Abdelsamie et al.

BMC Oral Health (2023) 23:506 BMC Oral Health

[Link]

RESEARCH Open Access

Clinical and biochemical assessment

of the effect of topical use of coenzyme Q10
versus topical corticosteroid in management
of symptomatic oral lichen planus: randomized
controlled clinical trial
Mostafa Abdelsamie1*, Fat’heya Zahran2, Amal A. Hussine3, Olfat Shaker4 and
Abdulaziz Mohsen Al‑mahallawi5,6

Abstract
Background Oral lichen planus (OLP) is a chronic mucocutaneous immunologically mediated condition that has a
great adverse effect on oral functions. Corticosteroids are still the first drugs of choice used in the treatment of OLP;
however, they have extensive medical side effects. The present study was carried out to assess the clinical therapeu‑
tic effect of the topical use of coenzyme Q10 (coQ10 or ubiquinol) versus topical corticosteroids in the manage‑
ment of symptomatic OLP and to determine whether the effect, if any, was due to the powerful antioxidant activity
of coQ10.
Subjects and methods We performed a randomized, double blinded controlled trial at the Faculty of Dentistry,
Cairo University, Egypt. The study was conducted on 34 patients suffering from symptomatic OLP. Patients were
randomly divided into two groups: intervention group (I),who received topical CoQ10 in the form of mucoadhesive
tablets (40% CoQ10) 3 times daily for one month and control group (II),who received topical corticosteroid (kenacort
in Orabase: triamcinolone acetonide 0.1% 5-g adhesive paste – dermapharm), 4 times daily for one month. Patients
were evaluated at one-week intervals using the clinical parameters (score) of pain (VAS) and lesion size. Additionally,
salivary levels of malondialdehyde (MDA) were detected in both groups before and after treatment using ELISA. All
recorded data were analysed using independent t test, ANOVA followed by Bonferroni post hoc test for lesion size
and salivary level of MDA data and Mann–Whitney U test and Friedman test for VAS data.
Results Both groups showed a significant reduction in pain and the size of the lesions (p ≤ 0.05) with no statisti‑
cally significant difference between them (p > 0.05), and this clinical improvement was associated with a reduction
in the salivary levels of MDA in both groups.
Conclusions The topical use of CoQ10 mucoadhesive tablets was as effective as the topical use of triamcinolone
acetonide, and its clinical effect was associated with a reduction in the salivary level of MDA.

*Correspondence:
Mostafa Abdelsamie
[Link]@[Link]
Full list of author information is available at the end of the article

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Abdelsamie et al. BMC Oral Health (2023) 23:506 Page 2 of 11

Trial registration The study protocol was registered at www.​clini​caltr​ial.​gov (NCT04091698) and registration date:
17/9/2019.
Keywords Oral lichen planus, Oxidative stress, Corticosteroids, Antioxidants, CoQ10, Malondialdehyde, Saliva

