| Introduction
Plaque is the major contributing factor to dental caries
and periodontal disorders. As part of good oral hygiene
measures, toothpastes play an important part in disease
prevention. In addition to flavoring, toothpastes basically
contain detergents and polishing agents. Additionally,
toothpastes may contain additives for particular benefits,
such as anticaries or antimicrobial effect or inhibition
of the formation of tartar.1 Active agents commonly
incorporated in dentifrices include Chlorhexidine, Triclosan
(Antimicrobial); Potassium Nitrate and Stannous Fluoride
(Desensitizers); Sodium Fluoride, Sodium Monofluorophosphate,
Acidulated phosphate Fluoride (Anti-cariogenic). According
to the International Standards Organization these dentifrices
are categorized as 'medicated' and defined as, "any
dentifrice containing or claimed to contain ingredients
having a beneficial, preventive or therapeutic action
on oral tissues".2
Corticosteroids have limited use in the routine management
of oral disease. At best, they are indicated in conditions
not amenable to other measures and drugs. Steroids are
known for their 'masking effects' and their abuse is
documented in a previous study in the country.3 Their
incorporation in some dentifrice brands was suspected
from anecdotal reports of quick, symptomatic, relief
from inflammatory diseases like gingivitis and periodontitis.
Further, some toothpaste brands claim to 'cure' all
diseases of teeth and gums without listing the active
therapeutic ingredients on the label. Since toothpaste
is not included in the list of items under compulsory
monitoring by the Pakistan Standard and Quality Control
Authority4, manufacturers are not legally bound to follow
Pakistan Standards Institution's specifications for
toothpastes.5 We have not been able to find any reference
in the international literature to the incorporation
of steroids in over -the -counter dentifrices. In view
of this possibility we decided to test some of these
proprietary products for the presence of steroids.
Materials and Methods
One tube each of twenty locally marketed toothpaste
brands, claiming therapeutic value in oral and dental
problems, and thus falling into the category of medicated
dentifrice, were purchased from a major store. These
samples were tested for steroid at the Pakistan Council
of Scientific and Industrial Research (PCSIR) Laboratories.
The standard protocols of British Pharmacoepia6 were
followed in carrying out qualitative and quantitative
tests for the presence of steroid. In order to avoid
the possibility of batch contamination fresh samples
of those brands that tested positive were purchased
from another store in an entirely different area of
the city after a gap of four months and submitted for
re- testing. Samples that tested negative for steroid
in the first test were excluded.
Results
Eight out of twenty brand samples tested positive for
the presence of steroid (cortisone). Both qualitative
and quantitative tests were done on seven of the brands.
(Quantitative test on one steroid-positive brand-sample
was not done). In the second qualitative test of these
eight samples, seven were found to contain steroid.
(Table 1). The remaining twelve brands that were negative
for steroid initially were not re- submitted for second
analysis. (Table 2). The brands, purchasing date and
date of reporting by the PCSIR are listed in the tables.
Discussion
According to the International Standards Organization
(ISO) a medicated dentifrice is defined as, "any
dentifrice containing or claimed to contain ingredients
having a beneficial, preventive or therapeutic action
on oral tissues".7 In the specifications for toothpaste
standards by the Pakistan Standards Institution there
is no reference regarding medicated dentrifices.5 Our
review of the standards for toothpastes made by neighboring
countries of India and Sri Lanka showed special mention
of the same. Clause 2.2.4, regarding composition of
toothpastes in the Sri Lankan standard states, "any
other substance
done on seven of the brands. (Quantitative test on one
steroid-positive brand-sample was not done). In the
second qualitative test of these eight samples, seven
were found to contain steroid. (Table 1). The remaining
twelve brands that were negative for steroid initially
were not re- submitted for second analysis. (Table 2).
The brands, purchasing date and date of reporting by
the PCSIR are listed in the tables.
