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Esthetic Dentistry
Braz Oral Res 2009;23(Spec Iss 1):64-70
64
Over-the-counter whitening agents:
a concise review§
Abstract: Tooth discoloration is commonly found in the dental clinic and
tooth bleaching has been considered the preferred esthetic alternative,
being more conservative, safe and with predictable results. Supervised
home-use of 10% Carbamide Peroxide (CP) bleaching with custom-trays
is the most common bleaching procedure dispensed by dentists to their
patients. The good results obtained with this technique stimulated the
ourishing of new products and techniques. Over-the-counter (OTC)
bleaching products appeared as a low-cost alternative to bleach discol-
ored teeth without dentist supervision. Different OTC products are avail-
able in supermarkets, drug stores or on the Internet, including rinses,
paint-on brushes, toothpastes, chewing guns, dental oss, and whitening
strips. There is lack of clinical evidence regarding the safety and effec-
tiveness of these products, being most of the studies supported by the
manufacturers’. Basically, toothpastes, chewing gums, and dental oss
are removal agents of supercial stains. Rinses and paint-on brushes with
low levels of hydrogen peroxide have some whitening effect, but without
clinical relevance. Strips present similar esthetic results and side-effects,
compared to bleaching with 10% CP using trays; however, the studies
have nancial support from the manufacturers and were based on short
term evaluations. Legislation varies widely in different countries regard-
ing OTC dental bleaching. Concerns have appeared due to the potential
abusive use of these self-medication agents, especially in young patients,
with potential harmful results. Dentists should be acquainted with this
kind of products to be able to inform their patients. In conclusion, there
is a need for independent clinical trials to provide sufcient evidence re-
garding the use of OTC bleaching products.
Descriptors: Tooth bleaching; Over-the-counter drugs; Peroxides;
Review.
Flávio Fernando Demarco(a)
Sônia Saeger Meireles(b)
Alexandre Severo Masotti(c)
(a)
PhD, Associate Professor, Depar tment of
Operative Dentistry, School of Dentistry,
Federal Universit y of Pelotas, Pelotas, RS,
Brazil.
(b)
PhD, Adjunct Professor, Department of
Operative Dentistry, School of Dentistry,
Federal Universit y of Paraíba, João Pessoa,
PB, Brazil.
(c)
PhD, Adjunct Professor, Department of
Semiology and Clinic, School of Dentistry,
Federal Universit y of Pelotas, Pelotas, RS,
Brazil.
Esthetic Dentistry
Corresponding author:
Flávio Fernando Demarco
Faculdade de Odontologia – Programa de
Pós Graduação em Odontologia
Rua Gonçalves Chaves, 457 - Centro
Pelotas - RS - Brazil
CEP: 96015-560
E mail: ffdemarco@hotmail.com
Received for publication on Nov 18, 2008
Accepted for publication on Dec 05, 2008
§
Paper presented at the “Oral Health
Self-Care Products: Realities and My ths”
international symposium, sponsored by
the Brazilian Association for Oral Health
Promotion (ABOPREV ), September 25-27,
2008, São Paulo, SP, Brazil.
Demarco FF, M ei rel es SS, Masotti AS
Braz Oral Res 2009;23(Spec Iss 1):64-70 65
Introduction
Esthetic dentistry has received increased atten-
tion in recent years, especially due to the fact that
people are more concerned about the esthetic ap-
pearance of their smile. This fact, associated with
the decrease in the incidence and severity of caries,
has directed the clinician’s attention to conservative
and non-invasive treatments, like tooth bleaching.