Introduction TNF-α promotes T-lymphocyte recruitment by upreg-

Oral lichen planus (OLP) is a relatively common ulating matrix metalloproteinase (MMP), which dis-
chronic mucocutaneous inflammatory immune-medi- rupts basement membrane integrity [46].
ated disease of the oral mucosa [28], it affects middle- A variety of treatments are used in the management of
aged females twice as much as males [14], with an OLP [16, 27]. Among these treatments, corticosteroids
estimated general population prevalence of 0.89% [28], are the gold standard treatment for OLP due to their anti-
and has recently been categorized as an oral poten- inflammatory and immunomodulatory actions through
tially malignant disorder by the World Health Organi- different mechanisms, including decreased leukocyte
zation (WHO) [60]. It has a variety of clinical forms, exudates into inflamed areas through the inhibition of
which may occur alone or in various combinations [20, vasodilation and vascular permeability, repressed tran-
52], where the atrophic and erosive forms are the most scription of many genes encoding proinflammatory
severe and are introduced to oral medicine clinics with cytokines, including NF-κB, suppressed adhesion mol-
severe burning sensation affecting different oral func- ecules expression, such as ICAM-1 and VCAM-1, and
tions [38]. regulation of Th1 responses and autoimmunity through
On the other hand, oral lichenoid lesions (OLLs) are a their direct effect on T cells with stimulation of IL10
term used to identify conditions that are clinically and secretion [12]. However, the long term use of steroids
histopathologically similar to OLP but with identifiable, showed different side effects ranging from atrophy of the
either local or systemic causes such as numerous medi- oral mucosa or secondary candidiasis, associated with the
cations, various dental materials (mercury-containing topical use of corticosteroid therapy [31], to more serious
amalgam restorations), and graft versus host disease systemic side effects, such as hypertension, osteoporosis
(GVHD). Compared to the traditional signs of OLP, and adrenal insufficiency, associated with the systemic
OLLs tend to be unilateral with histological examina- administration of corticosteroids [15, 62], resulting in a
tion showing more diffuse lymphocytic infiltration with continuing search for safer and more effective therapies.
more eosinophils, plasma cells, and colloid bodies. In Co enzyme Q10 is a lipid-soluble endogenous antioxi-
addition, it resolves once the cause is removed [24]. dant compound due to its ability to scavenge free radi-
Multiple factors [16] and immunological responses cals such as superoxide anion (O2•), hydrogen peroxide
[9] are implicated in the pathogenesis of OLP. Among (H2O2) and hydroxyl radical (OH•) [7]. It also augments
these, oxidative stress (OS) is implicated in both OLP the function of other endogenous antioxidants, such as
pathogenesis and carcinogenic potential [29]. Higher α-tocopherol (vitamin E) and ascorbate (vitamin C) [36,
salivary levels of reactive oxygen species (ROS), lipid 57]. In addition, it enhances other antioxidant enzymes,
peroxidation, nitric oxide, and nitrite support this such as superoxide dismutase (SOD), catalase (CAT)
theory [33], along with the obvious decrease in total and glutathione peroxidase [10]. In addition to the anti-
antioxidant activity and an increased level of salivary oxidant role of CoQ10, it has an anti-inflammatory role
oxidative markers in OLP patients compared to con- through its suppression to the gene expression of NFκB1
trols [53]. OS is defined as a disruption in the balance and the overproduction of proinflammatory cytokines
of pro-oxidant/antioxidant processes in biological such as TNF-α and interleukin-6 [8, 18],Furthermore, it
organisms [25]. It is produced by an excess of ROS or promotes the expression of anti-inflammatory cytokines
a breakdown in antioxidant functions. ROS can harm such as IL-10 [23], thus promoting tissue regeneration
human cells by causing protein, carbohydrate, lipid, and wound healing [51, 61].
and nucleotide damage [4].
In OLP lesions, ROS exacerbate inflammatory con-
ditions linked to immunological pathways through the
Subjects and methods
Study design
activation of NF-kB (nuclear factor kappa-light-chain-
The present study is a randomized controlled clinical trial
enhancer of activated B cells), a protein complex that
(two parallel groups) with an allocation ratio of 1:1. The
regulates proinflammatory gene transcription, such as
number of patients was equal in each group. The study
interleukin 2 (IL-2), tumor necrosis factor-alpha (TNF-
was conducted following the principles of the Helsinki
α), MHC class 1 gene, and IL-2 receptor gene [2, 30].
Declaration and was approved by the Research Ethics
Abdelsamie et al. BMC Oral Health (2023) 23:506 Page 3 of 11

Committee of the Faculty of Dentistry, Cairo University

(code: 19923).The protocol was registered at www.​clini​
caltr​ial.​gov (NCT04091698).

Study participants
The patients were recruited from the Diagnostic Center,
as well as the Clinics of the Oral Medicine and Periodon-
tology Department, at the Faculty of Dentistry, Cairo
University, during the period from September 2019 to
February 2022. According to specific inclusion and exclu-
sion criteria.

Inclusion criteria

(1) Patients were more than 18 years old.

