ORIGINAL ARTICLE

A Azaripour Effectiveness of a miswak

B Mahmoodi
E Habibi extract-containing toothpaste on
I Willershausen gingival inflammation: a randomized
I Schmidtmann
B Willershausen clinical trial

Authors’ affiliations:
A Azaripour, B Mahmoodi, E Habibi,
I Willershausen, B Willershausen, Department
of Operative Dentistry and Periodontology,
University Medical Centre, Johannes
Gutenberg University, Mainz, Germany
I Schmidtmann, Institute of Medical Bio-
statistics, Epidemiology and Informatics,
University Medical Centre, Johannes
Gutenberg University, Mainz, Germany
Correspondence to:
Dr Adriano Azaripour
Department of Operative Dentistry
University Medical Center of the Johannes
Gutenberg University
Augustusplatz 2
D-55131 Mainz, Germany
Tel.: +49 6131 177246
Fax: +49 6131 173406
E-mail: adrianoasso@hotmail.com
Abstract: Objectives: In this study, the efficacy of a miswak extract-
containing toothpaste (Salvadora persica) on gingival inflammation
was compared with that of a herbal and a conventional toothpaste.
Methods: Non-smoking outpatients with sulcus bleeding index (SBI)
≥25% and with periodontal pocket depths ≤3 mm were randomly
selected and divided into three groups: M-group, miswak extract-
containing toothpaste; P-group, herbal toothpaste; and C-group,
conventional toothpaste. After instructing the patients to brush their
teeth twice a day for 3 weeks with the assigned toothpaste using a
flat-trimmed manual toothbrush, a thorough oral examination was
performed by a calibrated examiner (EH). The primary outcome was
the SBI after 21 days. Furthermore, the amount of plaque was
measured by approximal plaque index (API). Results: Sixty-six
patients with a mean age of 57.8  10.2 years were recruited and
enrolled. After 3 weeks of brushing, all three patient groups showed a
significant reduction in SBI. The P-group (SBI reduction: 17.1%  9.1)
and the M-group (14.5%  8.1) showed the strongest effect followed
by the C-group (9.4%  7.8). All three groups showed a significant
reduction in API without significant differences between the groups.
Conclusions: The use of each of the three tested toothpastes caused
a significant reduction in gingival inflammation and amount of plaque.
The miswak extract-containing toothpaste showed a similar effect as
the herbal toothpaste and can be safely used for domestic oral
hygiene in patients with gingivitis.

Key words: gingival inflammation; herbal dentifrice; miswak;

toothpaste

Introduction
Dates:
The removal of dental plaque and food debris is necessary to maintain
Accepted 30 November 2015
oral health and plays an important role in the prevention of caries and
To cite this article:
periodontal diseases. Oral hygiene has been practiced by different cul-
Int J Dent Hygiene tures for thousands of years. The chewing stick or miswak (meswak or
DOI: 10.1111/idh.12195 siwak) which originates from trees of the family Salvadoraceae (Salvadora
Azaripour A, Mahmoodi B, Habibi E, persica) is the first known tooth-cleaning tool in history, and its use dates
Willershausen I, Schmidtmann I, Willershausen B. back as early as 3500 BC (1). It has been used by Persian, Greek and
Effectiveness of a miswak extract-containing Roman empires and by Egyptians, Jews and Japanese (2). Presently,
toothpaste on gingival inflammation: a randomized chewing sticks are mainly used in Asia, Africa, South America and espe-
clinical trial. cially in Islamic countries where its use is sanctioned as a religious prac-
© 2015 John Wiley & Sons A/S. Published by tice (3–6). Chewing sticks can play an important role in tooth cleaning,
John Wiley & Sons Ltd especially in developing countries, and are therefore recommended by

