COMPOSITION & CHEMISTRY OF DENTIFRICES

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COMPOSITION & CHEMISTRY OF DENTIFRICES

DENTIFRICE:A dentifrice is a substance used with a toothbrush for the purpose of cleaning the accessible surfaces of the teeth (American Dental Association)

TOOTHPASTE:Toothpaste is a colloidal suspension of a mixture of ingredients that must be carefully balanced in order to provide an efficacious, safe, and consumer friendly product

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TOOTHPASTE INGREDIENTS

• Abrasive• Binder• Humectant• Sweetener• Flavor• Surfactant

• Active Ingredients

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ABRASIVE

• Function:– Cleaning and polishing

• Characteristics:– Solid, insoluble particles– Abrasive– Potential for fluoride interaction

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ABRASIVE

• Types :

– Silica– Phosphate Salts – ie “Dical”– Carbonates – ie Calcium Carbonate or Chalk– Others

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Radioactive Dentin Abrasion Method

This procedure involves the use of accelerated toothbrushing apparatus and dentin section that contain radioactive phosphorous. The ADA standard was set at 100, which corresponds to RDA value of 475.

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Figure 7: In-vitro Abrasion Studies, RDA

• This photograph shows a two-brush model abrasion machine, which is used in in vitro dentifrice abrasion studies.

Source: Stallard, Richard E. A Textbook of Preventive Dentistry (Second Edition).

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Comparative Abrasiveness of some Commercially Available Dentifrices as Determined by a Radioactive Dentin Procedure

Source: Stallard, Richard E. A Textbook of Preventive Dentistry (Second Edition).

DENTIFRICE MANUFACTURER PRINCIPAL ABRASIVE

ABRASIVITY INDEX

Sensodyne Block Drug Co. Silica 157Vote Bristol-Myers Co. Silica 134Plus White Plus Bishop Industries, Inc. Dicalcium Phosphate (anhydrous) 132Plus White Bishop Industries, Inc. Dicalcium Phosphate (anhydrous) 110Gleem II Procter and Gamble Co. Calcium Pyrophosphate 106Macleans (old formulation) Beecham Products, Inc. Calcium Carbonate 93Crest (Mint and Regular) Procter and Gamble Co. Calcium Pyrophosphate 88Close-Up Lever Brothers Co. Silica 87

Pearl Drops Carter-Wallace, Inc.Alumina and Dicalcium Phosphate (dihydrate) 72

Macleans (new formulation) Beecham Products, Inc. Dicalcium Phosphate (dihydrate) 68Ultra Brite Colgate-Palmolive Co. Dicalcium Phosphate (dihydrate) 64Colgate with MFP Colgate-Palmolive Co. Insoluble Sodium Metaphosphate 51Pepsodent Lever Brothers Co. Dicalcium Phosphate (dihydrate) 26

Thermodent Chas. Pfizer and Co.Magnesium Carbonate (basic) and Calcium Carbonate 24

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BINDER

• Function:Used to stabilize toothpaste formulations to prevent separation of the liquid and solid phases

• Characteristics:Can be natural or synthetic

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BINDER

• Types:

– Natural Polymers• Carboxymethyl Cellulose (CMC)• Carrageenans• Xanthan Gum

– Synthetic Polymers– Others

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HUMECTANT

• Function: Used in toothpaste to prevent loss of water and

subsequent hardening of the product upon exposure to air

• Characteristics: Affect taste perception Proper usage level produce a clear translucent toothpaste

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HUMECTANT

• Types:

– Glycerine– Sorbitol– Polyethylene Glycol– Xylitol– Propylene Glycol

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SWEETENER

• Types:

– Sodium Saccharin – Sodium Cyclamate– Acesulfame K

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SWEETENER

• Function: An important part of toothpaste flavoring system

• Characteristics: Government regulations Non-cariogenic

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FLAVOR

• Function: Improve taste of toothpaste

• Characteristics: One of the most important factors for consumer

A mixture of flavoring agents

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FLAVOR

• Types:

– Minty– Fruity– Medicinal– Cinnamon

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Oral products have a unique and specialized flavor requirements. To be successful in oral products, a flavor must:

• Have a pleasant taste while brushing• Leave a pleasant taste in your mouth after

brushing• Be compatible with the base

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All factors being roughly equal – “mouthfeel” appearance, perceived therapeutic attributes, etc. – the consumer will look to flavor as the determinant in selecting a product for use day after day and year after year.