(2) Patients were free from any systemic disease
according to the detailed questionnaire of the mod- Fig. 1 Opaque sealed jar containing mucoadhesive CoQ10 tablets
ified Cornell Medical Index [43].
(3) Patients clinically diagnosed by a dermatologist and
oral medicine specialist as suffering from OLP. Group I (intervention group)
(4) Patients who agreed to the biopsy in undiagnosed Seventeen participants received topical coenzyme Q10
cases. (ubiquinol) in the form of mucoadhesive tablets, (Fig. 1),
(5) Clinical and histopathological criteria were used 3 times daily for one month. All patients were instructed
according to modified WHO diagnostic criteria for to apply slight pressure for 1 min on the entire surface
OLP [59]. of the tablet using their finger and then let it dissolve
(6) Patients who were willing to participate in this without peeling it off. They were also instructed to avoid
study (who agreed to give informed consent) and bringing their teeth into contact with the tablets, to avoid
had the ability to complete the study. chewing or excessive jaw movements, and to avoid eat-
ing or drinking for at least 1 h following application of the
tablet [11]. They were also instructed to apply the tablet
on a single lesion that was the most painful lesion for the
Exclusion criteria patient, and found to be related to the buccal mucosa in
most cases.
(1) Patients taking systemic drugs such as systemic
steroids, or other immunosuppressive therapies for
CoQ10 mucoadhesive tablet preparation
at least 8 weeks prior to the study.
The tablets were prepared using 120 mg coQ10 powder
(2) Patients treated with any oral topical medications
(in reduced form which is the antioxidant form) [41],
for at least four weeks prior to the study.
mixed with mucoadhesive polymer 120 mg carbapol [42],
(3) Patients receiving any medication either topical or
and 60 mg anhydrous lactose [21], using a bench scale
systemic that could cause lichenoid reaction during
powder mixer continuously for 10 min. The components
the 3 months before the study.
of each tablet were fed manually into a 13 mm die and
(4) Patients with suspected restoration or drug-related
compressed using a constant compression force to pro-
lichenoid lesions.
duce tablets (40% coQ10 concentration) with a 13 mm
(5) Pregnant and lactating females.
surface area and hardness of 10 kgf (Fig. 2).

Group II (control group)

Study interventions
Seventeen participants received topical corticosteroid
The present study was conducted on 34 patients suffering
(kenacorte in Orabase: triamcinolone acetonide 0.1%
from symptomatic OLP. Patients were randomly divided
5-g adhesive paste – dermapharm), (Fig. 3), 4 times
into two groups and received both treatments in the form
daily for one month [26]. All patients were instructed to
of opaque sealed jars (Jar A) for adhesive tablets (Fig. 1)
apply a thin layer using a finger or cotton tip applicator,
and (Jar B) for triamcinolone paste (Fig. 3):
Abdelsamie et al. BMC Oral Health (2023) 23:506 Page 4 of 11

Study outcomes

1. Primary outcome

1.1. Pain measurement using the Visual Analogue

Scale: according to Maxwell [32]
All patients were asked to define their level of pain
and discomfort by using a numerical rating from 0
to 10 (11-points), with 0 indicating "no pain", 1 to
3 indicating mild pain, 4 to 6 indicating moderate
pain, 7 to 9 indicating sever pain and 10 indicating
"extremely painful".
1.2. Clinical improvement of the lesion, according
to Thongprasom et al. [56]

0 = no lesion
1 = white striae only
2 = white striae and atrophic ≤ 1 ­cm2
3 = white striae with atrophic > 1 ­cm2
4 = white striae with erosion ≤ 1 ­cm2
5 = white striae with erosion > 1 c­ m2
Fig. 2 Mucoadhesive CoQ10 tablets
The clinical score for each patient was calculated
by recording a score for each lesion in the oral cavity
separately using a graduated periodontal probe, and
then calculating the average of these scores.

