oral hygiene products
DESCRIPTION
PDF, Classification, Toxicity & Biocompatability , Allergies, Mutagenicity & Teratogenicity,TRANSCRIPT
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ORAL HYGIENE PRODUCTS
Presented by:
Dr. Hashmat Gul,
Demonstrator,
AMC, NUST,
Dental Materials.
1. INTRODUCTION
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INTRODUCTION�CLASSIFICATION OF ORAL HYGIENE PRODUCTS
� Oral Hygiene Products include
� Tooth pastes
� Mouth washes
� Tooth Bleaching Agents
� Fluoride Varnishes And Gels
� There is no clear Borderline Cosmetic/Dental Material.
THE AIM OF THIS CHAPTER
�To review compatibility or potential side effects of oral hygiene products.
� To provide adequate information to patients.
� To facilitate diagnosis of side effects & assignment of symptoms to possible
causes.
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2. TOOTHPASTES & MOUTHWASHES
COMPOSITION
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Abrasives Foaming agents Binding agents Humectants Flavourings
� Silicon dioxide,� Calcium carbonate,� Aluminium
trihydrate,� Trisodium
phosphate
� Sodium Lauryl Sulfate,� Cocosamidepropylbetaine� Triton-X 100,� Calcium glycero-
phosphate,� Stearyl etoxylate
� Carboxymethylcellulose� Xantham gum,� Silica gel,� Cellulose gum,� Hydroxyethylcellulose� Carbopol (carbomer)
� Glycerol,� Polyethylene glycol,� Propylene glycol
� Saccharin,� Sorbitol, � Xylitol,� Peppermint oil,� Anise oil,� Menthol,� Eucalyptol
Antimicrobials Colorants Preservatives Anti-calculus
agents
Fluoride salts
� Chlorhexidine,� Triclosan
� Titanium dioxide,
� Azulene
� Methyl-p-hydroxybenzoats,
� Ethanol
� Tetrasodium-pyrophosphate,
� Disodium azacycloheptanediphosphonate
� Sodium fluoride, � Sodium monofluorophosphate� Stannous fluoride, � amine fluoride� (bis-(hydroxyethyl-)-aminopropyl-N-
hydroxyethyloctadecylaminedihydrofluoride)
COMPOSITION
2.1. SYSTEMIC TOXICITY
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ACUTE SYSTEMIC TOXICITY
Toothpastes/Mouthrinses
Normal use
No Acute Systemic Toxicity
Ingestion by Children
Intoxication & poisoning
Alcohol
Alcohol induced hypoglycaemia
Irreparable damage to the liver and brain
Death in severe intoxication
Fluorides
No fatality due to controlled Package size
ALCOHOL TOXICITY
�INCIDENCE 168 exposures per 100,000 children under 6 years of age.
�SAFETY PRECAUTIONS
�The American Dental Association
� Child-safe bottle tops.
� Warning (mouthwashes >5% alcohol).
�The American Academy of Pediatrics Recommended to the U.S. Food And Drug Administration
That over-the-counter (OTC) products should
� Limited alcohol content of 5% v/v to the most.
� Child-safe bottle tops.
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FLUORIDES TOXICITY
�The Probable Toxic Dose (PTD) of fluoride, 5 mg F/kg of body weight.
�In Europe, the Maximum Permitted Concentration of Fluoride in toothpaste for
�OTC sales 0.15%
�Pharmacies 1.3%
�SAFETY PRECAUTIONS
� Package size & especially, fluoride contents be controlled.
� Supervised toothpaste use by preschool children
�Manufacturers should be encouraged to include this advice in labels.
CHRONIC SYSTEMIC TOXICITY
Dental Fluorosis
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� FLUORIDES IN TOOTHPASTES
Chronic Systemic Toxicity
Dental Fluorosis
“Low fluoride” toothpastes for small children with fluoride concentrations from 0.025% to 0.05%.
Elevated levels of fluoride concentrations in plasma and urine after toothpaste use observed.
Osteofluorosis
Not likely to occur with normal use of toothpaste/mouthwash
With 8 ppm fluoride in drinking water, only older subjects revealed increased density in their bone structure with no symptoms of illness
Table. Calculated fluoride intake according to age in children using a 1,000-ppm fluoride toothpaste compared with calculated median fluoride dose for children with fluorosis prevalence of 28% who were given fluoride tablets
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�“EPIDEMIOLOGICAL EVIDENCE”
� Use of fluoride toothpaste (mean fluoride concentration 1,000 ppm)
in preschool children may be a risk factor for fluorosis.