Int J Dent Hygiene | 1

Azaripour et al. Miswak toothpaste and gingival inflammation
Oral Hygiene Working Groups as an effective tool for oral
hygiene in areas where their use is customary (7).
During the past decades, alternative medical treatment
concepts have received attention especially among Western
cultures. These concepts led to the development and market-
ing of oral health products with natural ingredients. There is
a variety of dental products promoted as alternatives to the
established oral hygiene products containing natural and her-
bal ingredients. Recently, dentifrices with miswak extracts
have become commercially available (8). The extract consist
of essential ingredients for caries prevention such as fluorides,
silicate, potassium sulphate, calcium sulphate, tannins, sapo-
nins, vitamin C and chlorides (9). Recently, several studies
have reported an antibacterial effect of miswak extracts.
Almas et al. showed in 2002 that the application of miswak
extracts effectively removed smear layers from the root sur-
face (10). The study of Al lafi et al. reported an antibacterial
effect of miswak sticks against aerobic and anaerobic oral
bacteria (11). In an in vitro study in 2008, Sofrata et al. made
the observation that miswak had powerful inhibitory effects
on the growth of Porphyromonas gingivalis and Aggregatibacter
actinomycetemcomitans (12). The use of a mouthwash contain-
ing miswak extract showed antimicrobial activity (13). In a
clinical study, a miswak-containing mouthwash improved gin-
gival health and lowered the carriage rate of cariogenic bacte-
ria (14). Moreover, miswak extracts are effective against
various types of oral bacteria implicated in caries or periodon-
tal disease (11–14).
The aim of this clinical study was to compare the efficacy of
a miswak extract-containing toothpaste to treat gingival inflam-
mation with that of two other toothpastes. Because herbal com-
ponents are essential ingredients of miswak, a herbal
toothpaste (Parodontax) was selected for comparison besides
Colgate that is a well-documented and effective conventional
toothpaste and is recommended for oral hygiene.
Study population and methodology
Experimental design
A randomized 3-week prospective clinical trial with three par-
allel groups was designed.
Study population
Outpatients of the Department of Operative Dentistry were
screened at the University Medical Center (Mainz, Germany)
in the period of February–April 2014. Patients who met the
inclusion and exclusion criteria were recruited for enrolment.
Inclusion criteria
• ≥18 years old;
• Willing to participate and willing to sign the informed
consent;
• Having SBI ≥25% (15);
• No pocket depths >3 mm;
2 | Int J Dent Hygiene
• At least 20 teeth (with five teeth in each quadrant);
Systemically healthy.
Exclusion criteria
• Known hypersensitivity to ingredients of toothpastes used
in this study;
• Caries cavities next to the marginal gingiva that could
cause gingival bleeding;
• Antibiotic therapy <3 months before treatment;
• Smoker;
• Pregnancy or wish for pregnancy;
• Participation in another clinical study;
• Not being able to participate in the screening appointments.
Interventions
Screening visit
After a careful medical health evaluation (including dental
assessment), a thorough dental assessment was performed,
which included an orthopantomogram to determine caries
frequency as well as the periodontal situation. When
patients were considered eligible for the research project,
they were further assessed and checked on the basis of the
inclusion/exclusion criteria. The patients were informed
about the aim and details of the study. The participants
signed the informed consent form when they accepted to
participate voluntary in the clinical trial. Furthermore, the
participants were informed to refrain from any other oral
hygiene procedures (mouthwashes, etc.) during the period of
the study.
Baseline visit
Each participant received an individual trial number. Random-
ization was performed using random numbers from a com-
puter-generated list (Microsoft Excel 2011). Following the
recruitment, the patients were randomly allocated to one of
the following groups:
1 M-group (using miswak-containing toothpaste; Miswak Nat-
urelle LLC, Dubai, UAE),
2 P-group (using a herbal toothpaste; Parodontax,
GlaxoSmithKline, B€ uhl, Germany) and
3 C-group (using a conventional toothpaste; Colgate Total
original, Colgate-Palmolive, Hamburg, Germany)
The ingredients of the dentifrices are shown in Table 1.
All patients received a new flat-trimmed manual toothbrush
(Sensodyne; GlaxoSmithkline) and were instructed to brush
their teeth twice a day for 2 min over a period of 21 days. Fur-
thermore, patients were instructed to use exclusively the
assigned toothpaste and to report any irritation of gingiva, bad
taste or other side effects.
To check the compliance, the subjects had to make a note
of the date and the time they brushed their teeth.