2. Secondary outcome

2.1. Change in salivary level of malondialdehyde

detected at baseline and after treatment (after
4 weeks) using ELISA.
2.2. Change in Clinical global impression scale
detected from baseline to the end of treatment after
4 weeks, in which the patients rated overall change
in OLP symptoms during the treatment period
(patient global impression of change; PGI-C), choos-
ing 1 of 7 answers ranging from “very much bet-
ter” to “very much worse.” 1 = very much better/
improved, 2 = much better/improved, 3 = a little
better/improved, 4 = no change, 5 = a little worse,
6 = much worse, and 7 = very much worse.
Fig. 3 Opaque sealed jar containing triamcinolone acetonide paste

Saliva sample collection

Whole unstimulated saliva (WUS) was collected between
8 am to 1 pm using standard techniques according to
Miconazole 2% topical antifungal (Miconaz® oral gel:
considering not to eat, drink, or speak for at least 1 h.
Navazesh [37]. At the time of saliva collection, lesions
Miconazole 2 g per 100 gm) (Medical Union Pharma- were actively symptomatic, and subjects were asked not
ceuticals—MUP—Egypt) was applied after a 4 week fol- to eat, brush their teeth, or use mouth rinse at least 2 h
low- up period to avoid secondary candidiasis in this prior to salivary sample collection on that day. Samples
group [22]. were obtained by requesting subjects to swallow first, tilt
Abdelsamie et al. BMC Oral Health (2023) 23:506 Page 5 of 11

their heads forward, and expectorate 10 mL of unstim- Masking/blinding

ulated whole saliva into a sterile centrifuge tube. After Neither the statistician nor clinical outcome assessor
collection, the saliva was immediately centrifuged for (associate prof. AH) were aware of which medication was
2 min at 10,000 × g and the clarified supernatant was fil- being administered, thus yielding a double-blind con-
tered through a 0.45 μm low protein binding membrane, trolled study.
separated into 0.5 mL aliquots and frozen at − 80 ◦C until
assayed. Data collection and statistical analysis
All data collected from patients using clinical parameters
Determination of human malondialdehyde (MDA) in saliva
were recorded electronically for statistical analysis. Cat-
using an ELISA kit (prepared by Prof. OS)
egorical data are presented as frequencies (n), and per-
Saliva samples were centrifuged for 10 min at 4000 xg. centages (%), and the chi square test was used for the
The supernatant was separated and used for determina- analysis. Quantitative data were explored for normality
tion of MDA levels using ELISA Kit Cat No. MBS263626 using Kolmogorov–Smirnov and Shapiro–Wilk tests and
provided by My BioSource (USA, NY). This kit employs are presented as the mean and standard deviation (SD).
the “Double Antibody Sandwich” technique. The princi- Parametric data of age, lesion size and salivary level of
ple of double antibody sandwich is based on the charac- MDA were analyzed using independent t test for inter-
teristics of a target analytic with more than two possible group comparisons and repeated measures ANOVA fol-
epitopes that can be identified by both the precoated lowed by Bonferroni post hoc test. VAS data showed a
capture antibody and the detection antibody simultane- nonparametric distribution so they were analyzed using
[Link] this kit, the precoated antibody is an anti-human the Mann -Whitney U test for intergroup comparisons
MDA monoclonal antibody, while the detection antibody and the Friedman test of repeated measures for intra-
is a biotinylated polyclonal antibody. Samples and bioti- group comparisons. When the Friedman test was signifi-
nylated antibodies are added into ELISA plate wells and cant, it was followed by multiple pairwise comparisons
washed out with PBS or TBS after their respective addi- utilizing the Wilcoxon signed rank test with Bonferroni
correction. The significance level was set at P ≤ 0.05 for
all tests. Statistical analysis was performed with IBM®
tions to the wells. Then, avidin-peroxidase conjugates
SPSS® (SPSS Inc., IBM Corporation, NY, and USA) Sta-
were added to the wells. TMB substrate is used for col-
ouration after the enzyme conjugate has already been
thoroughly washed out of the wells by PBS or TBS. TMB tistics Version 26 for Windows.
reacts to form a blue product from the peroxidase activ-
ity, and finally turns yellow after addition of the stop solu- Results
tion (Color Reagent C). The color intensity and quantity During the recruitment phase, 36 patients were assessed
of target analytics in the sample are positively correlated for eligibility from September 2019 to February 2022.
[17]. Two patients did not meet the inclusion criteria due to
their chronic systemic diseases. Only thirty-four par-
ticipants were eligible for inclusion. All patients gave
Sample size calculation written informed consent and were randomly allocated
An interventional study by Thomas et al. [55] was used equally to the intervention group (n = 17), who received
by medical biostatistics unit members, Faculty of Den- topical mucoadhesive tablets, and the control group
tistry, Cairo University, to calculate sample size using an (n = 17), who received topical corticosteroids. No par-
independent t-test. The mean and standard deviation for ticipants were excluded during the follow up period
group 1 = 1.36 ± 1.11 while for group 2 = 2.47 ± 0.841,the (4 weeks) and all participants were analyzed, (Fig. 4).
alpha level of significance = 0.05, and the power of the The mean ± SD value of the ages in the intervention
study was [Link] sample size produced was 28 in both group was 35.82 ± 8.36 and for the control group it was
groups and increased by 20% to 34 (17 per group) to 38.41 ± 7.45. There was no significant difference between
compensate for drop-outs. the ages of the participants in both groups (P = 0.348). All
the participants in the intervention group were females.
In the control group, two (11.8%) of the participants were
Randomization and allocation concealment
males, while fifteen (88.2%) were females. There was no
Simple randomization was generated using www.​rando​
significant difference in gender distribution between
mizer.​org and performed by the principal investigator.
the groups (P = 0.485), (Table 1). Regarding the clinical
Allocation concealment was performed by placing the
characteristics of symptomatic OLP lesions, the atrophic
treatment assignment in sequentially numbered, opaque,
form of OLP occurred in 64.7% of the participants in the
sealed envelopes.
Abdelsamie et al. BMC Oral Health (2023) 23:506 Page 6 of 11