Discussion
According to the International Standards Organization
(ISO) a medicated dentifrice is defined as, "any
dentifrice containing or claimed to contain ingredients
having a beneficial, preventive or therapeutic action
on oral tissues".7 In the specifications for toothpaste
standards by the Pakistan Standards Institution there
is no reference regarding medicated dentrifices.5 Our
review of the standards for toothpastes made by neighboring
countries of India and Sri Lanka showed special mention
of the same. Clause 2.2.4, regarding composition of
toothpastes in the Sri Lankan standard states, "any
other substance whose therapeutic or prophylactic functions
have been clinically established may be used".8
Indian Standard for toothpaste, in its foreword, categorically
states that medicated toothpastes (which are produced
under drugs license) claiming therapeutic value to teeth
and gums such as control of plaque and tartar are not
covered.9 According to Medicines Control Agency of the
United Kingdom, toothpaste is generally considered as
a cosmetic, but if it is marketed with claims to treat
or prevent "sensitive" teeth or contains an
active ingredient known to have such an effect then
it would fall within the definition of a medicinal product
and be subject to medicines control.10 In Pakistan no
specific standard or regulations exist under which production
and marketing of medicated dentifrices can be regulated.
Toothpastes do not come under the head of compulsory
items of Pakistan Standards and Quality Control Authority,
the manufacturing of which could be monitored.11 There
are no medicated dentifrices produced in Pakistan under
a drugs license granted by the Ministry of Health. It
is left to the discretion of manufacturers to use any
ingredient in any amount.
The adjunctive role of toothpastes in the overall management
of oral health care is well documented.12-14 Epidemiological
studies, based on the tooth surface as a unit of reference,
confirm a strong correlation between dental plaque and
the initiation of dental caries and periodontal disease.
Therefore, prevention of caries and periodontal disease
must be based on plaque control. Dental plaque can be
controlled mechanically and chemically. Dentists and
dental hygienists can achieve both methods in the population
through proper promotion of home self-care and by professional
treatment. Chemical antimicrobial products are used
for non-specific plaque control, as well as against
specific microbes associated with the etiology of caries
and periodontal disease.15 The plaque control product
formulations have been extensively discussed in the
literature.16-19 We were unable to find any reference
in the international literature regarding the use of
steroid compounds or preparations in products labeled
as dentifrices and marketed over the counter.
According to ISO specifications all ingredients (on
the label of toothpaste-brand) shall be mentioned according
to the International Nomenclature of Cosmetic Ingredients
(INCI) Dictionary or with descriptive names of ingredients:
"identification of ingredient shall be consistent
with the dictionary, which states how the declaration
should be made and ingredient identified".20 In
none of the dentifrices that tested positive was steroid
cited as an ingredient. Since this is a pharmacological
agent the product would automatically come into a drug
category requiring prior approval and licensing by the
Health Ministry. This is both expensive and time consuming.
Further, the manufacturers / agents would need to show
documentary evidence from the international literature,
or significant local clinical evidence, of the therapeutic
benefits of that addition. Some of the brands did not
list their ingredients at all.
The finding of illegal, and possibly hazardous, addition
of corticosteroids in dentifrices raises a number of
issues of public interest. First, the role of government
regulatory and monitoring bodies needs to be re-defined
particularly in terms of over- the- counter oral health
products. Products like medicated toothpastes must be
monitored to ensure their safety and verifiability of
ingredients for use in dental diseases. The International
Standard Organization's specifications can be followed
in determining these regulations. Once this is done
it must be monitored periodically and any manufacturer
found to violate the regulations must be made to face
strict punitive measures.
As earlier mentioned, steroids when administered unwarrantably
and irrationally can obscure the true diagnosis of the
inflammatory disease as seen in systemic disorders (e.g.
Rheumatoid Arthritis). Steroids are neither specific
nor curative: instead they provide palliation by virtue
of their anti-inflammatory and immunosuppressive actions.21
The quick relief of symptoms of pain, swelling and bleeding
gums, by the unknowing use of steroid containing dentifrices,
entices people to re-use that brand whenever symptoms
recur or exacerbate. This would also be a logical alternative
to an expensive dental consultation. The vicious cycle
continues till a 'ceiling effect' of the amount of steroid
is reached. There are no studies done so far on the
long-term local effects of steroids when applied topically
on gingiva. However the effects on skin are well documented.
With prolonged use side effects will be encountered,
in the form of local atrophy, or as a result of systemic
absorption, for example hypothalamic-pituitary-adrenal
suppression and Cushing's syndrome.22 Its topical use
is also associated with perioral dermatitis.23-25 It
is quite possible that since oral mucosa has far greater
absorptive capacity than skin systemic side effects
may result earlier and with lesser steroid quantities.
Further studies will be needed to confirm confirm this
possible relationship.