Table 1. Ingredients of the tested dentifrices
Dentifrices tested in the clinical study
Name Batch number Manufacturer
Miswak NL 2609 Naturelle LLC, Dubai, UAE
Parodontax 327OBK WB GlaxoSmithKline Consumer
€ hl, Germany
Healthcare, Bu
Colgate Total CP(L) 4204PL1121 Colgate-Palmolive, Hamburg,
original Germany
Oral assessment
Baseline visit
The oral assessments were performed by a calibrated examiner
(EH) and included periodontal parameters such as SBI (15)
and API (15) (Appendix 1) using plaque-disclosing tablets (PD
Produits Dentaires SA, Vevey, Switzerland) for 30 s and subse-
quent rinsing with water. Third molars were excluded from
the measurements and examination.
Modified SBI and API according to Lange et al. (15)
The dichotomous index (yes/no decision) regards the bleeding
in the interdental spaces after probing with a periodontal
probe. In the first quadrant, the spaces are checked from the
lingual/palatal side and in the second quadrant from the buccal
side. The third quadrant is probed from the lingual side and
the fourth from the buccal side again. In total, a maximum of
28 measuring sites can be achieved. Similar to the modified
SBI, the API dichotomous index regards the interdental spaces
alternating from the buccal or the lingual/palatal surfaces as
described above. It evaluates interdental plaque accumulation.
For this purpose, plaque is stained with plaque-disclosing
tablets, and afterwards, the (maximum of 28) interdental
spaces are scored quadrant-wise.
These indices are calculated as follows:
P
positive scored sites  100
P
all available sites
Reevaluation after 21 days
At the end of the study after 21 days, the same examiner
(EH) performed a second dental assessment. The re-evalua-
tion was performed in the morning and patients were not
allowed to do any oral hygiene procedures (tooth brushing,
mouth rinsing, etc.) to avoid any gingival irritation through
tooth brushing before the oral examination. In this way,
Azaripour et al. Miswak toothpaste and gingival inflammation
Ingredients as listed on the packages
Calcium carbonate, sorbitol, aqua, silica, sodium lauryl sulphate, flavour,
Salvadora persica (Al-arak) extract, sodium carrageenan and/or sodium
carboxy methyl cellulose, sodium silicate, sodium benzoate, glycerine
and sodium saccharin
Sodium bicarbonate, aqua, glycerine, cocamidopropyl betaine, alcohol,
Krameria triandra extract, Echinacea purpurea flower/leaf/stem juice,
alcohol denat., xanthan gum, Chamomilla recutita extract, Commiphora
myrrha extract, sodium fluoride, sodium saccharin, sodium benzoate,
Salvia officinalis oil, Mentha piperita oil, Mentha arvensis oil and
limonene
Aqua, glycerine, hydrated silica, PVM/MA copolymer, sodium lauryl
sulphate, cellulose gum, aroma, sodium hydroxide, carrageenan,
sodium fluoride, triclosan, sodium saccharin and limonene
patients had to spend as little time as possible without oral
hygiene and did not have to be concerned about halitosis.
Patients were asked for the occurrence of any adverse effects,
had to complete a questionnaire and provide information about
the taste of the toothpaste used.
Approval
The study was approved by the Institutional Review Board
and the Ethics Committee of the University of Rhineland
Palatinate [837.540.13 (9225)]. All patients were informed ver-
bally and in writing about the nature of the investigation and
gave written consent for their participation.
Statistical analysis
Statistical analyses were conducted using the SPSS program
(version 22.0.0.0; SPSS Inc, Chicago, IL, USA) and SAS (ver-
sion 9.4; SAS Institute, Cary, NC, USA). Comparison of SBI
differences between the three groups was originally intended
to be performed using one-way ANOVA, followed by pairwise
t-tests. We assumed an effect size of 0.17 as occurs when dif-
ferences were equally spaced with a difference of 2.5
between subsequent groups and a standard deviation of 5.
An effect of this size can be demonstrated with 20 patients
per group at the 5% significance level with 80% power. It
was anticipated that some patients would discontinue partici-
pation in the clinical study, and therefore, we included 22
patients in each group. However, it appeared that the distri-
bution of the SBI differences was skewed. Therefore, a non-
parametric analysis using the Kruskal–Wallis test for overall
comparisons between groups was performed, followed by a
Mann–Whitney U-tests for pairwise comparisons. Changes
within treatment groups over time were assessed using Wil-
coxon signed rank tests. For further exploratory comparisons
between treatment groups, Kruskal–Wallis tests were used for
quantitative variables and chi-squared tests were used for cat-
egorical variables.
Int J Dent Hygiene | 3
Azaripour et al. Miswak toothpaste and gingival inflammation

