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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.