Tooth discoloration can be inuenced by a com-
bination of intrinsic and extrinsic factors. Intrinsic
stains are related to enamel and dentin properties,
while extrinsic stains are associated to deposition of
either food or beverages stains on the tooth surface.1
A number of methods are available to improve the
color of teeth such as whitening toothpastes, profes-
sional stain removal, enamel microabrasion, vital
tooth bleaching, non-vital tooth bleaching, crowns
and veneers.2
Dentist-supervised home-use tooth bleaching
with custom trays is the most common bleaching
procedure dispensed by dentists to their patients.3
Usually, this treatment modality consists in the ap-
plication of 10% carbamide peroxide in a tray that
is worn at night for at least two weeks. This con-
centration is more accepted than others, due to ex-
cellent esthetic results and low incidence of side ef-
fects.3-5 The most common adverse effects reported
for at-home bleaching systems are tooth sensitivity
and gingival irritation, which disappear when the
bleaching treatment is stopped or an agent like po-
tassium nitrate or sodium uoride is applied.3 Until
now, only the 10 ± 1% carbamide peroxide concen-
tration received the seal of acceptance by the Ameri-
can Dental Association (ADA), which assures its
safety and efcacy for at-home tooth bleaching.6
The benets achieved with bleaching systems
with trays associated with the consumers’ and pa-
tients’ needs have stimulated the marketing of over-
the-counter (OTC) products for at-home tooth
bleaching. OTC products appeared in the USA in
the beginning of the 2000s, as an alternative to treat
tooth discoloration with lower cost than traditional
professional-prescribed/guided products.7 The pro-
liferation of these OTC products in the USA was
in a certain way stimulated by the Food and Drug
Administration (FDA). According to the FDA, these
products could reduce inequity in the access to the
health system, reducing the cost of treatments.8
Currently, gels, rinses, gums, dentifrices, whit-
ening strips or paint-on lms3,6,9 with low levels of
carbamide or hydrogen peroxide are widely available
to consumers at pharmacies, supermarkets and over
the Internet.2 However, these self-applied bleaching
treatments can be harmful and the results may not
be as good as those offered by dentist-guided treat-
ments. Additionally, there is a lack of clinical trials
that provide substantial scientic background re-
garding these whitening products. Thus, this review
evaluates and discusses the current knowledge con-
cerning efcacy, mechanism of action, and legisla-
tion of the OTC tooth-bleaching products.
Critical assessment of the OTC
products for home-use bleaching
In this session, the data related to composition,
mechanism of action, efcacy and side effects of
OTC products available for home-use bleaching are
discussed.
Whitening dentifrices
Toothpastes that claim to have tooth-whitening
properties represent more than 50% of the OTC
products and rarely contain carbamide or hydro-
gen peroxide, or any other kind of bleaching agent.9
Their stain-removal ability is related to the large
quantity of abrasives in their formulation, which
remove supercial extrinsic stains.10 The active
components of tooth whitening dentifrices include
enzymes that break down the organic molecules of
biological lm. Additionally, abrasives such as alu-
mina, dicalcium phosphate dihydrate and silica are
also present in the formulation to promote stain-re-
moval.1 However, the toothpaste abrasiveness needs
to be moderated in order to prevent excessive wear
to the underlying enamel and dentine.11
A number of studies have been published to mea-
sure changes in tooth color after regular whitening
toothpaste use.10-12 Generally, when whitening den-
tifrices are compared to non-whitening toothpastes
the results have demonstrated that their use can re-
move and/or prevent extrinsic tooth stains.1,10,13,14
Although whitening toothpastes can prevent ex-
Over-the-counter whitening agents: a concise revie w
Braz Oral Res 2009;23(Spec Iss 1):64-70
66
trinsic tooth stains, the whitening effect obtained
seems not to be clinically signicant. A study that
compared the efcacy and safety of three OTC
bleaching products (1% hydrogen peroxide denti-
frice, 18% carbamide peroxide paint-on gel, and
5% carbamide peroxide tray system) showed that
the group treated with the tray system experienced
the greatest color improvement. After 14 days of
use, the paint-on gel and dentifrice groups did not
result in signicant color improvements from base-
line. Moreover, tooth sensitivity and oral irritation