Table 2. Demographic data of patients included in the study

Results
M-group P-group C-group
A total of 118 patients were assessed for eligibility and 66 (31 Group (n = 22) (n = 22) (n = 22) P-value
male, 35 female) met the inclusion and exclusion criteria and
Age 57.4  10.9 56.4  10.1 59.4  9.8 0.168*
could be analysed. The study flow diagram is shown in Fig. 1. Range 34–78 38–81 41–77
The participants were randomized and equally allocated to Gender
one of the three groups (each group thus comprised of 22 par- Female 16 5 14 0.327†
ticipants). Male 6 17 8
Pocket depth 2.8  0.3 2.8  0.2 2.8  0.2 0.279†
The groups did not differ with respect to age (mean age
57.8  10.2 years) and the gender distribution of participants Values represent descriptive means and standard deviations.
(female: 53%, male: 47%). The periodontal pocket depth was *Kruskal–Wallis test.
†
comparable between the groups (M-group: 2.8  0.2, P-group: Chi-squared test.
2.8  0.3, C-group: 2.8  0.2; Table 2).
personal assessments (Table 4). The majority of patients was
satisfied with the taste of the toothpaste, and no adverse side
Clinical outcomes effects were reported.
All patients in the M-group were satisfied with the taste of
The analysis of the data showed a significant reduction in SBI the toothpaste (100%), and most of the patients reported
and API in all groups after 21 days of brushing with the improved oral hygiene (72.7%). Most patients (91%) liked to
assigned toothpastes (Table 3). continue using it. The P-groups’ toothpaste was often
The P-group and the M-group had a significantly stronger described as salty (41%) and a third of the patients considered
reduction in SBI than the C-group. There was no significant it to be not pleasant to use (27%). Interestingly, 80% of the
difference between the M-group and the P-group (P = 0.466). patients reported an improvement in oral hygiene and 91% of
Furthermore, all groups showed a significant reduction in API the patients liked to continue using it. No displeasing taste
that was not significantly different between the groups. was reported in the C-group, even though 41% experienced
the toothpaste as being salty. Most of the patients (82%)
Compliance reported a good overall sensation.

All patients (n = 66) were asked to return the forms containing

details on the date and time of brushing. Furthermore,
Discussion
patients returned the questionnaire containing the subjective It has been shown that persica sticks are suitable accessories
rating of the taste of toothpaste, subjective oral sensations and for domestic oral hygiene (14, 16, 17), but their handling is

Fig. 1. Study flow diagram according to

CONSORT 2010.

4 | Int J Dent Hygiene

 Azaripour et al. Miswak toothpaste and gingival inflammation

Table 3. Clinical parameters at baseline and after 21 days (re-evaluation)

P-value P-value P-value

between between between
Clinical parameter M-group (n=22) P-group (n=22) C-group (n=22) M and P M and C P and C

Primary outcome
SBI
Baseline 46.4  19 46.2  19.5 41.2  18.4 0.842* 0.330* 0.372*
Re-evaluation 31.9  14.8 29.1  14.8 31.8  15.1 0.605* 0.934* 0.664*
P-value (intragroup differences) 0.001† 0.001† 0.001†
Reduction 14.5  8.1 17.1  9.1 9.4  7.8 0.466* 0.044* 0.002*
Secondary outcome
API
Baseline 73.3  20.3 79.9  20.6 72.2  17 0.208* 0.573* 0.078*
Re-evaluation 70.3  22.3 78  20.4 67.9  19.5 0.206* 0.769* 0.135*
P-value (intragroup differences) 0.012† 0.016† 0.001†
Reduction 3.0  5.9 1.9  3.3 4.3  5.2 0.304* 0.601* 0.075*

Values represent descriptive means and standard deviations for all indices.
*Mann–Whitney U test.
†
Wilcoxon signed rank test.