The role of advertising agencies and the media in possible
unethical promotion of products and the routine publication
of unverifiable or spurious claims is brought into question
by this study. Pakistan needs to have an equivalent
of the Advertising Standards Authority, an international
watchdog body, whose functions include the monitoring
of ethical advertising. The claims of some of these
products to cure most dental diseases are not only grossly
misleading but also fraudulent. Such claims are commonly
propagated to the detriment of unsuspecting, often uneducated
and mostly poor, people. Instead of educating people
about the real causes of dental problems the media can,
inadvertently, become a major source of misinformation.
Conclusion
A potentially serious health hazard exists by the unknowing
use of steroid containing toothpastes by the public.
Medicated dentifrices must only be manufactured and
marketed under license and the Advertising Standards
Authority needs to investigate questionable claims and
ethically approve such proposals before they are completed
and readied for release. On the part of the government
and the health authorities there is an urgent need for
appropriate legislation and implementation to make sure
that such products do not reach the market.
Acknowledgement
Funding for the testing of samples by the PCSIR in
this study, was provided by the Fatima Jinnah Dental
College as part of a grant for research projects undertaken
during FCPS II training.
Refrences
1. Stadtler P, Holler H. Toothpastes. Int J Clin Pharmacol
Ther Toxicol 1992;30: 167-72.
2. ISO 1942-1: 1989, Amd.3. International Standards
Organization, 1993; 2-3.
3. Farooqi AZ, Nasimuddin, Aman R, et al. Corticosteroid
use and abuse by medical practitioners for arthritis
and related disorders in Pakistan. Br J Rheumatol 1997;36:
91-4.
4. Pakistan Standards and Quality Control Authority,
Act 6, Gazette Notification, Government of Pakistan
1966. [Since toothpaste is NOT included in the list
of compulsorily monitored products there is no page
referral].
5. Pakistan Standard: 1721. Pakistan Standards Institution
1985;1-25.
6. British Pharmacoepia. Vol.1, 1993; 187-88.
7. ISO 1942-1: 1989 Amd.3. International Standards
Organization 1993: 3-4.
8. SLS: 275. Standards Institute of Sri Lanka 1974;
2.2.4.
9. IS: 6356. Bureau of Indian Standards 1993. Foreword.
10. Medicines Control Agency UK. Borderline products
[online] (Article 1 or Directive 65/65 EEC 2000) [cited:
Aug 25, 2002]. http://www.mca.gov.uk/ourwork/licensingmeds/whatis/whatis.htm
11. Compulsory items for home market and thir SSRO'S:Pakistan
Standards and Quality Control Authority. Dec. 2001;1-2.
12. Sheen S, Pontefract H, Moran J. The benefits of
toothpastes - real or imagined? The effectiveness of
toothpaste in control of plaque, gingivitis, periodontitis,
calculus and oral malodour.dent Update, 2001;28:144-7.
13. Forward GC. Role of toothpastes in the cleaning
of teeth. Int Dent J 1993;43:473-82.
14. Addy M, Koltai R. Control of supragingival calculus:
scaling and polishing and anticalculus toothpastes:
an opinion. Clin Periodontol 1994;21:342-6.
15. Axelsson P. Current role of pharmaceuticals in
prevention of caries and periodontal disease. Int. Dent
J 1993;43:473-82.
16. Forward GC, James AH, Barnett P, et al. Gum health
product formulations: what
is in them and why? Periodontology, 2000. 1997;15:32-9.
17. Pader M. Recent advances in dentifrices. Cosmetic
Toiletries 1992;107:63-70.
18. Wilkinson JB. Efficacy of dentifrices - formation
and evaluation. Cosmetic Toiletries 1982;97:45-8.
19. Marsh PD. Dentifrices containing new agents for
the control of plaque and gingivitis: microbological
aspects. J Clin Periodontol 1991;18:462-7.
20. ISO 11609 (E): International Standards Organization
1995;1-3.
21. Hardman JG, Limbird LE, Gilman AG (eds). In: Goodman
and Gilman's, The
pharmacological basis of therapeutics. 10th ed. New
York McGraw-Hill, 2001, p. 1649.
22. Barnetson RS, White AD. The use of corticosteroids
in dermatological practice. Med J Aus 1992;156:428-31.
23. Guin JD. Complications of topical hydrocortisone.
J Am Acad Dermatol
1981;4:417-22.
24. Weber G.Perioral dermatitis, an important side
effect of cirticosteroids.
Dermatologica 1976;152 (Suppl 1):161-72.
25. Morman MR. Possible side effects of topical steroids.
Am Farm Physician 1981;23:171-4.
back |