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SURFACTANT

• Function: Produce foam and aid in the removal of debris Emulsifies flavoring agents

• Characteristics: May react with other toothpaste components High level may cause mucosal irritation

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SURFACTANT

• Types:

– Sodium Lauryl Sulfate– Sodium N-Lauroyl Sarcosinate– Sodium Dodecyl Benzene Sulfonate– PEG Oil

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FLUORIDE ACTIVES

• Function: Increase resistance to enamel solubility

• Characteristics: Regulated by Government

Restricted usage level Soluble fluoride ion is essential for activity

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FLUORIDE ACTIVES

• Types:

– Sodium Fluoride NaF

– Sodium Monofluorophosphate MFP

– Stannous Fluoride SnF2

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Anticaries Dentifrices: FDA Tentative Final Monograph

Package size limitation

Identity (labeling)

Indications

WarningsDirections

Aids in the prevention of dental caries or cavities or decay (as deemed appropriate by the manufacturer); misleading statements not permitted

"Adults and children 2 years of age and older; brush teeth thoroughly at least once daily or as directed by a dentist. Children under 6 years of age should be supervised in the use of this product." Also for stannous fluoride dentifrices, "This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist."

None required for dentifrices

Anticaries active agents (category I)

Package shall not contain more than 260 mg total fluorine per package

Contains established name of drug; identifies product as "anticavity", "fluoride", "dentifrice", or "toothpaste", as appropriate

Sodium fluoride, 0.22%Sodium monofluorophosphate, 0.76%Stannous fluoride, 0.4%

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OTHER ACTIVES• Tartar Polyphosphates

Zinc Citrate

• Plaque / Gingivitis TriclosanSnF2Chlorhexidine

Zinc Citrate

• Desensitizer Potassium Nitrate

• Whitening Calcium PeroxideHydrogen Peroxide

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TYPICAL COMPOSITION

Ingredients Weight %Humectants 60 – 20Water 0 – 50Binders 0 – 12Abrasive 18 – 50Flavor 0.5 – 2.0Sweetener 0.2 – 1.0Surfactant 0.5 – 2.0Fluoride 0.2 – 1.2

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U.S. FORMULA COMPARISONIngredients Colgate P&G Unilever SKB

Humectants Glycerin Glycerin Glycerin GlycerinSorbitol Sorbitol Sorbitol SorbitolPEG PEG PEG PEG

Binders CMC Xanthan CMC CMCCarrageenan Carbopol CarrageenanXanthan

Abrasive Silica Silica Silica PCCDical SilicaPCC

Flavor Mint Mint Mint MintSweetener Saccharin Saccharin Saccharin SaccharinSurfactant SLS SLS SLS SLSFluoride NaF NaF NaF MFP

MFP SnF2 MFPSnF2

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TOOTHPASTE CONSIDERATIONS

• Safety• Efficacy• Consumer Friendly

– Pleasing taste– Ease of use– Pleasing appearance

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PRODUCT CRITERIA

• Minimum one year shelf life• Easily dispensable• Compatible with the package• Efficacious• Safe

History of Toothpastes• Dentifrices date back over 2000 years• Colonial America

– mixed own powders and pastes• became popular with re-invention of toothbrush by

William Addis about 1770.

• Dentifrices usually a “family pot”• Invention of the toothpaste tube

– 1892 by Dr. Washington Wentworth Sheffield

History of Toothpastes (cont.)