Goa Study
• Toothpaste was the only source of fluoride apart from drinking water containing < 0.1 ppm fluoride
• The severity of lesions > who began brushing before the age of 2 years.• Fluoridated toothpaste is a risk factor for dental fluorosis (12.9% prevalence)
Study 2
• In areas with 1.0 mg fluoride per liter of drinking water, • a prevalence of dental fluorosis of 60% is to be expected if drinking water is the sole source of fluoride exposure.
FLUORIDE IN MOUTHRINSES
An extensive study of mouth rinsing capabilities of 474 preschool children
(ages 3–5 years)
• All subjects swallowed a significant portion of a mouthwash.
• If a 0.1% fluoride rinse had been used, Average ingested fluoride,1.2–2.02 mg.
• Fluoridated mouthwashes should not be prescribed for children under 7 years of age.
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2.2. LOCAL TOXICITY AND BIOCOMPATIBILITY
Damage to the hard tissues
• Mechanical abrasion, which is most pronounced in dentine.
• Chemical erosion, which is most severe in the enamel.
Soft tissue reactions
• May occur immediately or• after prolonged exposure
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MECHANICAL ABRASION
�ABRASIVES: Essential component of toothpastes
mechanical removal of stained tooth pellicle.
�Requirements of in vitro study
� Use a relevant substrate (natural teeth, dentine)
� Knowledge of the abrasive compound + Abrasive particle size &
other constituents of the toothpaste.
�The method of brushing( e.g. horizontal brushing)
�The abrasivity of all commercially available toothpastes is generally low
No Clinical Significance.
HARD TISSUE EROSION
�Erosion of enamel is seen after frequent exposure to acidic
solutions (pH 4.0 or less)
�All international standards require that the pH of
� Toothpastes be within the range 4.5–10.0.
� Mouthrinses should not be < 4.0.
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SOFT TISSUE REACTION
�Acute Reactions Of The Oral Soft Tissues To Oral Hygiene Products
� Epithelial Peeling,
� Mucosal Ulceration & Inflammation,
�Gingivitis,
� Petechiae.
�Patients may complain of
� A Burning Or Stinging Sensation,
� Soreness Or Pain,
� Staining Of The Teeth And Tongue,
� Taste disturbances.
SOFT TISSUE REACTION
�CAUSES Detergents & Flavoring Oils
� A direct chemical injury or irritation of the soft tissues,
� Allergic reactions
�Soft Tissue Reaction may be affected by
� The length of time the product is used,
� The frequency of application,
� The Concentrations of the components responsible for
the reactions observed.
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DETERGENTS�Detergents are used because they cause toothpastes to foam when applied (which is a
consumer preference), but they are also useful emulsifiers.
Sodium Lauryl Sulfate (SLS) Stearylethoxylate Cocoamidopropyl betaine
(CAPB)
� Also called sodium dodecyl sulfate. � Most commonly used detergent.� For children toothpastes, 0.5% SLS to reduce “burning”sensation.
� Toxic effects� Denatures Proteins� 7.5% SLS produce inflammation of OM.
� Reduction in keratinization of oral epithelium.
� Epitheliolysis of Oral mucosa.
� Less toxic than SLS in cell cultures ofHuman oral mucosa
� For children toothpastes, Omitted SLS &instead have incorporated a zwitterionic detergent, cocoamidopropyl betaine (CAPB).
• (0.5%, 1.0%, and 1.5%)• 42 Desquamative Reactions.SLS
• (0.64%,1.27%, and 19%)• 3 Desquamative Reactions.CAPB
• No Oral Desquamations
No Detergent
STUDY 1: Detergents & Oral Mucosa Irritation In A Double-blind
Crossover Trial With Toothpastes� The pastes were applied for 2 min twice daily in cap splints for 4 days.
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• Painful Aphtous Ulcerations. SLS
• Significantly Fewer Aphtous Ulcerations.CAPB
• Significantly Fewer Aphtous Ulcerations With Placebo (Detergent-free)No Detergent
• Amelioration Of Aphthous Ulcerations.Stearylethoxylate
STUDY 2: Detergent effect on Recurrent aphthous stomatitis
ALCOHOL
EFFECT 0N ORAL MUCOSA
�Alcohol concentrations of more than 7.5% can result in oral pain sensation, which may be
exaggerated by other ingredients of a mouthwash.
�Mouthwash containing 26% alcohol Hyperkeratosis Of The Oral Mucosa.
�Increased Alcohol concentrations
� > Intensity of Oral Pain.
� > Time required for Cessation of Post-rinsing pain.
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LOCAL REACTIONS TO ANTIMICROBIAL AGENTS
�Chlorhexidine Mouthwash
� Brown discoloration of the teeth and tongue and with altered taste sensation.