were the most common safety ndings in the tray
and dentifrice groups.12 Another study evaluated the
efcacy and safety of a paint-on gel (18% carbamide
peroxide), a whitening strip (6% hydrogen perox-
ide), and a whitening dentifrice. The authors also
observed that there were no signicant differences
in color improvement for the group treated with the
whitening toothpaste compared to baseline.15
Rinses
Whitening mouthrinses appeared recently in
the market and manufacturers advertised that they
could prevent stains and ght plaque build-up. Gen-
erally, a low concentration of hydrogen peroxide
(1.5%) is present and sodium hexametaphosphate
can also be included in the formulation to protect
the teeth surface from new stains. A study evaluated
the efcacy and safety of a whitening mouthrinse
(2% hydrogen peroxide) and whitening strips (10%
hydrogen peroxide) that were used twice daily dur-
ing 1 week. The results showed that although both
products had been well tolerated, the group treated
with the whitening strips experienced a signicantly
greater tooth color improvement than the whiten-
ing mouthrinse group.16 It is necessary, however, to
be careful with self-applied whitening products that
contain peroxide since they have the potential to
produce oral irritation and tooth hypersensitivity.6
Whitening dental floss and toothbrushes
Recently, manufacturers of oral care products
have developed other methods with alleged whit-
ening properties. Whitening dental oss has been
introduced to promote stain reduction around the
interproximal and sub-gingival areas. The stain-re-
moval properties are associated with the presence
of silica in the composition, which promotes a su-
percial surface abrasion during application in the
interdental region. However, no clinical report is
available comparing its effectiveness in relation to
non-whitening dental oss.
Besides being used in a home oral hygiene rou-
tine, manual or power toothbrushes can also be
used to maintain the whitening effect or prevent
extrinsic stains after bleaching treatments. A clini-
cal study compared the ability of two toothbrushes
(power or manual) to maintain the color of whit-
ened teeth after an at-home bleaching treatment
with 15% carbamide peroxide. After 6 months, the
post-bleaching results demonstrated that the power
toothbrush group showed a better ability to main-
tain the whitening effect than that of the manual
toothbrush group.17
Chewing gum
Chewing gum with sodium hexametaphosphate
(4.0 - 7.5%) has been introduced as an OTC prod-
uct for home-use bleaching claiming to prevent ex-
trinsic tooth stain formation. A study showed that
a chewing gum containing hexametaphosphate
reduced stain formation compared to a non-gum
treatment.18 However, when comparing the stain re-
moval ability of two medicated chewing gums con-
taining nicotine with a whitening chewing gum, it
could be observed that the former were more effec-
tive in the removal of extrinsic tooth stains than the
whitening chewing gum.19
Paint-on gels
Paint-on gels or varnishes are OTC barrier-free
whitening products that present hydrogen or carb-
amide peroxide in a suspension that is brushed by
an applicator over the tooth surface and which ad-
heres to enamel.20
A study compared the effectiveness of a paint-
on gel (18% CP), a whitening strip (6% hydrogen
peroxide) and a placebo (uoride toothpaste). The
strip system was found to produce signicantly
greater lightening than the paint-on gel or placebo,
and there was no signicant difference between the
paint-on and placebo groups.21 The low whitening
Demarco FF, M ei rel es SS, Masotti AS
Braz Oral Res 2009;23(Spec Iss 1):64-70 67
effect presented by paint-on gels could probably be
related to the reduced contact time of the whitening
agent with the enamel surface.
Another study compared in vitro the effective-
ness of four paint-on gels (10% CP, 19% sodium
percarbonate, urea peroxide, and 8.7% hydrogen
peroxide) dispensed for home-use bleaching with
a control group (articial saliva). The Vita Shade
Guide results demonstrated that the groups treated
with hydrogen peroxide (5.50 ± 2.15 units) or so-
dium percarbonate (5.60 ± 1.84 units) presented the
greatest color change, while the CP (3.8 ± 1.8 units)
and urea (4.37 ± 1.89 units) groups did not light-
en the color of teeth signicantly after two weeks
of bleaching regimen.20 The results of this study,
however, may be an overestimation of the efcacy
of these products since the teeth were wrapped in
gauze impregnated with an articial saliva solution.
In an oral environment, dilution and rubbing effects
over the paint-on whitening agent would occur to a
greater extent.
