Smiles Across America webinar 4-21-15

PULPDENT CORPORATION, Bioactivity and Prevention Connie Kugel, RDH, BS Professional Relations & Marketing Manager PULPDENT CORPORATION

Introduction Pulpdent Corporation is a family owned dental manufacturing company founded in 1947.

Administrative offices and shipping department

Warehouse and manufacturing

Manufacturing and R&D

Who is PULPDENT? • PULPDENT CORPORATION is a manufacturer of professional dental materials and operates: • an R&D laboratory . . .

• a chemical production facility • a fully automated machine shop Located in Watertown, MA

Introduction Pulpdent products have a worldwide reputation for excellence and are sold in more than 100 countries.

PULPDENT

Founding Father

Pulpdent’s founder, Dr. Harold Berk, began his career in a public health setting first as an intern and later as the Chief of the Pediatric Clinic at Forsyth from 1940-1946.

Dr. Berk At Forsyth

Founding Father In the early 1950s, together with Dr. Manny Album and other concerned clinicians, Dr. Berk was a founding member of the American Academy of Dentistry for Handicapped Children, now part of the Special Care Dentistry Association and the Academy of Dentistry for Persons with Disabilities.

Founding Father Dr. Berk continued to provide dental care for diverse patient populations in the Pediatric Clinic at Tufts Dental School, where he was a faculty member from 1946-2005.

His Legacy Continues Under the management of Dr. Berk’s sons since 1975, Pulpdent has continued this family legacy and commitment to public health.

PULPDENT

PULPDENT & Public Health Pulpdent supports the public health community in its effort to expand access, increase productivity‚ provide education, champion prevention, and raise the standard of care while reducing costs.

Bioactive Materials Imitate Nature • They are biomimetic, i.e., they mimic nature.

• Bioactive dental materials behave much like teeth and release and uptake significant amounts of calcium, phosphate and fluoride ions.

• They react to changes in the oral environment.

• They play a dynamic role in the mouth.

Bioactive Materials are Dynamic • They have the capacity to interact with living tissue or systems1 • They are “smart” materials that can react to changes in the oral environment to bring about advantageous changes in the properties of the material itself or the material-tooth complex.2 1. Comisi JC. Using bioactive materials to achieve proactive dental care. Oral Health, December 2011:34-46.

2. McCabe JF, et al. Smart materials in dentistry. Aust Dent J 2011;56 Suppl 1:310.

Why is Bioactivity Important?

•

• •

Having an effect on or eliciting a response from living tissue Biologically Active Biomineralization: the exchange of calcium & phosphate ions forming apatite

Prevention Products are Active and Include • • • • • •

Fluoride Calcium Phosphate Xylitol Antimicrobials Other minerals

BIOACTIVITY • Did you know?

1. Resin technology has advanced and can be like tooth structure 2. Minerals are available to promote remineralization 3. Fl2 Varnish products can also contain therapeutic amounts of Xylitol, Calcium and Phosphate

Bioactive Materials for Proactive Dentistry Bioactive materials are considered to have “smart� behavior if: 1. They can react to changes in the environment to bring about advantageous changes in properties, either within the material itself or in the material-tooth complex.** 2. They have the capacity to interact with living tissue or systems.* The development of bioactive materials is inspired by nature.

*Comisi JC. Using bioactive materials to achieve proactive dental care. Oral Health, December 2011:34-46. ** McCabe JF, et al. Smart materials in dentistry. School of Dental Sciences, Newcastle University, UK.

pH Cycles: Demin and Remin • When the pH is low, the demineralization process releases calcium and phosphate ions from the tooth surfaces. As the pH rises, these ions interact with fluoride ions in our saliva and precipitate onto the teeth in the form of acid-resistant fluorapatite.

• Bioactive materials participate in this ionic exchange.

Bioactive Prevention Today we will discuss two preventive dental materials that CAN BE BIOACTIVE: • Pit and Fissure Sealant • Fluoride Varnish

3 Types of Sealant Materials Traditional Resin Sealants Glass Ionomer Sealants Wet-bonding Resin Sealants

Currently Available Moisture-Tolerant Sealants All Glass Ionomer Sealants Embrace WetBond Pit & Fissure Sealant UltraSeal XT hydro Pit & Fissure Sealant

MOISTURE TOLERANT FOR THE MOIST ORAL ENVIRONMENT

PULPDENT CORPORATION

The First Wet-bonding Resin Dental Sealants in 2002

 Bonds to moist teeth  Tooth integrating - Margin-free  Fluoride releasing  Exceptional marginal seal  Eliminates microleakage  Contains no Bisphenol A or BPA derivatives 36.6% filled

A low fill formula is now available to practitioners and public health programs requiring a sealant that is less then 10% filled.

