Med O al Pa ol O al Ci Bucal. 2015 May 1;20 (3):e378-85. Bioadhesi e chlo hexidine gel and mucosi is
e378
Jou nal sec ion: O al Su ge y
Publica ion Types: Resea ch
Double-blind, andomized pilo s udy o bioadhesi e chlo hexidine
gel in he p e en ion and ea men o mucosi is induced
by chemo adio he apy o head and neck cance
Rosa-Ma ia Diaz-Sanchez 1, Je ónimo Pachón-Ibáñez 2, Fá ima Ma ín-Conde 1, Ángela Rod íguez-Caballe o 1,
Jose-Luis Gu ie ez-Pe ez 1,2, Daniel To es-Laga es 1
1 Den al School. Uni e si y o Se ille
2 “Vi gen del Rocío” Uni e si y Hospi al
Co espondence:
Depa amen o S oma ology
School o Den is y - Uni e si y o Se ille
“Vi gen del Rocío” Uni e si y Hospi al
C/ A icena s/n 41009. Se ille. Spain
daniel [email protected]
Recei ed: 26/08/2014
Accep ed: 23/10/2014
Abs ac
Backg ound: To e alua e, in an ini ial way, he e ec i eness o bioadhesi e chlo hexidine gel 0.2% e sus placebo
as a p e en i e and he apeu ic in e en ion o o al mucosi is induced by adia ion he apy and chemo he apy in
pa ien s diagnosed wi h head and neck cance ea ed wi h chemo adio he apy.
Ma e ial and Me hods: �n his pilo s udy, 7 pa ien s ( ange o age: 18- 65), ha ing his ological documen ed diag-Me hods: �n his pilo s udy, 7 pa ien s ( ange o age: 18- 65), ha ing his ological documen ed diag-e hods: �n his pilo s udy, 7 pa ien s ( ange o age: 18- 65), ha ing his ological documen ed diag-- 65), ha ing his ological documen ed diag- 65), ha ing his ological documen ed diag-
nosis o squamous ca cinoma on he head and neck egion in s age ��� and �V, and ecei ing combined adia ion
ea men and chemo he apy (cispla in 100 mg/m2 �V on days 1, 22, and 43 o i adia ion) we e s udied. Simul-
aneously, a opical applica ion was pe o med wi h bioadhesi e chlo hexidine gel 0.2% in he s udy g oup, and
he placebo gel o he con ol g oup in 5 applica ions pe day, om he ime o ini ia ion o cance ea men o
2 weeks a e comple ion o chemo- adio he apy ea men (11 weeks o ollow-up). The g ada ion o mucosi is,
pain, analgesic consump ion, in ec ious complica ions, and ea men ole ance was measu ed.
Resul s: A e 7 pa ien s comple ed he p o ocol, any di e ences we e obse ed be ween g oups in an in e al
analysis. Mucosi is, pain, and ole ance was simila in bo h g oups.
Conclusions: Ou esul s mus be in e p e ed wi h cau ion due o he educed sample size, bu he use o bioad-
hesi e chlo hexidine gel 0.2% didn’ con ibu e clinical imp o emen o he o al mucosi is induced by adia ion
he apy and chemo he apy.
Key wo ds: Chlo hexidine, mucosi is, head and neck cance .
Diaz-Sanchez RM, Pachón-�báñez J, Ma ín-Conde F, Rod íguez-Caba-
lle o Á, Gu ie ez-Pe ez JL, To es-Laga es D. Double-blind, andomi-. Double-blind, andomi-Double-blind, andomi-
zed pilo s udy o bioadhesi e chlo hexidine gel in he p e en ion and
ea men o mucosi is induced by chemo adio he apy o head and neck
cance . Med O al Pa ol O al Ci Bucal. 2015 May 1;20 (3):e378-85.