� Superficial desquamation of the oral mucosa.
�Benzethonium chloride (0.2%)
� Study 1: Caused desquamative lesions of the oral mucosa in 4 out of 5 subjects
� Study 2: Discoloration of the tongue and around some of the teeth in 8 out of 12
subjects.
�Cetylpyridium chloride rinse burning sensation.
2.3. ALLERGIES
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• 30 allergins identified in toothpastes sold.
• The prevalence of allergic reactions to oral hygiene products is apparently low. e.g. 2% in toothpastes.
• Patients with allergic diseases such as asthma, hay fever, or allergic skin are particularly susceptible.
These patients should be informed about potential allergens in mouthwashes and toothpastes.
IgE-Mediated (Type I) Allergic Reaction Delayed Allergic Reactions (Type IV)
�Urticaria, � Edema, � Erythema,�Occasionally, Vesicle Formation In The Oral Mucosa.
�May occur as late as 24–48 h after contact with the allergen,
�May be seen as � Erythema, �Ulceration, � Epithelial peeling
Types Of Allergy Associated with OHP
ALLERGY TESTING
�Testing for allergic reactions can give
� False negative reactions due to too-low concentrations of the sensitizer.
� False positive reactions due to the contents of detergents, abrasives, etc.
�No need to test the oral mucosa directly.
�Open patch test recommended on the fore arm (detergents & alcohol may cause irritation under a closed patch
test , followed by attempts to define the allergin.
�The services of an experienced dermatologist required.
� Atopic patients comprises about 10% of the population, are characterized by the following:
� Immediate vascular exudative reaction of the skin to specific exciting agents
� A tendency to acquire forms of familial idiosyncrasy such as hay fever
� The presence of increased levels of IgE
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ALLERGENS Allergens in OHP Allergic Reactions
Flavoring Agents
� Cinnamon (cinnamic aldehyde)� Peppermint oil (Menthol)� Spearmint (L-carvone) � Anethole
CHLORHEXIDINE
Other Potential Allergens
� Acetamide, � Azulene,� Benzoates, � Chloro-acetamide, � Di-chlorophene, � Formaldehyde
� Contact urticaria� A Lichenoid Reaction� Allergic Contact Cheilitis� Induced Asthma
� Potential Anaphylactic Responsesparticularly In Japanese Patients.
� Contact Dermatitis
2.4. MUTAGENICITY, CARCINOGENICITY,
AND TERATOGENICITY.
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�Toothpastes, as opposed to tooth brushing, may not be essential
for maintaining oral health.
�PROBABLE HUMAN CARCINOGENS
�Tetra-chloroethylene
�Benzene
�Chlorofom
�Triclosan (Anti-microbial) resistant-strains.
�Relationship of Oral Cancer & Mouthwashes
� Insufficient evidence.
�Regular daily use of alcohol-containing mouthwashes
could contribute to elevated risks of oral cancers among smokers
3. TOOTH BLEACHING AGENTS
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HISTORY
�Removal of intrinsic staining may require chemical agents.
�Various acids such as Oxalic acid and Hydrochloric acid have
been recommended previously.
�For the last 50 years, bleaching of teeth with hydrogen
peroxide (30–35%) or compounds that release hydrogen
peroxide, such as carbamide peroxide and sodium perborate,
have been described as most suitable for bleaching vital and
non-vital teeth
CARBAMIDE PEROXIDE
�Tooth whitener , Carbamide peroxide, a mild anti-septic (also called urea hydrogen peroxide,
perhydrit, hyperol, or perhydrol urea) is an addition complex of hydrogen peroxide with urea,
which has a mild effect on plaque and gingivitis.
�On contact with saliva, carbamide peroxide dissociates to hydrogen peroxide (34%) & urea.
� Haywood and Heymann introduced bleaching of teeth with 10% carbamide peroxide gels
placed in custom-built trays to be worn by patients at night for 2–6 weeks.
�A number of products became available with 10–15% carbamide peroxide gels, not only for
professional use but also in kits with custom-fabricated trays for OTC sales.
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THE SYSTEMIC TOXICITY
�RAT STUDIES
�Whiteners with carbopol in addition to carbamide peroxide have > toxicity than
carbamide peroxide alone. (LD50 87.2 mg/kg body weight versus 143.8 mg/kg body weight).
�Cherry et al. showed that 5,000 mg/kg body weight produces serious lethal symptoms.
�Dahl & Becher showed that 15 mg/kg gave rise to histological changes in the gastric mucosa
that were not seen with 5 mg/kg body weight.
