A SLS-B P-value* SLS plays a role in the pathogenesis of RAS (Healy
et al, 1999).
Number of ulcersa 4 (0–11) 5.5 (0–12) 0.289
Number of episodesa 3 (0–7) 3 (0–9) 0.159
Duration of ulcersa 14.5 (0–51) 22 (0–47) 0.069 Main findings
Mean pain scorea 3.5 (0–8) 5 (0–8) 0.237 In group I, the duration of ulcers was significantly shorter
during the period using SLS-free compared to that using
SLS, sodium lauryl sulfate. SLS-A. The numbers of ulcers and episodes did not differ
*P value was considered significant when < 0.05.
a
Values are given as median (minimum–maximum). significantly. Although SLS-free did not reduce the num-
bers of ulcers and episodes, it affected to ulcer-healing
process and it took a short time for the ulcer to heal.
Table 6 Group III results In group III, the number of episodes and duration of
ulcers were significantly decreased during the period
Parameters SLS-free SLS-B P-value* using SLS-free compared to that using SLS-B.
a
In group II, we compared SLS-A and SLS-B to
Number of ulcers 4 (1–12) 5 (2–13) 0.112
Number of episodesa 3 (1–9) 4 (2–11) 0.022*
determine whether other ingredients in the compounds
Duration of ulcersa 15 (4–44) 21 (8–33) 0.026* of SLS-free dentifrice affect the healing process of
Mean pain scorea 1 (0–8) 3 (1–8) 0.001* ulceration. None of the clinical parameters (including
the healing time) differed significantly between the two
SLS, sodium lauryl sulfate. SLS-containing dentifrices.
*P value was considered significant when < 0.05. Some results were contrary to what we expected.
a
Values are given as median (minimum–maximum).
Some subjects had more ulcer periods when they were
using SLS-free, while others using SLS-A or SLS-B had
Group II results fewer ulcer periods. SLS is an effective anti-plaque and
Data for the parameters in the group II are given in antimicrobial agent. The direct antimicrobial effect has
Table 5. The number of ulcers, number of episodes, been attributed to the adsorption of SLS on to bacterial
duration of ulcers, and mean pain score all tended to cell walls (thus interfering with cell-wall integrity),
decrease during the period using SLS-A compared to inhibition of bacterial enzymes involved in glucose
that using SLS-B were decreased, but the differences metabolism, and competition for tooth binding sites. It
were not statistically significant. There were no reported is possible that this anti-plaque action helps to reduce
discomforts associated with any of the dentifrices. secondary bacterial infection of ulcerations. Loss of this
action may mask any benefit of a reduced irritant effect
Group III results with the use of SLS-free dentifrice in RAS patients. In
Data for the parameters in the group III are given in addition, we may not have controlled for all local and
Table 6. The number of episodes, duration of ulcers, systemic predisposing and precipitating factors of RAS.
and mean pain score were significantly decreased during Therefore, the apparently contradictory effects may
the period using SLS-free compared to that using SLS-B simply be the result of natural fluctuation of the disease.
(P < 0.05). However, the number of ulcers did not The results of the study are very similar to those of the
differ significantly. There were no reported discomforts only other double-blind randomized controlled trial
associated with any of the dentifrices. performed by Healy et al (1999). In Healy’s study, none
of the ulcer parameters (number of ulcer episodes,
number of ulcer days, number of ulcers, and the total
Discussion
pain scores) was differed significantly between the phase
The oral epithelium is considered to be an important using 1.5% SLS-containing and SLS-free dentifrice.
physiologic barrier to the passage of potentially harmful Similarly, in this study, the number of ulcers and
substances through to the underlying connective tissue. episodes did not differ significantly. So we concluded
Thus, the integrity of this barrier is important to the that SLS-free dentifrice had no effect on the occurrence
organism impairment if the ability of this barrier to of RAS. But in this study, the duration of ulcers and
perform its function could be harmful (Siegel and mean pain score were significantly decreased during the
Gordon, 1986). period using SLS-free compared to SLS-A and SLS-B.
Sodium lauryl sulfate may damage the mucin layer The subjects felt less pain and it took lesser time for the
by denaturing its glycoproteins. Mucin is the principal ulcer to heal during the period using SLS-free. Although
organic constituent of mucus, the visco-elastic material it is difficult to explain the different result from Healy’s
that covers all mucosal surfaces, and plays an essential study, one possible explanation is the difference of
role in the non-immune protection of the mucosal dentifrice used in the study. Other ingredients, except
surfaces (Tabak et al, 1982). The denaturing effect of SLS in dentifrice used in Healy’s study, may stimulate
SLS on the mucin layer with exposure of the under- the healing process of ulcers, and offset delayed healing
lying epithelium is believed to increase the incidence of by SLS. Another possible explanation is the difference
RAS (Herlofson and Barkvoll, 1994). It is possible that of dentifrice used in washout period. The subjects used
impairment of the barrier function of oral mucosa by the same dentifrice (SLS-free dentifrice) as in the