h p://www.medicinao al.com/medo al ee01/ 20i3/medo al 20i3p378.pd
A icle Numbe : 20338 h p://www.medicinao al.com/
© Medicina O al S. L. C.I.F. B 96689336 - pISSN 1698-4447 - eISSN: 1698-6946
eMail: [email p o ec ed]
Indexed in:
Science Ci a ion �ndex Expanded
Jou nal Ci a ion Repo s
�ndex Medicus, MEDL�NE, PubMed
Scopus, Embase and Emca e
�ndice Médico Español
doi:10.4317/medo al.20338
h p://dx.doi.o g/doi:10.4317/medo al.20338
Med O al Pa ol O al Ci Bucal. 2015 May 1;20 (3):e378-85. Bioadhesi e chlo hexidine gel and mucosi is
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In odu ion
O al mucosi is (OM) is conside ed one o he majo de-
bili a ing side e ec s o cance he apy due o he di-
ec adia ion o he mucosa wi h adio he apy o by he
e ec o chemo he apy (1,2). This illness is desc ibed
as he esul o in lamma ion changes in he epi helial
and sub-epi helial cells i adia ed o a ec ed by he
ea men , causing discom o in he pa ien s because o
he gene alized e y hema, ank ulce a ion, and denu-
da ion, associa ed wi h local pain as well, which cons-
i u es he mos impo an clinical mani es a ions o
o opha yngeal mucosi is (1,3). The induced pain makes
i di icul o pa ien s o ea , swallow, speak, o pe o m
o al hygiene measu es. These e ec s esul in weigh
loss, dehyd a ion, and a isk o o al in ec ions (1).
Today, adio he apy (RT) and chemo he apy (QT) cons-
i u e as one o he mos commonly used combina ions
o he apies o head and neck cance (H&NC). � has
been demons a ed in p e ious s udies ha he associa-
ion o hese ypes o ea men s esul mo e e ec i ely
han using adio he apy alone. Ac ually, he mos e-
quen ea men is he p og ammed sessions o QRT,
being necessa y in mos cases o su gical in e en ion
oo. The ea men mus be unin e up ed; i has been
demons a ed ha he p oli e a ion isk o esidual u-
mo cells is inc emen ed when he adio he apy o he
p og ammed chemo he apy is abandoned o in e up-
ed, causing ecu ences o he umo and a ec ing he
li e quali y o he pa ien (4).
Nine y pe cen o pa ien s wi h head and neck cance e-
cei ing s anda d adio he apy and chemo adio he apy
will de elop o opha yngeal mucosi is (3), a ying he
incidence acco ding o he oncology ea men schedule
(5).
�n ao al lesions a e commonly localized in non-que-
a inized o al mucosa, such as lip and buccal mucosa,
la e al and an e io mucosa o he ongue, loo o he
mou h, and so pala e. The ha d pala e and gums seem
o be less suscep ible o he e ec s o chemo he apy and
adio he apy (6).
In a con en ional adio he apy, he i s adia ion dose
(10 Gy) causes a hipe que a inized lesion, whe e a whi-
ish appea ance can go unno iced. An ea ly sign o OM
includes e y hema, which appea s a e app oxima ely
20 Gy o cumula i e adia ion dosage o head and neck
umo s. A e 7–10 days, o a cumula i e dosage o 30
Gy, ulce s co e ed by a pseudomemb ane a e de ec ed;
hese pseudomemb anes b ing on he bac e ial coloni-
za ion wi h a high isk o sob ein ec ion, which a e as-
socia ed wi h discom o and changes in pa ien die a y
habi s. Radio-induced OM las s o a leas 2 o 6 weeks
a e adia ion he apy has inished (7,8).
OM induced by chemo he apy is usually mo e agg es-
si e han ha caused by adio he apy. A e 5-8 days
o ea men , e y hema appea s, and 2 days a e , edema
and ulce a ion can be obse ed (7). E y hema is obse -
ed a ound he i h–eigh h day o ea men , and in he
ollowing days, edema and ulce a ion can be obse ed.
A e he end o he chemo he apy ea men , he mucosa
will need abou 7-10 days o eco e comple ely (7).
Nowadays, he e a e a la ge numbe o ea men s ha we
can choose om, bu he s a egies o educe o al muco-
si is a e s ill unclea . Due o he impo ance o he OM,
many s udies ha e been ca ied ou . Di e en echniques
ha e been desc ibed like in ensi e o al ca e p o ocol,
an imic obial agen s, an iin lamma o y agen s, ci op o-
ec o s agen s, nu i ional supplemen s, bioes imulan s
agen s, o na u al and homeopa hic agen s. Al hough all
o hese ea men op ions exis (6,9-11) o p e en and
ea mucosi is, he e is no gold-s anda d p o ocol ha
is p ominen ly be e han he es because he e is no
enough e idence desc ibing a ea men wi h p o en e i-
ciency o su pass he o he ea men s o his condi ion
(6,9,12-14).