Table 4. Subjective outcomes

M-group n = 22 (%) P-group n = 22 (%) C-group n = 22 (%) P-value

Quality of taste of toothpaste

Spicy taste 0 (0) 2 (9.1) 0 (0) <0.001*
Bitter Taste 0 (0) 3 (16.6) 0 (0)
Fresh Taste 11 (50) 4 (18.2) 10 (45.45)
Salty taste 0 (0) 9 (40.9) 9 (40.90)
Neutral taste 9 (40.9) 3 (16.6) 12 (54.54)
Displeasing taste of toothpaste 0 (0) 6 (27.3) 0 (0%) <0.001*
Improvement of oral hygiene 16 (72.7) 19 (83.4) 14 (63.63) 0.222*
Less bleeding 2 (9.1) 4 (18.2) 2 (9.0)
Less gum redness 1 (4.5) 1 (4.5) 1 (4.5)
Less plasque accumulation 2 (9.1) 1 (4.5) 1 (4.5)
Cleaner sensation 16 (72.7) 19 (86.4) 14 (63.6)
Continue to use the toothpaste 20 (90.9) 20 (90.9) 19 (86.4) 0.852*
Overall sensation
Good 20 (90.9) 15 (68.2) 18 (81.8) 0.395*
Neutral 2 (9.1) 6 (27.2) 3 (16.6)
Bad 0 (0) 1 (4.5) 1 (4.5)

Values represent absolute numbers of individuals with a positive response; between brackets, percentages.
*Chi-squared test.

tedious. Therefore, there has been a growing interest in novel
dentifrices containing miswak extract.
In the present clinical study, the efficacy of a miswak
extract-containing toothpaste was tested on patients with gin-
givitis and was compared with that of a conventional toothpaste
(with predominantly chemically active ingredients) and a tooth-
paste with herbal ingredients. All dentifrices had a good accep-
tance and did not show any adverse side effects. All enrolled
participants completed the study without any withdrawal.
An observation period of 3 weeks was selected, because it
has been shown that this time span is sufficient to diagnose
changes in the degree of gingival inflammation (18, 19). At the
end of the 3-week period of tooth brushing, a considerable
reduction in the degree of gingival inflammation and amount
of plaque was found for all three toothpastes; however, those
with natural ingredients, the Miswak and Parodontax tooth-
pastes, reduced more effectively SBI than the conventional
toothpaste. These findings should be interpreted with caution,
because gingival inflammation level was moderate in all
patients and did not show a clinically relevant improvement
after 3 weeks of brushing. On the other hand, the reduction in
amount of plaque observed during the study period did not
show any significant differences, although oral hygiene of the
C-group was improved from insufficient to moderate, whereas
the other two groups remained insufficient.
The fact that patients who participated in this study showed
improved oral hygiene can be ascribed to the ‘Hawthorne phe-
nomenon’. It occurs in most clinical home-use studies (20).
Because of this phenomenon, the results of our study have to
be interpreted with caution.