Embrace Low Fill  Self-adjusting  7.9% filled  Off-white shade  Visible on the natural tooth.

The Challenge The challenge for dental researchers has been to develop materials that behave favorably in the moist oral environment.

Traditional Resins are Hydrophobic Traditional dental resins are based on Bis-GMA and urethane di-methacrylate (UDMA) monomers that are hydrophobic, repel water and require a dry environment.

This is not convenient in the mouth.

EMBRACE is Moisture Tolerant EMBRACE™ WetBond™ Pit and Fissure Sealant is hydrophilic, moisture tolerant and forms a positive association with water. It is activated by the moisture that is always present in the mouth.

EMBRACE is Hydrophilic It is water friendly and even mixes with water. In fact, moisture activates Embrace resin chemistry, enabling it to integrate with the tooth and provide a better seal. Apply Embrace WetBond Pit & Fissure Sealant to slightly moist tooth surfaces.

A drop of Embrace Pit & Fissure Sealant is placed on a glass slide.

A drop of water is placed next to Embrace.

Embrace mixes with the water.

EMBRACE: An Acidic Monomer When activated by moisture, Embrace is acidic. In the cured state, the material is no longer affected by water, has a neutral pH and extremely low water solubility of 0.06%.

UNCURED Embrace + WET litmus paper = Reaction indicating pH < 1

CURED Embrace + WET litmus paper = No reaction

Slightly Moist Tooth Surfaces Defined Slightly moist tooth surfaces exhibit neither dryness nor pooling of water. Lightly dry and remove excess water with compressed air or a cotton pellet. Tooth surfaces should be shiny or glossy.

Slightly moist tooth appears shiny and glossy after etching, rinsing and lightly drying.

Dry tooth surface appears chalky white after etching, rinsing and complete drying.

EMBRACE: Tooth Integrating, Margin-free “Embrace showed consistently more intimate marginal adaptation than [the leading competitor] in fissures of the same approximate width and depth.

The superior adaptation and penetration of Embrace may produce longer lasting sealants.”* Embrace exhibits remarkable adaptation to pits and fissures. It integrates with the toothֽ creating a margin-free interface between resin and tooth structure that eliminates microleakage. * Kane B, Karren J, Garcia-Godoy C, Garcia-Godoy F. Sealant adaptation and penetration into occlusal fissures. Am J Dent 2009;22(2):89-91.

EMBRACE: Adaptation Into Pits and Fissures* EMBRACE

CLINPRO

Perfect marginal integrity

Poor marginal integrity

EMBRACE Sealant

Traditional hydrophobic sealant

Perfect adaptation to tooth

Gap Enamel

Enamel

SEM shows EMBRACE Pit & Fissure Sealant without bonding agent. Note intimate adaptation of sealant to the tooth and smooth margin .

SEM shows traditional hydrophobic sealant. Note large gap between sealant and tooth.

* Kane B, Karren J, Garcia-Godoy C, Garcia-Godoy F. Sealant adaptation and penetration into occlusal fissures. Am J Dent 2009;22(2):89-91.

EMBRACE: Antibacterial Properties

Embrace WetBond Pit & Fissure Sealant (white dot in center) Zone of inhibition: 4 mm (dark ring) Strep Mutans

0450 Comparison Of Antibacterial Properties Of Sealants and Amalgam. Sharma S, Kugel G, et al. Tufts University School Of Dental Medicine, Boston, MA,USA

“It’s amazing. I can’t find the margin.”

After curing Embrace, clinicians report they cannot find the margin with an explorer. Embrace is tooth integratingֽ margin-free and perfectly adapted to the anatomy of the tooth, providing an exceptional seal against microleakage.

“Margins are incredibly smooth . . . virtually undetectable.”

Dental Advisor 2004;21(8)

EMBRACE Seals Against Microleakage Microleakage and the inability to create a permanent seal at the margins results in decay and failure of restorations.

Embrace performed exceptionally in marginal leakage testing, without using adhesives or bonding agents.1,2,3 1. Pameijer CH 2. Degrange M; 3. Khanbodaghi A, Kugel G, Sharma S, Ferreira S

BEST SEALANT EVER Here’s what your colleagues have to say about EMBRACE WetBond Pit & Fissure Sealant: “It’s an absolutely sensational product.”

John D. Doykos III, DMD, MSD

“Moist field placement increases success and reduces frustration.”

Peggy Yamagata, RDH, MED

“Margins are incredibly smooth . . . virtually undetectable.”

Dental Advisor 2004;21(8)

“[Sealants] looked the same as they did the day we placed them.”

RDH 2006;26(7):58-60

“Bonds under adverse conditions.”