Chlo hexidine is app o ed o use as an an ibac e ial
mou hwash a a concen a ion o 0.12% and 0.2% o p e-
en he build-up o den al plaque and o p e en gingi-
i is (9,15). � s b oad spec um o an ibac e ial ac i i y,
minimal sys emic abso p ion, and abili y o bind o o al
su aces led o he use o p ophylaxis in an a emp o p e-
en he de elopmen o o al mucosi is (16). Howe e , i
has some disad an ages such as he discolo a ion o ee-
h, he bi e as e, and he unpleasan sensa ion (17,18).
The aim o his pilo s udy was o e alua e, in an ini-
ial way, he e ec i eness o bioadhesi e chlo hexidine
gel 0.2% e sus placebo as a p e en i e and he apeu ic
in e en ion o o al mucosi is induced by adia ion he-
apy and chemo he apy in pa ien s diagnosed wi h head
and neck cance ea ed wi h chemo adio he apy.
Ma e ial and Me hods
- Pa ien Cha ac e is ics and place o s udy
The pilo s udy was conduc ed in he oncology de-
pa men o he Uni e si y Hospi al “Vi gen del Rocío”
in Se ille a e app o al om he local �n e nal Re iew
Boa d. This was a p ospec i e, placebo-con olled, an-
domized, and double-blind pilo s udy.
The inclusion c i e ia was he ollowing: pa ien s aged
18-65, who had his ological documen ed diagnosis o
squamous ca cinoma on he head and neck egion in
s age III and IV acco ding o he TNM classi ica ion
and who ecei ed combined adia ion ea men (con-
en ional ac iona ion 70 Gy eaching he umo and
a ec ed lymph nodes, and 50 Gy a he nodal a eas d a-
inage in 9 weeks) and chemo he apy (cispla in 100 mg/
m2 �V on days 1, 22, and 43 o i adia ion). The pa ien s
olun a ily exp essed hei in en ion o pa icipa e in
he clinical ial wi h in o med consen be o e en olling
in he s udy.
The exclusion c i e ia was he ollowing: pa ien s who
Med O al Pa ol O al Ci Bucal. 2015 May 1;20 (3):e378-85. Bioadhesi e chlo hexidine gel and mucosi is
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ha e hype sensi i i y o an alle gy o any o he compo-
nen s included in he s udy, pa ien s wi h H�V, diabe es
and au oimmune diseases, and hose who do no ul ill
all o he inclusion c i e ia men ioned abo e.
A e ca ying ou his pilo s udy, 7 egis e ed pa ien s,
4 in he s udy g oup, and 3 in he con ol g oup, he s udy
was s opped. All he pa ien s ul illed he pilo s udy.
- S udy g oups
Expe imen al/s udy g oup: �n he p o ocol o ea men ,
hese pa ien s pe o med opical applica ion wi h bio-
adhesi e chlo hexidine gel 0.2%. �n he con ol g oup,
hese pa ien s used a placebo gel in he way ha we spe-
ci y below.
- S udy design
The s udy p o ocol consis ed o he adminis a ion o a
mul i i amin ha con ained i amin E and Zinc Sul a e,
he pe o mance o inses wi h 15 ml o Benzydamine
o 2 minu es, 5 imes a day, and he local applica ion o
ice on he o al mucosa a leas o 20 minu es on days 1,
22, and 43 o cance ea men (a e chemo he apy wi h
cispla in), besides he applica ion o adio he apy o 9
weeks (exposed p e iously).
Simul aneously, opical applica ion was pe o med wi h
bioadhesi e chlo hexidine gel 0.2% in he s udy g oup
and placebo gel o he con ol g oup in 5 applica ions
pe day om he ime o ini ia ion o cance ea men
o 2 weeks a e comple ion o chemo- adio he apy
ea men ( o al ime o s udy was 77 days, 11 weeks).