Fig. 4 CONSORT flow diagram of participants

Table 1 Demographic data of age and gender difference in VAS scores at different follow-up intervals
Groups Gender Age (Mean ± SD)
(p < 0.001). The highest (mean ± SD) value of VAS was
recorded at (week) (7.00 ± 1.06) in the intervention group
Male Female and (7.41 ± 1.00) in the control group, while the lowest
(n) % (n) % value was found at (4 weeks), which was (2.06 ± 1.92) in
the intervention group and (1.94 ± 2.08) in the control
Intervention (0) 0.0% (17) 100.0% 35.82 ± 8.36
group. Pairwise comparisons showed values measured
Control (2) 11.8% (15) 88.2% 38.41 ± 7.45
at (week) to be significantly higher than values measured
P-value 0.485 0.348S
at other intervals except for (2 weeks) (p < 0.05) in both
groups. Intergroup comparison showed that, at 4 weeks,
(the mean ± SD) value of VAS scores in the interven-
Table 2 Clinical characteristics of symptomatic OLP lesions in
both groups
tion group was slightly higher, while for other follow-up
intervals, the control group was higher; however, the dif-
Groups Atrophic OLP(n) Erosive OLP(n) ferences did not reach the level of significance (P > 0.05)
(n) % (n) % (Table 3).
Regarding the (mean ± SD) value of lesion size using
Intervention 11 64.7% 6 35.3%
the (Thongprasom scale), the intervention group
Control 9 52.9% 8 47.1%
showed a significant difference between lesion sizes
at different follow-up intervals (p < 0.001). The high-
est (mean ± SD) value of lesion size was recorded at
intervention group and 52.9% of the participants in the the first week (3.02 ± 0.87), while the lowest value was
control group, while the erosive form of OLP occurred in found at 4 weeks (1.37 ± 0.74). Pairwise comparisons
35.3% of the participants in the intervention group and showed that the value measured after one week was
47.1% of the participants in the control group (Table 2). significantly higher than the values measured at other
After the 4 week follow up period, both the inter- intervals except for 2 weeks (p < 0.05). In the control
vention group and control group showed a significant group, there was a significant difference between lesion
Abdelsamie et al. BMC Oral Health (2023) 23:506 Page 7 of 11