Oral Diseases

subsequent (SLS-free) phase in Healy’s study, but the
same dentifrice (SLS-containing dentifrice) as they used
before participating in our study. So, subjects in our
study may feel lesser pain by using SLS-free dentifrice
because they use it after using SLS-containing dentifrice.
The other possible explanation is that the participated
subjects in the two studies were different in race, the
kinds of food they eat daily, the culture, and so on.
Response to external stimuli and pain expression may be
different. For example, Koreans eat more hot and spicy
food. It may affect the healing process of ulcers. It may
also sensitize to external stimulus such as SLS. Those
things may cause different results.
Differing from the Healy’s study, we set up two
control SLS-containing dentifrice groups to determine
whether other ingredients of SLS-free affect the healing
process of ulceration. SLS-free contained phytoncide
oil, known to be natural antibiotics, and we expected
that the SLS-A may also help the healing process of
RAS. But, none of the clinical parameters (including the
healing time) differed significantly between SLS-A and
SLS-B. It is possible that SLS may delay the healing
process of RAS.
We found some interesting results. To evaluate the
effect of SLS between subjects who experience ulcers
frequently and those who experience ulcers infrequently,
we selected group I (because group I was same design of
Healy’s study) according to the duration of ulcers. Our
reference point was 15 days because most minor apht-
hous ulcers heal naturally in a week or two. In the
infrequent group (Ulcer durations of £15 days, n = 11,
mean = 5), all clinical parameters were significantly
decreased during the period using SLS-free dentifrice.
However, in the frequent group (Ulcer durations of >15
days, n = 12, mean = 23.5), only the mean pain score
during tooth brushing was significantly decreased during
the period using SLS-free dentifrice. In Healy’s study,
the mean number of ulcer days was 22.7 for SLS paste
and 20.4 for SLS-free paste. Applying our reference
point to that study, they experienced ulcers frequently.
The number of ulcer days did not differ significantly.
Such result corresponded with our analysis. SLS is a
local factor that damages the mucous protective layers
of the mouth. Using SLS-free dentifrice was beneficial to
infrequent RAS sufferers in terms of the incidence of
RAS, but in frequent RAS sufferers, controlling the
local factors such as SLS did not decrease the number of
ulcers, number of episodes, or duration of ulcers. It is
therefore thought that frequent RAS sufferers may be
more affected by systemic factors, such as the host’s
immune system, rather than local factors that affect
RAS. But further investigation with a larger sample size
is needed, because the sample size of frequent and
infrequent group in our study was small.
However, in all groups, the mean pain score was
significantly decreased during the period using SLS-free
dentifrice compared to during the period using SLS-
containing dentifrice. We can know that indirectly from
the period that the subjects gave up this trial. Among 30
dropped out subjects, five from during the period using
SLS-free and 25 from during the period using SLS-
Sodium lauryl sulfate and aphthous stomatitis
YJ Shim et al
5
containing dentifrice (SLS-A and SLS-B). Because the
subjects should not take medication during the clinical
trial, they gave up because of unbearable pain. There
was no difference between the dropout rate of the first
8 weeks and the second 8 weeks. So, we suggested that
dropout rate increased more owing to pain by use of
SLS-containing dentifrice rather than by ulcer itself.
Pain during tooth brushing or eating is the main reason
why patients with RAS consult a doctor. Through
reduced pain during tooth brushing, RAS sufferers
brush their teeth considerably better than before. This
helps to reduce secondary bacterial infection of ulcer-
ations and plays a role in the ulcer-healing process.
Therefore, SLS-free dentifrice will be beneficial to RAS
sufferers by reducing pain in their daily lives and
improve the quality of life.
Limitations
While we found that SLS could delay the healing
process of ulcerations (SLS-free dentifrice shortened the
duration of ulcers), this study was subject to some
limitations.
First, there was no prestudy evaluation period, in that
we only compared periods using SLS-free and SLS-
containing dentifrice.
Second, many local and systemic factors are involved
in the pathogenesis of RAS, and as such there are many
variables to control, which make it even more difficult
for researchers to identify the underlying mechanisms.
Third, the keeping of a diary is an inaccurate way to
record subjective symptoms. We did not record the size
of the ulcers because it is both difficult and bothersome
for subjects to visit a clinician whenever ulcers develop.
Finally, the cohort was small and it had a high
dropout rate because of many of the initially recruited
volunteers experiencing unbearable pain during the
ulcer period, which made it very difficult for them to
consume any food and meant that they wanted to take
medication or to be treated.
Future studies could perform a more precise analysis
by adopting the following approaches:
1 Dividing subjects according to the frequency of
ulceration on the basis of a prestudy evaluation
period.
2 Controlling for age, gender, and number of sub-
jects between any two experimental groups.
3 Controlling for variables such as hematinic defi-
ciencies, trauma, changes in the routines of daily
life, and stressful events.
4 Developing a more accurate recording system that
the patients can easily use.
5 Using a larger cohort
Conclusion
In conclusion, we found that the numbers of ulcers and
episodes did not differ significantly during the period
using SLS-free dentifrice. But the duration of ulcers and
mean pain score were different significantly during the
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 Sodium lauryl sulfate and aphthous stomatitis
YJ Shim et al

6
period using SLS-free dentifrice. Although SLS-free Searls JC, Berg CA (1986). The influence of dentifrice detergents
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lesser time for the ulcer to heal. SLS-free dentifrice will permeability of rat oral mucosa to non-electrolytes in vivo.
Arch Oral Biol 30: 43–47.
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Siegel IA, Gordon HP (1986). Surfactant-induced alterations
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Young Joo Shim designed study, analysed data and drafted the Tzutzumi M, Oyama Y, Suda I, Watanabe T (1982). Action of
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