The pa ien was ins uc ed in he placemen o he gel
(placebo o chlo hexidine) wi h a sy inge by ex ac ing
a dose o 10 ml o each applica ion, 5 imes pe day,
a e insing wi h benzydamine.
The andomiza ion and double-blind ial was ca ied
ou as ollows. Bo h gels we e p epa ed by LACER la-
bo a o ies in Ba celona (Spain). The needed ha dwa e
was added o all samples o ha e iden ical colo , la o ,
and ex u e, which in u n would be com o able o he
pa ien . Pa ien s we e andomly assigned o ecei e ei-
he p o ocol o o al ca e wi h chlo hexidine o placebo
by selec ion o a sealed en elope ( andomized lis gene-
a ed by compu e ).
The pa ien sco ed daily in a bookle p o ided below o
he onse o pain and i s in ensi y be o e applying he
gel, immedia ely a e , and 3 hou s la e (using a isual
analog scale numbe ed om 0 o 100) in he i s appli-
ca ion o he gel du ing he day. � was also no ed in his
bookle i he use o analgesics and/o an i-in lamma-
o y o al mucosi is was equi ed, and in wha quan i y
(numbe o pills and doses).
The s udy was planned and ca ied ou in compliance
wi h he Decla a ion o Helsinki and Good Clinical
P ac ice. The pilo s udy p o ocol was app o ed by he
Expe imen a ion E hics Commi ee (EC) o he Uni e -
si y o Se ille and inanced by he Andalusian Heal h
Se ice (Code S�G�- S0095).
- Clinical assessmen p o ocol
G ada ion, occu ence, and emission o mucosi is
The in eg i y o he mucosa was assessed using he
WHO c i e ia o he g ading o o al mucosi is on a
scale o 0–4, whe e 0 is “no change,” 1 co esponds
o “e y hema and/o pain,” 2 “ulce a ion and abili y o
ea ,” 3 “ulce a ion and limi ed abili y o ea ,” and 4 “ul-
ce a ion wi h hemo hage and nec osis.” The examine
is always he same o a oid he a iabili y be ween di-
e en examine s’ c i e ia.
�ni ial explo a ion o he o al mucosa is eco ded be o e
he beginning o chemo- adio he apy, and subsequen
e iews we e ca ied ou weekly un il 2 weeks a e he
ull cance ea men o he pa ien s.
- Pain
Pa ien s a ed pain sensa ion ollowing a isual analo-
gue scale (VAS) la wi h alues anging om 0 (“no
pain”) and he alue 100 (“unbea able pain”). This an-
no a ion was made a home once a day h oughou he
s udy, be o e applying he gel, immedia ely a e , and 3
hou s a e ( i s daily gel applica ion).
- Adju an analgesics
Pa ien s eco ded in he same bookle i hey ook anal-
gesics o an i-in lamma o ies due o mucosi is, and hey
speci ied he amoun o d ugs equi ed on a daily basis.
- T ea men ole ance
The e alua ion o ole ance was based on he equency
wi h which pa ien s ha e had a leas one ad e se e en
du ing he ial. The pa ien and in es iga o will sco e
he global ole ance a he end o ea men by an o al
5-poin scale: 5 = e y good, 4 = good, 3 = mode a e, 2
= poo , and 1 = e y poo .
- �n ec ious complica ions
The in es iga o assessed he occu ence o complica-
ions due o in ec ion o he lesions o mucosi is in wee-
kly e iews du ing ea men .
- Da a analysis
Da a we e analyzed using SPSS 9 o Windows Suppo
Uni Resea ch Hospi al Uni e si a io “Vi gen del Ro-
cio.” We used he chi-squa e es o he analysis o he
da a ob ained in he compa ison o quali a i e a iables
and Mann–Whi ney U es o compa ison o means.
Resul s
�n his pilo s udy, 7 pa ien s wi h head and neck ca ci-
noma ea ed wi h chemo- adio he apy we e andomi-
zed and included in he in en ion- o- ea popula ion o
e icacy analyses. The pa ien s consis ed o 5 men and
2 women wi h mean age o 59.57 ± 10.97 yea s. �n he
con ol g oup, 3 pa ien s we e ea ed wi h a mean age
o 63.3 ± 15.89 yea s. �n he expe imen al g oup, 4 pa-
ien s we e ea ed wi h an a e age age o 56.75 ± 6.90
yea s (Table 1). All pa ien s we e unde going ea men
chemo- adio he apy.