Table 3 Mean and standard deviation (SD) of VAS scores in both Table 5 Mean and standard deviation of salivary level of
groups and different follow-up intervals malondialdehyde (pg/ml) in both groups and different follow-up
intervals
Follow-up intervals (VAS) (Mean ± SD) P-value
Follow-up Salivary level of Malondialdehyde (pg/ P-value
Intervention Control
intervals ml) (Mean ± SD)
Week 7.00 ± 1.06A 7.41 ± 1.00A 0.222 ns Intervention Control
AB
2 weeks 5.18 ± 1.13 5.76 ± 0.90AB 0.159 ns
Before 7.08 ± 4.46 4.12 ± 2.37 0.022*
3 weeks 4.00 ± 1.22BC 4.06 ± 1.64BC 0.858 ns
C C After 5.92 ± 2.73 3.73 ± 2.25 0.016*
4 weeks 2.06 ± 1.92 1.94 ± 2.08 0.787 ns
P-value 0.311 ns 0.522 ns
P-value < 0.001* < 0.001*
ns nonsignificant (p > 0.05)
Different superscript letters within the same column indicate a statistically
significant difference*; significant (p ≤ 0.05) ns; nonsignificant (p > 0.05)

there was no significant difference between the groups

Table 4 Mean and standard deviation of lesion size in (P > 0.05) (Table 4 and Fig. 5).
(Thongprasom scale) in both groups and different follow-up In addition to the clinical assessment, the salivary level
intervals of malondialdehyde (pg/ml) before and after the treat-
Follow-up intervals Lesion size in thongprasom scale P-value ment in both groups was assessed which showed that
(Mean ± SD) the intervention group value of salivary level of malon-
Intervention Control
dialdehyde (pg/ml) measured before (7.08 ± 4.46) was
higher than value measured after treatment (5.92 ± 2.73),
A
Week 3.02 ± 0.87 3.43 ± 0.74A 0.148 ns however the difference was not statistically significant
(p = 0.311). Additionally the control group showed that
AB
2 weeks 2.64 ± 0.79 2.86 ± 0.79B 0.410 ns
3 weeks 2.18 ± 0.56B 2.09 ± 0.80C 0.692 ns the salivary level of malondialdehyde (pg/ml) measured
4 weeks 1.37 ± 0.74C 1.21 ± 0.90D 0.564 ns before treatment (4.12 ± 2.37) was higher than the value
P-value < 0.001* < 0.001* measured after treatment (3.73 ± 2.25) which was not
Different superscript letters within the same column indicate a statistically statistically significant (p = 0.522). At both intervals, the
significant difference*; significant (p ≤ 0.05) ns nonsignificant (p > 0.05) (mean ± SD) value of the intervention group was sig-
nificantly higher than that of the control group (P < 0.05)
(Table 5 and Fig. 6).
Finally, PGI-C assessing patient experience with their
OLP at end of dosing also showed clinically meaningful
improvements in both groups with 12/17 patients (70.5%)
in mucoadhesive Coq10 intervention group and 14/17
patients (82.3%) in the control group reporting their OLP
feeling much better or very much better.
Regarding drug safety in both groups, none of the par-
ticipants in either group reported any temporary or per-
Fig. 5 Line chart showing average lesion size in (Thongprasom scale)
manent adverse effects with either treatment during the 4
in different follow-up intervals
week follow up period.

sizes at different follow-up intervals (p < 0.001). The Discussion

highest (mean ± SD) value of lesion size was recorded The chronic nature of OLP, prolonged course of treat-
at week (3.43 ± 0.74), while the lowest value was found ment, and frequent exacerbation of the condition
at 4 weeks (1.21 ± 0.90). Pairwise comparisons showed increase the incidence of steroid side effects [15], there-
that the differences between values of follow-up weeks fore, the search for new treatment modalities has become
were all statistically significant (p < 0.05). Intergroup essential to overcome the side effects of the long term use
comparison showed that, at (3 weeks) and (4 weeks), of steroids. Among these, antioxidant and anti-inflamma-
the (mean ± SD) value of the intervention group was tory agents were proposed based on the role that might
slightly higher than that of the control group, while be played by oxidative stress in the pathogenesis of OLP
for other follow-up intervals (week and 2 weeks), the [5] and [33].
control group was higher. At all follow-up intervals, In addition to the antioxidant and anti-inflamma-
tory effects of CoQ10, its topical use in the form of
Abdelsamie et al. BMC Oral Health (2023) 23:506 Page 8 of 11