�IN HUMANS
�Dahl and Becher calculated an exposure limit for humans of 10 mg carbamide peroxide per day.
�Carbamide peroxide (10%) as used in bleaching agents delivers 3.5% hydrogen peroxide.
Exposures to 3% hydrogen peroxide (common household strength) are usually benign.
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THE MECHANISMS INVOLVED IN HYDROGEN PEROXIDE POISONING
Gastric catabolism of hydrogen peroxide to oxygen and
water
uptake by the bloodstream
Venous embolism
Cerebral infarction
Stroke
� Successful treatment with hyperbaric oxygen.
LOCAL TOXICITY AND TISSUE COMPATIBILITY
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�In mouthwashes, 3% hydrogen peroxide or 10% carbamide
peroxide is apparently limited.
�Erosive gingival lesions are not normally expected to occur
with limited/occasional use of 3% hydrogen peroxide
mouthwashes.
�Carbamide peroxide bleaching systems sold for home use
are anhydrous and extremely hypertonic and thus might be
expected to produce gingival lesions with prolonged contact.
DENTAL HYPERSENSITIVITY
�to Cold stimuli was reported in an At-home tooth bleaching protocol
with 10% carbamide peroxide.
�30–35% hydrogen peroxide for professional tooth bleaching reported some post-
treatment sensitivity that dissipated with time.
�Greater hypersensitivity observed if enamel is etched prior to bleaching.
�Vital teeth in patients with large restorations, extensive erosions/abrasions of the
cervical tooth surface, or pronounced enamel cracks should be bleached with caution
because increased risk of penetration of potential toxic substances to the pulp.
�Hydrogen peroxide at concentrations of 12% in gels, dentifrices, and mouthrinses is
not carcinogenic, mutagenic, or teratogenic
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4. FLUORIDE VARNISHES & GELS
INTRODUCTION
�History
�Topical Fluoride application done by Professionals for more than half a century.
�But it has become popular in the last 3 decades.
�Topical Fluoride Applications
� Fluoride aqueous solutions by Health Professionals.
� Fluoride gels Use at Home in prefabricated or custom-built trays.
� Fluoride varnishes by Health Professionals only.
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FLUORIDE GELS
TYPES OF FLUORIDES IN
GELS
LOCAL EFFECTS SYSTEMIC EFFECTS
�Sodium fluoride,
�Stannous fluoride,
�Amine fluoride,
�Acidulated phosphate fluoride (APF).
�Disagreeable taste & may stain teeth.
�Acidic taste (pH 3.0) & will etch teeth & Ceramic or Composite restorations.
� For Home Use, Gels usually contain 1.1% Sodium Fluoride or about one-half of the fluoride concentration used in gels for professional application.
� Potential Toxic Dose (PTD) of fluoride
=5mg/kg body weight (average)�A 2-year-old child of 12.3 kg would need to swallow only 5 ml of a 1.23% APF gel to reach the PTD.
STUDIES TO ACCESS FLOURIDE TOXICITY
Spak and colleagues used 3 g of a low-fluoride gel(0.42% fluoride) for a 5-min application in custom trays in 10 adults.
About 40% of the gel was swallowed
Caused gastric injuries in 7/10
subjects, observed at gastroscopy 2 h after application.
Minor clinical significance (Rapid recovery of Gastric mucosa & just 2-4 times application
annually)
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STUDIES TO ACCESS FLOURIDE TOXICITY
Application of gels containing 1.23% or 0.1% fluoride in Children & Adults.
Plasma fluoride levels sufficient to cause a decrease in urinary concentration ability.
One of the adults in this study experienced
gastrointestinal symptoms.
FLUORIDE VARNISHES
ADVANTAGES DISADVANTAGES
� The amounts used are much smaller than for gels.
�Slow Fluoride Release.� Fluoride is in suspension rather than dissolved.�Designed to adhere to the teeth.�Systemic fluoride exposure from varnishes is expected to be lower than for gels.
� The plasma fluoride levels recorded after varnish use were lower by a factor of 10 than those found with fluoride gels.
� Fluoride concentrations in varnishes is much greater than in gels.
�Designed for use by Health Professionals only.
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VEHICLE SUBSTANCES
�The substances used to form the fluoride vehicle in Gels and varnishes.
FLUORIDE SYSTEM VEHICLE SUBSTRATE SIDE EFFECT
�Gels �Cellulose �No Toxicity
�Varnishes � Duraphat
� Neutral Colophonium
�BiFluorid
�a mixture of ethylacetate &isoamylpropionate
� Colophony/Rosin Sensitization rxn.
� Ethyl acetate Non-toxic.� Isoamylpropionate Low toxicity.