Int J Dent Hygiene | 5

Azaripour et al. Miswak toothpaste and gingival inflammation
As mentioned before, a growing interest in the use of natu-
ral ingredient-containing dentifrices has been observed. Con-
sumers may be concerned that conventional oral healthcare
products, containing chemical additives, can cause sensitivity
and irritation of the oral mucosa (21, 22). Evidence for irrita-
tion of oral tissues, oral mucosa desquamation or recurrent
aphthous ulcer caused by dentifrice formulations has been
found in vivo and in vitro studies (23–28). As a consequence,
users of oral hygiene products prefer natural components and a
minimum of chemical additives in their toothpaste (29, 30).
Therefore, natural supplements in oral healthcare products
have become popular in the last decades, in particular in the
Western industrial world (31) and in Asian countries. For
example, in Thailand, extracts of the mangosteen tree have
been successfully applied as a natural antimicrobial adjunct in
addition to mechanical treatment of periodontal disease (32).
Another reason for the continuous use of natural oral hygiene
products is their relative accessibility, simplicity and their long
tradition. Miswak costs little and is easy available in many
parts of the world. It can be used anytime and anywhere, no
toothpaste is needed, and it lasts longer than common tooth-
brushes, which makes it very cost effective. So, miswak could
play an important role in the promotion of oral hygiene, espe-
cially in developing countries.
The efficacy of various toothpastes has been studied previ-
ously, but as far as we know, no studies have been published
yet comparing the efficacies of miswak extract-containing
toothpaste and a herbal and a conventional toothpaste, so that
the results from the present clinical study cannot be directly
compared with other studies.
However, in a clinical randomized study, Ozaki et al. (33)
compared the efficacy of Parodontax with that of a conven-
tional toothpaste (Colgate Totalâ). After 28 days, a similar sig-
nificant reduction in gingival bleeding and amount of plaque
was found after the use of both toothpastes as we found in the
present study. Ozaki et al. (33) found a higher reduction in
gingival bleeding (23–28%) and dental plaque (19%) compared
to our study. On the other hand, Pannuti et al. (18) reported a
lack of significant differences after the use of Parodontax or a
conventional toothpaste during a period of 3 weeks. In con-
trast, Yankell et al. showed a significant reduction in gingival
bleeding and plaque formation in a placebo-controlled clinical
trial using Parodontax (34). Its potential to reduce gingival
bleeding (35) and the activity of the protease matrix metallo-
proteinase-8 was discussed (36). Its effective buffering capacity
of sodium bicarbonate that stabilized the salivary pH and neu-
tralized acids in dental plaque was held responsible (37).
The conventional toothpaste contains triclosan and
polyvinylmethyl ether/maleic acid (PVM/MA) copolymers as
active ingredients. The use of toothpastes that contain tri-
closan and PVM/MA copolymers has been shown to improve
plaque parameters and gingival health (38–41). Triclosan has
shown to have an inhibitory effect in particular on Gram-nega-
tive microorganisms (42). Furthermore, its safety has been
examined and no negative side effects have been reported on
kidney or liver function as well as on oral hard and soft tissues
6 | Int J Dent Hygiene
(43). There is no evidence about triclosans to be hazardous to
humans (44). However, miswak extract-containing and herb-
containing toothpastes were shown to be more effective in
treating gingival inflammation in our study.
Therefore, we like to conclude that the present clinical
study demonstrates that all three tested toothpastes can be
recommended safely for daily domestic oral hygiene, because
all three showed anti-inflammatory effects but the miswak
extract-containing and herb-containing toothpastes seem to be
more effective. Further long-term studies are needed to con-
firm long-lasting benefits of miswak extract-containing tooth-
pastes.
Clinical relevance
Scientific rationale for the study
The use of miswak sticks as tooth-cleaning tools is an old tra-
dition, but their handling is tedious, and therefore, a miswak
extract-containing toothpaste was studied. In patients with
mild-to-moderate gingivitis, the effectiveness of a miswak
extract-containing toothpaste was compared with that of an
established herbal and a conventional toothpaste.
Principal findings
Three weeks of using miswak extract-containing toothpaste
significantly reduced gingival inflammation.
Practical implications
Our findings implicate that miswak extract-containing tooth-
paste can be recommended safely as alternative toothpaste.
Acknowledgements
The authors thank Prof. Dr. C.J.F. Van Noorden for his critical
reading of the manuscript.
Conflict of interest
The authors have no conflict of interest.
Funding statement
The authors have no external funding for this study to report.
This study was self-funded by the authors and supported by
their institution University Medical Centre, Johannes Guten-
berg University.
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Appendix 1
API [Lange et al. (15)]
Modified SBI [Lange et al. (15)]
Similar to the modified SBI, this dichotomous index regards
This dichotomous index (yes/no decision) regards the bleeding the interdental spaces alternating from the buccal or the lin-
in the interdental spaces after probing with a periodontal gual/palatal surfaces as described above. It evaluates interden-
probe. In the first quadrant, the spaces are checked from the tal plaque accumulation. For this purpose, plaque is stained
lingual/palatal side and in the second quadrant from buccal with plaque-disclosing tablets and thereafter the (maximum
side. The third quadrant is probed from lingual and the fourth 28) interdental spaces are scored quadrant-wise.
from buccal side again. In total, a maximum of 28 measuring The index is calculated as follows:
sites can be achieved. P
The index is calculated as follows: positive scored sites  100
P
P all available sites
positive scored sites  100
P
all available sites >70%, insufficient oral hygiene;
70–40%, moderate oral hygiene;
>50%, strong and generalized periodontal inflammation; 25–39%, acceptable oral hygiene;
>21–50%, moderate inflammation; <25%, optimal oral hygiene.

8 | Int J Dent Hygiene