Fig. 6 Line chart showing the average salivary level of malondialdehyde (pg/ml) at different follow-up intervals

mucoadhesive tablets in the present study has many use of CoQ10 in combination with topical corticosteroids
advantages including intimate contact with the target improved the condition more than the topical use of cor-
mucous membrane, sustained drug release, increased ticosteroids alone.
drug absorption, and bioavailability, avoidance of enzy- In addition to the clinical assessment, the salivary levels
matic degradation in the GIT, and decreased adverse of MDA in both groups decreased after treatment with
drug effects [49]. Additionally, the systemic use of CoQ10 no significant difference. Therefore, we could assume that
was reported in a few cases to cause mild insomnia, the clinical improvement in both groups might be due to
rashes, nausea, and upper abdominal pain [39]. In our the anti-inflammatory effect of both corticosteroids [12]
study, the topical use of CoQ10 prevented the incidence and CoQ10 [8, 19], which directly have a great effect on
of these side effects. decreasing the secretion of proinflammatory cytokines
The mucoadhesiveness of these tablets is gained from such as TNF-α and subsequently, oxidative stress damage
the use of mucoadhesive carbapol polymer that rapidly [18, 35].
swells when touching the target area, thus providing However, it is expected that corticosteroids would have
sustained and controlled release of the drug from 6–8 h, a more potent anti-inflammatory effect than CoQ10.
and a strong mucosal adhesion effect [42]. Furthermore, Thus, it seems that while the decrease in oxidative stress
its topical use is safe with a nonsensitizing effect and no in the case of triamcinolone could be totally a result, in
effect on the biological activity of other drugs [40]. Anhy- the case of CoQ10, it is partly a result and partly due to
drous lactose was added to these tables to improve taste, the powerful antioxidant role of CoQ10 which was pre-
with no effect on the biological activity of the drug used viously detected by Ushikoshi-Nakayama et al. [58]. This
[21]. double action of CoQ10 could be the reason for its effect
Up to our knowledge, the current study is the first ran- being equivalent to that of triamcinolone.
domized control clinical trial evaluating the effectiveness Topical CoQ10 has been previously investigated in
of topical use of CoQ10 in the management of sympto- other oral conditions, such as periodontal and gingival
matic OLP. Consequently, no similar previous studies are conditions, and showed a great clinical reduction in the
available for comparison with our results. Shoukheba and inflammatory condition after a few weeks [13, 44, 45, 48].
Elgendy’s [54] study is the only one where CoQ10 was Comparing our study with other studies using antioxi-
tried for the management of OLP, but in the systemic dant agents in the management of OLP, such as selenium
form of 30 mg CoQ10 capsules, combined with topical -ACE [6], selenium [46], Aloe vera (AV) [1], curcumin
corticosteroid. [47], lycopene [50], quercetin [3] and ozone therapy
The results of the current study showed that the topical [34],we can deduce that, coQ10 can be used as an alterna-
use of CoQ10 mucoadhesive tablets significantly reduced tive treatment or in combination with corticosteroids for
both pain sensation and clinical signs with maximum OLP management, similar to other antioxidants, exclud-
clinical improvement at the fourth week and no signifi- ing quercetin which did not show any significant differ-
cant differences when compared with the results of topi- ence when added to topical corticosteroids compared
cal corticosteroid. The effective role of the topical use of with the placebo treatment [3]. In addition, coQ10 was
CoQ10 was also seen in the study conducted by Shouk- sufficient to improve the oral condition clinically when
heba and Elgendy [54], who reported that the systemic taken in daily small doses for a short period (4 weeks),
Abdelsamie et al. BMC Oral Health (2023) 23:506 Page 9 of 11