Rega ding he equency o he hygienic habi s, 4 pa-
Med O al Pa ol O al Ci Bucal. 2015 May 1;20 (3):e378-85. Bioadhesi e chlo hexidine gel and mucosi is
e381
ien s had a equency o 3 imes pe day, 2 pa ien s 2
imes pe day, and 1 o hem 1 ime pe day. Howe e ,
in e ms o ha m ul habi s, only 2 pa ien s had no such
habi , 2 o hem we e ex-smoke s, 2 we e smoke s and
d inke s, and one o hem was a d inke (Table 2).
The in eg i y o he mucosa o he WHO scale o mu-
cosi is was sligh ly highe in he s udy g oup han in he
con ol g oup, bu wi hou ob aining s a is ically signi-
ican di e ences (p>0.05) (Table 3).
�n ela ion o he pain associa ed wi h he applica ion
o gel, a g ea e deg ee o pain p io o placemen in
he s udy g oup han in he con ol g oup was obse ed
(Fig. 1), al hough he pain a he ime o gel applica-
ion and 1 hou la e o placemen was less in he s udy
g oup e sus he con ol g oup (Figs. 2,3). Howe e , no
di e ences in ends we e ound be ween he chlo hexi-
dine and placebo.
The ole ance o he ea men om he pa ien s’ and
esea che s’ poin o iew had he same punc ua ion on
he scale om 1 o 5. �n he s udy g oup, he ole ance
was sligh ly be e han in he con ol g oup (Table 4).
Mo eo e , in ec ious complica ions we e simila in he
expe imen al g oup han in he con ol g oup (Table 5).
No s a is ically signi ican di e ences we e ound in
any o he wo a iables (p>0.05).
Table 1. Cha ac e is ics o he pa ien s included in he s udy.
AGE (yea s) SEX TOTAL OF
PATIENTS
Men Women
CHX 0,2% 56.75 ± 6.90 3 1 4
Placebo 63.33 ± 15.89 2 1 3
To al 59.57 ± 10.97 5 2 7
SMOKING HABIT HYGIENIC HABIT
No
Smoke
10-20
ciga e es
20
ciga e es
Ex-
Smoke To al 1 Tee h
b ushing
2 Tee h
b ushing
3 Tee h
b ushing To al
CHX
0,2% 1 1 0 2 4 0 2 2 4
Placebo 1 1 1 0 3 1 0 2 3
To al 2 2 1 2 7 1 2 4 7
Table 2. Habi s o he pa ien s included in he s udy.
Table 3. The in eg i y o he mucosa o he WHO scale o Mucosi is along he s udy.
CHX 0,2% Placebo Signi icance
1 2 3 4 5 1 2 3 4 5
1 Week 4(100%) 0(0%) 0(0%) 0(0%) 0(0%) 3(100%) 0(0%) 0(0%) 0(0%) 0(0%) 0.999
2 Week 2(50%) 1(25%) 1(25%) 0(0%) 0(0%) 3(100%) 0(0%) 0(0%) 0(0%) 0(0%) 0.350
3 Week 0(0%) 2(50%) 0(0%) 2(50%) 0(0%) 1(33%) 1(33%) 1(33%) 0(0%) 0(0%) 0.233
4 Week 0(0%) 1(25%) 0(0%) 3(75%) 0(0%) 0(0%) 3(100%) 0(0%) 0(0%) 0(0%) 0.030
5 Week 0(0%) 1(25%) 1(25%) 1(25%) 1(25%) 0(0%) 0(0%) 3(100%) 0(0%) 0(0%) 0.268
6 Week 0(0%) 1(25%) 1(25%) 1(25%) 1(25%) 0(0%) 0(0%) 0(0%) 3(100%) 0(0%) 0.268
7 Week 0(0%) 1(25%) 1(25%) 1(25%) 1(25%) 0(0%) 0(0%) 0(0%) 3(100%) 0(0%) 0.268
8 Week 1(25%) 0(0%) 1(25%) 1(25%) 1(25%) 0(0%) 0(0%) 0(0%) 3(100%) 0(0%) 0.268
9 Week 1(25%) 0(0%) 2(50%) 0(0%) 1(25%) 0(0%) 0(0%) 0(0%) 3(100%) 0(0%) 0.072
10 Week 0(0%) 1(25%) 1(25%) 1(25%) 1(25%) 0(0%) 0(0%) 0(0%) 3(100%) 0(0%) 0.268
11 Week 1(25%) 0(0%) 2(50%) 0(0%) 1(25%) 0(0%) 3(100%) 0(0%) 0(0%) 0(0%) 0.072
Med O al Pa ol O al Ci Bucal. 2015 May 1;20 (3):e378-85. Bioadhesi e chlo hexidine gel and mucosi is
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Fig. 1. Pain p io o placemen he gel in he s udy g oup han in he con ol g oup.
