Dentrifices, Mouthrinses, Chewing Gum and Product Safety Regulation

Dentifrices Definition

Substances used to clean the teeth, commonly referred to as toothpastes

Mouthrinse definition

Used to flush food debris from the oral cavity, freshen breath, or if fluoridated, to deposit fluoride on the teeth

Chewing gum definition

A newer category of products with cosmetic claims and the ability to deliver therapeutic compounds

Mouth rinses

Available in liquid form, the traditional method for stabilizing and delivering many pharmaceutically active agents

•“fresh breath” or “clean feeling”

Mouthrinses are considered by consumers to have primarily cosmetic benefits

But it has therapeutic benefits as well

Mouthrinse components basics

Active ingredients

Astringents

Solvent

Mouthrinse active ingredients

• Quaternary ammonium compounds

• Phenolic compounds

• Sanguinarine

• Chlorhexidine

• Essential oils

• Fluoride

• Triclosan

Mouthrinse astringent ingredients

• Alum, zinc, stearate, zinc citrate, and acetic and citric acids

Mouthrinse solvent ingredients

alcohol

Pleasant sensation in mouthrinses are enhanced by which components of mouthrinse (active ingredient/astringents/solvent)

astringents

A solvent is a taste enhancer (true/false)

true

Alcohol mouthrinses that have the ADA seal of acceptance must have a child resistant cap and other safety measures (true/false)

true

Functions of mouthrinses basic

preventive-prevent caries, reduction of biofilm and gingivitis, desensitizing; Zinc sulfate reduces biofilm

cosmetic-remove extrinsic stain and halitosis; Zinc chloride reduces halitosis

therapeutic-remineralization, antimicrobial/antibacterial, reduces xerostomia; Oasis by Sensodyne, Biotene, Peridex

We get the most benefits of mouthrinses when we use it with

brushing and flossing

More successful in reducing plaque, gingivitis, and preventing caries

Cosmetic Mouthrinses

Halitosis:

• Caused by bacteria and plaque accumulation in oral cavity

• Tongue

• 10% from nonoral/systemic causes

Mask odors (no effect after 2-5 hours)

Zinc chloride:

• Neutralizing volatile sulfur compounds

• Kills gram – bacteria

Therapeutic mouthrinses

• Chlorohexidine Gluconate

• Essential Oils

• Quaternary Ammonium Compounds (cetylpyridinium chloride)

• Fluoride

• Triclosan

• Xerostomia

Chlorhexidine gluconate

Brand: Peridex (must be prescribed by dentist)

0.12% solution used in United States

Must be prescribed by dentist

Directions call for a twice-daily, 60-second rinse with one-half ounce.

Used for: inhibit bacterial colonization

• Pre-procedural rinse before aerosol procedures and etc

• Before, during, and after NSPT (non-surgical periodontal therapy)

• Disadvantage: causes some staining and altered taste

*Chlorhexidine has proven to be one of the most effective anti-plaque agents to date* due to substantivity (8-12 hours)

Substantivity

able to linger in the mouth for a longer period of time

Essential Oils

• Controlling plaque & gingivitis

• Disrupts cell wall of bacteria

• Due to alcohol content, may cause burning or irritation to tissue

• Listerine-Contraindications? Peeps with xerostomia, or alcohol abuse

Bacteria not resistant

Just rinsing won’t be effective in treating periodontal pockets since rinsing doesn’t reach depts of periodontal pockets

Quaternary Ammonium Compounds (CPC)

• Disrupts bacterial cell membrane

• Reduce plaque and gingivitis up to 12 hours

Examples:

• Crest Pro-Health

• Scope

• Rembrandt

No alcohol, claims no burning sensation and helps with halitosis

Fluoride

• Anticaries

• Sodium fluoride, Stannous fluoride, acidulated phosphofluorides

• Stannous and APF are NOT for weekly use!!!!!!! Only sodium fluoride

Recommended for:

• Moderate-High risk caries patients

• Ortho patients

• Patients with fixed appliances

• Patient receiving radiation therapy (decrease salivary flow=caries)

• NOT recommended for children under the age of 6 (upset stomach if they swallow it)

Ex) Act mouth rinses and pro health maybe

Triclosan

• Reduces biofilm and gingivitis

• Not marketed in the US

• Colgate total like colgate toothpaste

Xerostomia Mouthrinses

• Artificial saliva substitutes

• Moistens & lubricates mucous membrane

• Usually contains fluoride, calcium, and phosphate

Examples:

• Sensodyne: Oasis Mouthwash

• Biotene

• Orazyme Dry mouth mouthwash

Chewing gum

Have the potential to be used by the consumer for periods of 5-20 minutes several times a day

Enable delivery of a cosmetic or therapeutic agent for a longer time than with dentifrices or mouthrinses

Stimulate salivary flow

Mechanical removal of dental plaque and debris

Sugar free gum

Contain polyol sweeteners such as sorbitol or xylitol; these sweeteners are not broken down by plaque or oral microbes to produce acid

Xylitol is considered non-acidogenic and not fermentable by bacteria responsible for caries production

Xylitol (maintain neutral pH during and after chewing) is most effective, followed by sorbitol

Reducing plaque accumulation; reaching tooth surfaces commonly missed

Agents added to chewing gum

Chewing gum facts

FDA regularly tests the safety and efficacy of all chewing gums on a regular basis, holding to all rigid guidelines during testing

Chewing gums have not been approved by the FDA as having any therapeutic properties

Orbit and Extra the 1st sugar free gums to be awarded the ADA Seal of Acceptance

Product Regulation

FDA-safety, efficacy, and security of OTC and prescription drugs

Federal Trade Commission (FTC)-advertising of OTC and prescription drugs to protect consumers against false claims

Safety-potential to create no harm of discomfort to patients

Efficacy-ability to create a positive outcome

Stages of FDA Approval basic

1. Preclinical research and development by the manufacturer: Animal testing, lab testing, toxicity evaluation

2. FDA review of manufacturing information on the drug product: Submitted as part of an IND application (investigational new drug)

3. Clinical research conducted by the manufacturer after approval of the IND application

Investigate Process Phases

Phase 1:

• Study is limited in scope and uses 30-80 healthy volunteers to determine safe dose to humans

• Ingestion of dental products (injection or topical)

• Excessive topical applications to oral mucosa or teeth (2-4x daily to determine safe dose)

Phase 2:

• Several hundred subjects with the disease or condition

• Demonstrate the initial clinical efficacy of the drug (is it going to treat what is said to treat?)

• Define a dose range that is safe and efficacious

Phase 3:

• Several hundred to several thousands of people

• Expanded controlled and uncontrolled trials with “final” formulas

• Demonstrate long-term safety and efficacy

Duration of Investigate Process

Plaque and gingivitis-3-6 months

Caries-2-3 years

After investigate process

New drug application (NDA)-contains data from trials

FDA reviews and approves the NDA

Marketing begins-post-marketing surveillance of the product is mandatory

FDA requirements of products

Manufacturer must provide:

• Active ingredients and purpose

• Inactive ingredients

• Listed alphabetically

• Indicated objective of active ingredient must be on the label

• Proof must exist to make claim

Packaging and labeling guidelines

• Indication of the product (what it’s used for)

• The product’s use

• A warning

• Directions for use

ADA’s role

CSA: Council on Scientific Affairs

• Reviews dental products on a voluntary basis

• Study, evaluate, and disseminate information

• Consults with dental professional (not member of ADA)

ADA Seal of Acceptance: helps advertise products to the public

• Marketing tool

The ADA acceptance label is provided by the CSA or FDA

CSA