• Development of fluoride toothpastes– Bibby (1942): first clinical trial of fluoride

toothpaste.– Conventional toothpaste contained dicalcium

phosphate and NaF added.– Fluoride bound to the dicalcium phosphate

causing the NaF to dissociate= inactive fluoride.– No caries preventive effect found.

History of Toothpastes (cont.)

• Development of fluoride toothpastes– Muhler er al (1954)

• used newly developed Ca-pyrophosphate abrasive system

– Caries preventive effect found. (10% caries reduction)

History of Toothpastes (cont.)

• Discovery of Monofluorophosphate– 1940s at Ozark Mahoning Company in Tulsa,

Oklahoma.– By Dr. Harold Hodge, Dr. John Hein, Dr. Wayne

White and Dr. Kanwar Shourie– First described the caries preventive properties of

sodium monofluorophosphate.– Acute toxicity half that of sodium fluoride.

History of Toothpastes (cont.)

• Discovery of Monofluorophosphate– 1940s at Ozark Mahoning Company in Tulsa,

Oklahoma.

– By Dr. Harold Hodge, Dr. John Hein, Dr. Wayne White and Dr. Kanwar Shourie

– First described the caries preventive properties of sodium monofluorophosphate.

History of Toothpastes (cont.)

• Colgate Palmolive Company marketed sodium N lauroyl sarcosinate dentifrice.

• November 1955: Proctor and Gamble marketed Crest, its stannous fluoride dentifrice.

Current Toothpastes• Oriented towards a certain goal: i.e.

– cleaning– anticaries– antimicrobial– tartar inhibition

• Contain many different substances which are necessary to obtain the desired effects i.e. abrasives, active components, motivators.

Fluoride in Toothpastes• The first therapeutic addition to the basic

dentifrice.

• Stannous fluoride (SnF2)

• Sodium monofluorophosphate (Na MFP)• Sodium fluoride (NaF)• Sodium fluoride and Calcium Phosphate

(NaF/CaPO4)

How Much Toothpaste Should I Use ?

• For children: A pea-sized amount of toothpaste to avoid fluorosis.

• For adults: Enough toothpaste to cover the whole length of the toothbrush bristles.

• *Dr. Barry Kaufman for the ADA’s Dental Newsline.

Common Ingredients in Toothpastes

Constituent Concentration (%)

Abrasive 20 - 50

Water 20 - 40

Humectants 20 - 35

Detergent 1 - 3

Thickening agent 1 - 2

Flavoring agent 0 - 2

Sweetening agent 0 - 2

Therapeutic agent 0 - 2

Coloring or preservative 0.05 - 0.5

Common Ingredients in Toothpastes. What Do They Do?

Constituent1. Abrasive2. Water3. Humectants4. Detergent5. Thickening agent6. Flavoring agent7. Sweetening agent8. Therapeutic agent(s)9. Color or preservative10.Binder

Purpose1. Cleaning/stain removal2. Solvent for ingredients3. Provide creamy texture4. Surfactant/foam builder5. Controls viscosity6. Improves taste7. Enhances flavor8. Active ingredient(s)9. Color or preservative10.Holds ingred. together

Common Ingredients in Toothpastes. What Do They Do?

Constituent• Abrasive

Examples• Silica / hydrated silica• Brushite• Gibbsite• Calcite + argonite

Purpose• Cleaning / stain removal• Cleaning effect of one is combined with polishing effect

of another to give the best result.• Cleaning power of abrasive depends on:

– type and amount of abrasive particles– surface it contacts– dilution by saliva– brushing pressure / individual

Common Ingredients in Toothpastes. What Do They Do?

Constituent• Water

Purpose

• Dissolves ingredients allowing them to be mixed.

• Solvent

Common Ingredients in Toothpastes. What Do They Do?

Constituent• Humectant

Examples• Glycerin• Sorbital• Polyethylene Glycol• Paraffin oil

Purpose• Moisturizing agent• Protect toothpaste from drying up during storage• Provides smooth creamy texture• Glycerin and sorbitol are sweet = flavoring agents too.

Common Ingredients in Toothpastes. What Do They Do?