Fig. 2. Pain a he ime o gel applica ion.
Med O al Pa ol O al Ci Bucal. 2015 May 1;20 (3):e378-85. Bioadhesi e chlo hexidine gel and mucosi is
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Discussion
This is a epo o a pilo s udy. The calcula ions o he
sample ha we e necessa y o ex apola e he da a once
hey we e d awn om he s udy sample we e ca ied
ou and he o al numbe o pa ien s was calcula ed as
96. Howe e , he au ho s ha e decided no o ad ance in
his inal s udy. The easons o his included he e y
limi ed e ec i eness (i some a e p esen ) o he d ug
used in he s udy g oup (chlo hexidine gel 0.2%) com-
pa ed o placebo.
Da a om se e al andomized clinical ials show ha
chlo hexidine inses do no ha e a majo impac on he
p e en ion o mucosi is in pa ien s unde going adio he-
apy (18,19). Howe e , i signi ican ly seems o educe
o al in lamma ion and ulce a ion in pa ien s unde going
chemo he apy. Chlo hexidine inses a e ea men s ha
a e applied ac oss he su ace o he o al ca i y wi hou
ac ing speci ically on lesions, so he use o chlo hexidi-
ne gel would seem o ha e a mo e ad an ageous indi-
ca ion o he ea men o inju ies caused by mucosi is
because o he localized applica ion (20).
�n opposi ion o he ini ial hypo hesis, ou esul s don’
show a clinical imp o emen o he s udy g oup’s pa-
ien s. The use o bioadhesi e chlo hexidine gel 0.2%
does no educe he equency o mucosi is in he o al
ca i y o he pain caused by mucosi is induced by can-
ce ea men , and wi h no signi ican di e ences be -
ween he pa ien s’ pain be o e and a e he applica ion
o i . These esul s a e in ag eemen wi h o he wo k
wi h chlo hexidine inse, as in he pape p esen ed by
Ru kauskas and Da id (21), who in es iga ed he e ec
o chlo hexidine e sus a placebo in pa ien s unde -
Fig. 3. Pain one hou a e he applica ion.
Pa ien Obse a ion Resea che Obse a ion
1 2 3 4 5 Signi icance 1 2 3 4 5 Signi icance
CHX 0,2% 0 1 2 1 0 0.646 0 1 2 1 0 0.646
Placebo 0 0 2 1 0 0 0 2 1 0
Table 4. Tole ance o he ea men om he Pa ien and he Resea che View.
INFECTIOUS
COMPLICATION
NO INFECTIOUS
COMPLICATION Signi icance
CHX 0,2% 2 (50%) 2 (50%) 0.659
Placebo 2 (66%) 1 (33%)
Table 5. �n ec ious Complica ion on he s udy and con ol g oup.
Med O al Pa ol O al Ci Bucal. 2015 May 1;20 (3):e378-85. Bioadhesi e chlo hexidine gel and mucosi is
e384
going haema opoie ic s em cell ansplan (HSCT) o
emission-indica ion chemo he apy. The s udy showed
chlo hexidine o be ine ec i e in p e en ing mucosi is.