REALITY 2006

“100% caries free.”

RDH 2006;26(7):58-60

Nothing is Faster or Easier Than EMBRACE

Clean, isolate, etch tooth for 15 seconds.

Rinse well. Remove excess water. LEAVE TOOTH SURFACE SLIGHTLY MOIST.

Apply Embrace sealant on the slightly moist occlusal surface.

Light cure

With EMBRACE Pit & Fissure Sealant, the moisture in the mouth is beneficial, and bonding agents are not required.

Etch, rinse and lightly dry. LEAVE TOOTH SLIGHTLY MOIST. Apply Etch-Rite for 15 seconds.

Apply Embrace WetBond Pit & Fissure Sealant to the slightly moist tooth.

After curing, the margin is undetectable with an explorer.

PULPDENT CORPORATION

CXPâ&#x201E;˘ = Xylitol-coated Calcium and Phosphate for unsurpassed fluoride release

PULPDENT

Embrace Varnish is a permeable resin-based varnish containing 17.6% Xylitol, sodium fluorideой calcium, phosphate, and less than 20% ethanol.

It releases fluoride, calcium and phosphate ions.

4 Years in the Making • A complete Varnish not just Fluoride • Highest Fl2 release in 4 hours (98%) • No separation, predictable dosage and outcome • 18% Xylitol is micro-coating the Calcium and Phosphate. Reactivity takes place in the mouth not in the package!

• Maximum Release, Maximum Benefit

By incorporating xylitol-coated calcium and phosphate in a permeable resin matrix that does not separate, Pulpdent has developed a sustained time-release varnish with uniform dosage that delivers 10 times more fluoride than the leading brand.

CXP Xylitol-coated calcium & phosphate for unmatched fluoride release • Saliva breaks down Xylitol • Xylitol prevents premature binding of phosphate and fluoride • Phosphates enhance the release of Fluoride • Desensitizes

Protective Fluorapatite Saliva exposure dissolves the Xylitol and releases the calcium and phosphate ions. These ions react continuously in saliva with the fluoride ions to form protective fluorapatite on the teeth.

Fluorapatite

Enamel

Better and different than other varnishes:  Permeable, bioactive resin matrix with xylitol-coated calcium and phosphate  Releases 10 times more fluoride than the leading brand  Does not separate – No mixing required  Delivers a predictable, uniform dose  Provides sustained time-release of fluoride

It is best if patients refrain from eating hard foods or drinking hot liquids or alcohol for 3-4 hours after treatment. Eating soft foods for the rest of the day is advantageous. Instruct patients not to brush their teeth for at least 4 hours.

Cumulative Fluoride Release of Leading Fluoride Varnishes (measured in micrograms [mcg] per 50 mg of solid weight)

4-Hour Cumulative Fluoride Release In micrograms relative to 50.0 +/- 1.0 mg solid weight

Fluoride Release (mcg)

1000 900 800 700 600 500 400 300 200 100 0 PULPDENT EMBRACE

Premier Enamel Pro

Preventech Vella

Colgate Prevident

3M Vanish

Yapp R, Powers JM. Fluoride Ion Release from Several Fluoride Varnishes. Dent Advis Res Rpt 45:1, March 2012

Cumulative Fluoride Release of Leading Fluoride Varnishes (measured in micrograms [mcg] per 55 mg of solid weight)

Time in hours

Cumulative fluoride release in mcg

1000

PULPDENT EMBRACE VARNISH

900 800 700

600 500

Competitor varnish

400 300

Competitor varnish

200

#1 Competitor varnish 100

Competitor varnish Competitor varnish

0 1 hr

2 hr

3 hr

4 hr

The Dental Advisor: Report (2-15-12) “Fluoride Ion Release From Several Varnishes” R. Yapp, J.M. Powers

Available in a Tube!

12 mL tube Contains 30-40 applications

Individual Package

Boxes of 50 Boxes of 200

PULPDENT and Oral Health America PULPDENT has had a partnership with Oral Health America since 2007 • PULPDENT provides Oral Health America Kits (OHAK) for qualified programs.

• Retail value of the kit is $335.74 each

Oral Health America Kits These kits include: • 50 Disposable mirrors • 15 x 1.2mL syringes Embrace Pit & Fissure Sealant (off-white shade) • 50 Patient sealant brochures • 1 x 6mL syringes Etch-Rite phosphoric acid etch • 50 x unit dose (.4mL) Embrace Varnish • 1 x 12mL tube Embrace Varnish • Various tips, Instructions • $335.74/retail

â&#x20AC;˘ PULPDENT CORPORATION Contact: Connie Kugel, RDH, BS Professional Relations and Marketing Manager connie@pulpdent.com (617) 926-6666, extension 652