Giomer Technology—Shofu’s Proprietary Bioactive

Technology

Shofu Dental Corporation

• Shofu Inc., headquartered in Kyoto, Japan, is a world-renowned manufacturer of dental materials and equipment, providing high-quality products for a century.

• From its inception, Shofu has been changing modern dentistry by delivering innovative and smart solutions that enhance dental practices around the world.

• Shofu Dental Corporation, headquartered in San Marcos, CA, is a company recognized for award-winning products, all contributing to successful dental treatments.

• Today, Shofu remains one of the top manufacturers of outstanding products used by dentists, dental lab technicians, dental hygienists, and dental assistants in North America.

What is a Giomer• Giomer is a collective term for bioactive materials (nano-hybrid

resin composites—packable, flowable, bulks—cements, bonding agents, sealant, and light-cure varnish) which contain Shofu’s proprietary S-PRG fillers.

– Bioactive/biointeractive: material forms an apatite-like layer on its surface1A; materials interact with or affect the biological tissue1B

– Biocompatible: not harmful to living tissue

• Giomers combine biological effectiveness of glass ionomer (fluoride release/recharge and other beneficial ions) with outstanding physical and mechanical properties, and durable and predictable aesthetics.

1AS.R. Jefferies, MS, DDS, PhD, Bioactive Dental Materials, Inside Dentistry. Feb. 20161BGoldstep F., DDS, Proactive intervention. Taking control with remineralization and bioactive materials, Compendium, June 2012;33;6:3-11

The Giomer concept2

2Shofu, Scientific Evidence, Giomer PRG Technology, 2014:1

The Giomer concept continued

• Giomers are based on S-PRG Technology in which surface pre-reacted glass-ionomer is used as a filler.

• S-PRG fillers are obtained by reacting multifunctional fluoro-boro-alumino-silicate glass filler with polyacrylic acid, in the presence of water.3

• The resultant trilaminar structure forms stable glass-ionomer that allows for release and recharge of beneficial ions while protecting the glass core to improve the material’s long-term durability.

3Shofu, Scientific Evidence, Giomer PRG Technology. 2014:1

Composition of Giomer filler

Functions of Giomer layers

Function of the surface-modified layer

•Protects the filler from water sorption and degradation, giving Giomer materials long-term durability

Functions of the glass-ionomer phase

•Releases and recharges fluoride, F-, and other beneficial ions, Sr2+, AI3+, SiO3

2-, BO33-, Na+

– Acid neutralization– Anti-plaque function– Bactericidal properties

F- : Fluoride ion−Strong inducer of dentin matrix remineralization22 −Improves acid resistance by forming fluoro-apatite−Displays antibacterial effects−Exhibits caries-preventive properties −Converts hydroxyapatite into fluoroapatite to improve acid resistance23,24,25

Sr2+ : Strontium ion−Converts hydroxyapatite into strontium-apatite to improve acid resistance23,26 −Inhibits dentinal hypersensitivity−Promotes bone formation

Biological effects of beneficial ions

22 Saito T, Toyooka H, Ito S, et al. In vitro study of remineralization of dentin: effects of ions on mineral induction by decalcified dentin matrix. Caries Res. 2003;37(6):445-9.23Featherstone JD, Shields CP, Khademazad B, et al. Acid reactivity of carbonated apatites with strontium and fluoride substitutions. J Dent Res. 1983;62(10):1049-53 24Iijima Y, Koulourides T. Fluoride incorporation into and retention in remineralized enamel. J Dent Res.1989;68(8):1289-92 25Zero DT, Fu J, Espeland MA, et al. Comparison of fluoride concentrations in unstimulated whole saliva following the use of a fluoride dentifrice and a fluoride rinse. J Dent Res. 1988;67(10):1257-62 26Dedhiya MG, Young F, Higuchi WI. Mechanism for the retardation of the acid dissolution rate of hydroxapatite by strontium. J Dent Res. 1973;52(5):1097-109

AI3+ : Aluminium ion−Improves radiopacity−Inhibits dentinal hypersensitivity

SiO32- : Silicate ion

−Strong inducer of dentin matrix remineralization22 −Promotes bone formation

BO33- : Boron ion

−Exhibits bactericidal properties

Na+ : Natrium (Sodium) ion −Improves radiopacity

Biological effects of beneficial ions continued

22 Saito T, Toyooka H, Ito S, et al. In vitro study of remineralization of dentin: effects of ions on mineral induction by decalcified dentin matrix. Caries Res. 2003;37(6):445-9.