unlike curcumin, which improved the oral condition after Acknowledgements

The authors of the study would like to express the greatest thanks to all the
being taken in large amounts for a long period [47]. Only staff members of the Oral Medicine Department, Faculty of Dentistry, and
a few studies have measured salivary MDA levels, includ- Cairo University for their cooperation, kind feelings and for sparing no effort in
ing selenium [46], and curcumin [47], which showed the helping us, as well as many thanks to Mepaco_Arab Co. For Pharmaceuticals
and Medicine for supplying us with the powder of Co enzyme Q10 .Finally,
antioxidant effect of systemic use of selenium and cur- we would like to express a lot of thanks to all patients who participated in the
cumin, as seen with the topical use of coQ10 in our study. study.
The study was limited by the short follow-up, precluding
Authors’ contributions
the opportunity to evaluate the relapse rate and the effect M.A. responsible for the funding and undergoing the clinical and theoretical
of topical use of CoQ10 when used for a long duration. work of the trial, collecting data, clarification, conclusions and drafting the
Furthermore, the small sample size recommended the manuscript. F.Z. responsible for patients’ randomization, providing guidance
through the clinical work, revising the theoretical part and help with the con‑
need for more clinical trials to conclude the effective role clusions and completion of the data. A.H. responsible for clinical assessment
of CoQ10 in the management of symptomatic OLP. of patients, cases selection, clinical diagnosis as well as help in writing the
manuscript. O.S. responsible for Biochemical assessment of salivary samples
using enzyme-linked immunosorbent assay (ELISA), interpretation of results
Conclusions and drawing conclusions. A.A. responsible for Coenzyme Q10 mucoadhesive
tablets preparation. All authors read and approved the final manuscript.

1. Topical application of mucoadhesive CoQ10 tablets Funding

on symptomatic OLP lesions leads to significant pain Open access funding provided by The Science, Technology & Innovation
Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank
relief and clinical improvement of the condition in (EKB). Self-funded.
addition to decreasing the salivary levels of one of the
markers of oxidative stress (MDA). Availability of data and materials
The datasets used and/or analyzed during the current study are not publicly
2. CoQ10 in a mucoadhesive formula is as effective as available due [for better patient data confidentiality] but are available from the
the standard treatment triamcinolone acetonide in corresponding author on reasonable request.
reducing pain scores and lesion size in OLP.
3. Topical CoQ10 as an antioxidant and anti-inflamma- Declarations
tory agent together with its analgesic effect is a safe
Ethics approval and consent to participate
treatment modality for symptomatic OLP, with no The study was conducted following the principles of the Helsinki Declara‑
apparent side effects. tion and was approved by the Research Ethics Committee of the Faculty of
Dentistry, Cairo University (code: 19923). All patients were informed about the
nature and objectives of the study. All participants read, approved, and signed
a written informed consent form that was reviewed by the ethics committee
of scientific research – Faculty of Dentistry– Cairo University.
Recommendations
Consent for publication
1. Studies with larger sample sizes are needed to con- Not applicable.
clude the effective role of CoQ10 in the management Competing interests
of symptomatic OLP. The authors declare no competing interests.
2. Different concentrations of CoQ10 need to be used
Author details
to reach the optimum dose required to achieve opti- 1
Oral Medicine, Faculty of Dentistry, Cairo University, Cairo, Egypt. 2 Oral
mum management of OLP with no side effects. Medicine, Faculty of Dentistry, Cairo University, Cairo, Egypt. 3 Oral Medicine,
3. The period between lesion remission and exacerba- Faculty of Dentistry, Cairo University, Cairo, Egypt. 4 Medical Biochemistry
and Molecular Biology, Faculty of Medicine, Cairo University, Cairo, Egypt.
tion for CoQ10 should be measured. 5
Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy,
4. Evaluation of CoQ10 use for a long duration is also Cairo University, Cairo, Egypt. 6 School of Life and Medical Sciences, University
needed. of Hertfordshire Hosted By Global Academic Foundation, New Administrative
Capital, Cairo, Egypt.

Received: 6 January 2023 Accepted: 6 July 2023

Abbreviations
OLP Oral lichen planus
CoQ10 Co enzyme Q10 References
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