OTC tray with gel activated by light
A new product has become available recently in
drug stores or on the Internet, consisting of a univer-
sal tray that can be adapted by the individual him-
self. This tray then receives a gel that is activated by
a compact LED unit. The manufacturer claims that
the bleaching effect is similar to that of a supervised
at-home bleaching with a tray, but it does not clarify
what is the active ingredient. It should be empha-
sized that light activation does not seem to be neces-
sary to increase or accelerate the bleaching process.22
Furthermore, a tray with adaptation problems may
cause soft oral tissue damage, occlusal problems
and/or poor adhesion to the treatment.6
Whitening strips
These products were created aiming to avoid the
use of trays. Adhesive strips containing bleaching
agents are bonded to the anterior teeth, and they
release the active ingredient during relatively short
time periods (5 to 60 minutes), once or twice a day.
The active ingredient is hydrogen peroxide (HP) in
low concentrations (5 to 14%).7 Studies have dem-
onstrated that there is an increase in the whitening
effect when the strips are used for 28 days compared
to 14 days, and that the whitening effect could be
maintained for 2 years.23
In a recent systematic review, when whitening
strips were compared to the ADA recommended
bleaching protocol, i.e. 10% CP in a tray, a simi-
lar bleaching effectiveness was observed. However,
tooth sensitivity was more pronounced than that
observed when the trays were used. It was also ob-
served that strips with higher concentrations (14%)
of HP increased both the whitening effect and the
side effects when compared to strips containing 6%
of HP.3 It should be kept in mind that the 10% carb-
amide peroxide gel contains a 3.3% HP proportion,
almost half of the 6% concentration found in the
strips, but a greater volume of gel is placed in the
tray as compared to the amount of active ingredient
present in the strips.23
Due to the easy method of application, relatively
low cost and good esthetic results, the use of strips
has become an increasingly popular treatment in
the USA.23 For example, while dental centers were
popularizing expensive bleaching techniques, with
the price of a professionally brightened smile in the
400 dollars range, consumers also had the choice of
whitening toothpastes that cost from 2 dollars to 8
dollars, but with a low whitening effect, and Procter
& Gamble successfully targeted a new mass market
with its 35-dollars Whitestrips.24
Considering the pertinent literature, is there
enough scientic evidence in relation to the effec-
tiveness of OTC bleaching products? The systematic
review performed by Hasson et al.3 (2006), showed
that from the 416 clinical trials identied, only 25
could t in the inclusion criteria and most of the
included studies presented bias as a result of short-
term evaluations and nancial support from the
manufacturers. The authors concluded the review
emphasizing the need for independent, long-term
clinical trials to offer evidence about the effective-
ness and safety of the OTC products.
It is important to highlight that a value of 4.0
unit gains using a shade guide has been considered
to be clinically signicant5, and the majority of the
OTC bleaching products, but the strips, will pro-
duce color improvements lower than this value.
Over-the-counter whitening agents: a concise revie w
Braz Oral Res 2009;23(Spec Iss 1):64-70
68
Organizations’ safety
guidelines of OTC products for
home-use bleaching
The legislation permitting the commercializa-
tion of OTC bleaching products in the USA created
a US$ 38 million market in 2001, which increased
10 times until 2005 (US$ 351 millions). At the same
time, products for in-ofce bleaching or at-home
supervised bleaching originated US$ 2 billions in
sales in 2005, having increased four times when
compared to 2000. These values are good enough
to stimulate companies to invest more in this grow-
ing market. Pharmaceutical companies usually in-
vest twice in marketing compared to the resources
invested in research, which bring about a poten-
tially risky situation: abusive usage of drugs by in-
sufciently informed consumers.25 This situation
is more complicated in countries like Brazil, where
self-medication is a common practice. Economic,
political and cultural factors can contribute to the
growth and spreading of self-medication, including
great availability, irresponsible publicity, pressure to
convert prescription-only drugs in over-the-counter
products, quality of health care and difcult access
to health services, especially in poor countries.26 De-
spite some recommendations indicating bleaching
treatments for patients aged 15 years and above,9
studies have been performed in patients with ages
as early as 9 years.23 Young patients (children and
teenagers) are strongly susceptible to the irrational
use of medications26 and this should be kept in mind
when indicating OTC bleaching products.