Constituent• Detergent / Surfactant

Examples• Na-laurylsulfate• Sodium laurylsarcoside• Sodium monoglyceride sulfate• ethionates of fatty acid

Purpose• Surface-active substances• Decrease surface tension• Penetrate and loosen debris• Emulsify and remove debris along with the foaming

toothpaste

Common Ingredients in Toothpastes. What Do They Do?

Constituent• Thickening agent /

binding agent

Examples• Xanthum gum• Carboxymethylcellulose• Carrageenan• Carbomer-940 A or

Carbomer-956

Purpose

• Control viscosity

• Hold the toothpaste ingredients together

• Keep the creamy consistency during storage

Common Ingredients in Toothpastes. What Do They Do?

Constituent• Flavoring agent

Examples (Crest)• Regular flavor =

wintergreen• Mint flavor = spearmint

taste• Gel flavor = sweet spice

taste.

Purpose• Provide flavor

Common Ingredients in Toothpastes. What Do They Do?

Constituent• Sweetening agent

Examples (Crest)• Sodium saccharine• Sodium cyclamate

Purpose• Enhances the flavor

Common Ingredients in Toothpastes. What Do They Do?

Constituent• Therapeutic agents

– (Active components)

Examples (Crest)• Fluoride• Triclosan• Metal ions• Sanguinarine• Surface-active subst. • Chlorhexidine

Purpose• In general:

– reduce caries– antimicrobial– inhibit tartar formation– desensitization– anti-inflammatory

Active substances must not be deactivated by the other ingredients.

Common Ingredients in Toothpastes. What Do They Do?

Constituent• Coloring / Preservative

Examples

• Titanium Dioxide

• FD&C Blue No. 1

• FD&C Yellow No. 5

Purpose

• Colorants

• Titanium Dioxide = makes toothpaste opaque. Not in gels.

ADA’s Four Classifications of Toothpastes

1. Anticavity

2. Anticavity / Tartar Control

3. Anticavity / Desensitizing

4. Anticavity / Antiplaque / Antigingivitis / Tartar Control

Anticaries Toothpastes

Tartar Control Toothpastes

Common Tartar Control Ingredients

Examples

• Phosphonates– Tetrasodium pyrophosphate

– Tetrapotassium pyrophosphate

– Disodium pyrophosphate

Tartar Control using Pyrophosphates

• Stabilize the amount of calcium in saliva.• Interferes with calculus’ crystalline structure.

_________________________• Absorbed into the enamel surface as a calcium

complex.• Phosphate is freed from the crystal lattice but

calcium is not.• The calcium rich crystal lattice inhibits the growth

of crystals on the enamel surface and thus the formation of tartar.

Anticavity / Desensitizing

Desensitizing Toothpastes• Basic desensitizing ingredients:

– strontium chloride– potassium nitrate – sodium citrate

Anticavity / Antiplaque / Antigingivitis / Tartar

Control

Baking Soda Toothpastes

Baking Soda• White crystalline powder:

– sodium bicarbonate, bicarbonate of soda, sodium hydrogen carbonate, or sodium acid carbonate.

• Reacts with acids causing effervescence and releasing CO2.

• Neutralizes acid • Cleans with low abrasion• Removes extrinsic stain • Inhibits plaque attachment to tooth

Whitening Toothpastes

Natural Toothpastes

Natural Toothpastes• No dyes or artificial preservatives.• No sweeteners”Tom’s of Main.”• Their nonfluoridated toothpaste has:

– propolis = anitbacterial resin– myrrh = gingival stimulation

• Their fluoridated toothpaste has:– essential oils for flavor– finely ground calcium as abrasive

Xylitol Toothpastes

Calcium Phosphate Toothpastes

Enamelon• Theory is by Dr. Fred Eichmiller at NIST.

• NaF and CaPO4

• Provides fluoride as well as calcium and phosphate which act to strengthen the enamel.

• The soluble calcium and phosphate enhance

remineralization process by converting these

to naturally hydroxyapatite.

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