Also, Rae he and colleagues did no suppo he use o
chlo hexidine mou hwash o he p e en ion o muco-
si is in pa ien s wi h bone ma ow ansplan a ion, and
hey ound ha he e was no signi ican di e ence in
he se e i y o o al ulce a ion be ween he chlo hexidi-
ne and placebo g oups (22-24). Howe e , he e a e s u-
dies ha suppo p ophylac ic use o 0.12% chlo hexidi-
ne glucona e o educe he equency o o al mucosi is
and o al pa hogens in child en wi h Acu e Lymphoblas-
ic Leukemia unde going an ineoplas ic chemo he apy
(25,26). The p e en i e o al p o ocol using chlo hexi-
dine mou hwash can educe bo h he incidence and he
se e i y o o al lesions in child en su e ing om leuke-
mia ecei ing chemo he apy, acco ding o hese s udies
(25).
Ne e heless, i can be sugges ed om he da a p e-
sen ed he e ha chlo hexidine may play a pa in edu-
cing o al damage du ing adio-chemo he apy, possibly
h ough plaque con ol and a educ ion in he o al mi-
c o lo a (26,27). The e was no di e ence in mucosi is
be ween he g oups al hough bac e ial and ungal in ec-
ions we e ound sligh ly less o en among he pa ien s
using chlo hexidine. Howe e , i canno be ansla ed
in o a educ ion in he pain p oduced by mucosi is. The-
se esul s a e in acco dance wi h hose published wi h
chlo hexidine mou hwash (21).
Nowadays, nume ous s udies can be ound abou he
ea men o he p e en ion o he mucosi is wi h di e-
en p oduc s. Chlo hexidine mou hwash is a common
p oduc es ed in he ea men o his illness, and no
only in compa ison wi h he placebo. Dodd e al. pu-
blished some s udies in which chlo hexidine was com-
pa ed wi h s e ile wa e (28) and ano he s udy in which
a solu ion o Lidocaine, Benad yl, and Maalox (29) was
he objec o compa ison. No di e ences in he se e i y
o mucosi is we e ound be ween he g oups in hose
s udies. Howe e , he e was a dec ease in he numbe o
mic oo ganisms in he CHX g oups compa ed wi h he
con ol g oups (30).
Chlo hexidine has been also compa ed wi h benzyda-
mine hyd ochlo ide o al inses o he p e en ion and
ea men o i adia ion mucosi is in pa ien s wi h head
and neck cance (3). Signi ican di e ences we e no de-
ec ed be ween g oups on ou come measu es; a end has
eme ged owa d a lessening o o opha yngeal mucosi-
is o pa ien s who ecei ed benzydamine compa ed o
pa ien s who ecei ed chlo hexidine (3). Howe e , hese
esul s con as wi h hose published by Cheng, who s a-
ed ha om he pa ien s’ pe spec i e, chlo hexidine is
mo e help ul han benzydamine in educing mucosi is
and pallia ing o al discom o (31).
O he p oduc s ha e been es ed o he p e en ion
and ea men o o al mucosi is like zinc-con aining
mou hwash (25) o amine-s annous luo ide solu ion
(32). None o hese inses ha e shown clea ad an ages
o e chlo hexidine so he e is s ill no ea men o his
complica ion o he ea men o head and neck cance .
Cu en ly, he e is no e ec i e he apy o esol e o
subs an ially imp o e he symp oms o mucosi is al-
eady es ablished (9), al hough ecen s udies show ha
he use o a low ene gy lase can be a p omising he apy
(33,34).
� should be poin ed ou ha he esul s o he p esen
pilo s udy should be in e p e ed wi h cau ion due o
he educed sample size. Ne e heless, i seems ha in
ag eemen wi h he e idence indica ing ha chlo hexi-
dine inse is no use ul o he p e en ion and ea men
o he mucosi is induced by chemo adio he apy o head
and neck cance (27,30), he applica ion o gel bioadhe-
si e o chlo hexidine wi h he same in en ion has he
same use ulness.
In ou opinion, u he s udies will be equi ed o ind a
ea men di e en om he chlo hexidine ( inse o gel)
o mucosi is and imp o e he quali y o li e o pa ien s
unde going chemo adio he apy.
Conclusions
�n his double-blind, andomized pilo s udy, he gel bio-
adhesi e o chlo hexidine 0.2% has no p o ided be e
clinical esul s han a placebo on pain and discom o in
he o al mucosi is caused by chemo adio he apy in he
ea men o head and neck cance .
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