European legislation (Scientic Committee on
Cosmetic Products and Non-Food Products Intended
for Consumers) regarding the use of HP products has
highlighted that products containing 0.1 to 6% HP
are safe only when administered under professional
supervision, and more long-term clinical evaluations
should be conducted to evaluate these products.6, 27
As to the US government position, the FDA clas-
sies HP products as OTC products, based on the
current scientic literature showing no contraindi-
cation for this kind of products, without the need of
professional supervision. However, the FDA points
out the risk for potential abusive use of these OTC
bleaching products, which are used by one in each
four American teenagers.8 ,28 More cautious, the
ADA (American Dental Association) has reported
the OTC products to be benecial to the public, but
when used under dentist supervision.5
The ADF (Association Dentaire Française), in a
comprehensive literature review concerning bleach-
ing procedures, emphasized that OTC products
should be classied as medical devices, instead of
cosmetics, especially due to the crescent overuse.
The ADF committee concluded that when bleaching
agents are repetitively used without supervision and
without real motivations, this must be considered
a public health problem. In addition, it has recom-
mended that bleaching agents be used in a reservoir
to avoid deglutition, thus preventing potential haz-
ardous problems.9 Safety concerns emerge in rela-
tion to the abusive use of OTC products, taking into
account that nowadays younger patients are looking
for bleaching procedures.7,2 3
In relation to carcinogenesis, high hydrogen
peroxide concentrations may act as a promoter of
oral lesions together with other known carcinogenic
products (tobacco, alcohol), but low concentrations
of carbamide peroxide are considered to be safe, and
some recommendations should be directed to pa-
tients and clinicians, such as to protect the oral soft
tissues when applying high HP concentration agents
(in ofce bleaching), to use low concentration agents
and for short periods of time.6 Care should also be
taken to avoid deglutition of peroxide agents.
Regarding the Brazilian regulations, all bleach-
ing products are considered to be cosmetics (Degree
II), being subject to regulations similar to those of
toothpastes containing uoride. Thus, an individual
can easily buy bleaching agents, without any re-
striction, as long as they are registered in the Na-
tional Sanitary Survey Agency (Agência Nacional
de Vigilância Sanitária – ANVISA). Moreover, the
advertisement regulations are more lax when OTC
products are considered as cosmetics instead of
medical devices.29
Thus, it is not unlikely that Brazil may present
the same abusive misuse of bleaching products, sim-
ilarly to what is currently observed in the USA, in a
phenomenon called “bleachorexics” or “whitening
junkies”.30 Since 35% of the medication used in Bra-
Demarco FF, M ei rel es SS, Masotti AS
Braz Oral Res 2009;23(Spec Iss 1):64-70 69
zil is self-medication,25 information is of utmost im-
portance, and dentists should be aware of the risks
posed by the abusive use of OTC bleaching prod-
ucts. A possible reclassication of these products by
the ANVISA should also be discussed.
Conclusions
Based on the present literature review, the fol-
lowing conclusions may be drawn:
Whitening toothpastes, whitening dental oss, 1.
and pro-whitening toothbrushes are supercial
stain removing agents, and not bleaching agents
per se.
Paint-on gels and rinses have lower levels of 2.
bleaching agents and may produce a whitening
effect that does not seem to be clinically signi-
cant, as observed by the small number of clinical
trials available.
Whitening strips seem to produce a whitening ef-3.
fect similar to that of 10% CP in a tray, but the
clinical studies reviewed were generally based on
short-term evaluations and were performed with
the manufacturers’ nancial aid.
Independent, long-term clinical trials should be 4.
performed to evaluate the effectiveness and side
effects of OTC bleaching products.
Legislation varies largely among different coun-5.
tries, and clinicians should be acquainted with
the available products and be aware of the po-
tential abusive self-medication use of OTC prod-
ucts, which could produce harmful effects.
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