Giomer vs. glass-ionomer & compomer

Glass-ionomer and compomer absorb water into the filling after placement

– Moisture activates fluoride• Causes glass to expand

material degradation

Giomer has surface-modified layer• Which protects the glass core from

– Moisture– Material degradation

Advantages of glass-ionomer•Adhesion to moist tooth structure •Biological compatibility •Anticariogenic properties due to fluoride release

Deficiencies of glass-ionomer•Lack of toughness•Early water sensitivity•Low abrasion resistance and porosity which lead to poor surface polish

Category Fluoride Release Recharge Water Sorption Aesthetic Bioactive or Biointeractive

Giomer Yes Yes No Yes Yes

Glass-ionomer Yes Yes Yes No Yes

Compomer Yes No Yes Yes No

Clinical benefits of Giomer materials

• Release and recharge fluoride4,6,7 and other beneficial ions11,15

• Form acid-resistant layer4 which can transpose to adjacent teeth13,16,27

• Neutralize acids to establish stable pH in the oral environment14

• Inhibit biofilm formation and disrupt mature biofilm4,5

• Exhibit anti-plaque properties by reducing plaque formation & bacterial adherence8,9,10,14

• Possess antibacterial functions10,11 • Exhibit caries-preventive

properties12

• Have the potential for secondary caries prevention7,9,10,14,17

4Shofu, Scientific Evidence, Effects of surface pre-reacted glass ionomer fillers on mineral induction by phosphoroprotein. 2011:45ibid, Effects of S-PRG eluate on oral biofilm and oral malodor. 2014:5 6ibid, Fluoride release and recharge capabilities of orthodontic resin containing S-PRG filler. 2013:67Han L, Cv E, Li M., et al. Effect of fluoride mouth rinse on fluoride releasing and recharging from aesthetic dental materials, 2002. 21: 285-295 8Shofu, Study on the file layer produced from S-PRG filler. 2004:89 ibid, The anti-plaque effect of fluoride releasing light-cured composite resin restorative material. 2002:9 10ibid, Antibacterial activity of composite resin with glass-ionomer filler particles. 2010:10 11ibid, Antibacterial activity of S-PRG filler. 2003:18 12ibid, Caries-preventive effect of fissure sealant containing surface reaction-type pre-reacted glass ionomer filler and bonded by self-etching primer. 2012:20 13ibid, Acid resistance induced by a new orthodontic bonding system in vitro. 2008:21 14Gordan V.V., et al. A clinical evaluation of a self-etching primer and a Giomer restorative material: results at 8 years. JAM Dent. Assoc. 2007;138:621-627 15Kamijo K., Mukai Y., et al. Fluoride release and recharge characteristics of denture-base resins containing surface pre-reacted glass-ionomer filler. Dent. Material J. 2009;28:227-23316Han L., Okamoto A., et al. Evaluation of a new fluoride-releasing one-step adhesive. Dent. Material J. 2006;25:509-515 27Forsten L. Resin-modified glass ionomer cements: fluoride release and uptake. ActaOdontol Scand. 1995;53(4):222-5

Release/recharge of fluoride

and other beneficial ions

Acid neutralization to establish stable pH in the oral environment

• pH: power of hydrogen

• The numbers on pH scale change by the factor of 10

– pH of 3 is 10x less acidic than pH of 2

– pH of 1 is 100x more acidic than pH of 3

Less plaque Full grown plaque

Competitive material(without S-PRG fillers)

Beautifil II (with S-PRG fillers)

SEM images of plaque on restorative surface after 24 hours without brushing

Anti-plaque properties by reducing plaque formation & bacterial adherence

Clinical benefits of Giomer materials continued

• Demonstrate excellent physical and mechanical properties for durable and predictable aesthetics14,18,19,21

– Excellent optical properties: radiopacity greater than enamel20

– Superb polishability and luster20

• Exhibit optimal handling which helps improve marginal adaptation and contouring of restorations, without slumping or sticking17

• Available in variety of shades to provide life-like aesthetics

17Milnar F., Direct composite and finishing/polishing systems for esthetic anterior restorations. Inside Dentistry, Oct. 2014:58-6218Milnar F., Conservatively recreating a smile. Dentistry Today, Feb. 2016 19Gordan V.V., et al. A clinical evaluation a Giomer restorative system: 13-year recall. JAM Dent. Assoc. 2014;145;10:1036-104320Yapp R.A, MS, Cowen M, BS, Powers J.M., PhD, The Dental Advisor, Apr. 2015;32;3: 721Abdel-karim U.M., El-Eraky M., Etman W.M., 3-year clinical evaluation of two nano-hybrid giomer restorative composites. 2014:214-222

Excellent physical & mechanical properties for durable & predictable aesthetics

• 8-year study published in JADA, 200714

• 16 of 26 Class I, and 25 of 35 Class II restorations were observed

• No failures• No secondary caries• Maintained aesthetics• No post-op sensitivity

• 13-year study presented at IADR, 2013 poster session19

• 19 of 26 Class I, and 22 of 35 restorations were observed

• 66% retention rate (27 of 41)• 3.27% secondary caries rate

(2 of 61) restorations

13-year StudyPhotos

Overall positive results and low secondary caries attributed to Giomer technology.

Environmental condition (Temp ： 37 /98.6 F, Humidity℃ ： 70 ％）

Beautifil II BEAUTIFIL ClearfilAP-X

ClearfilMajesty

Solare

FiltekZ250

FiltekSupreme

PALFIQUEEstelite

PALFIQUEEstelite

Poor handling in simulated oral environmentGood handling in simulated oral environment.

Optimal handling

Optimal marginal adaptationSureFil SDR Beautifil Flow

Plus

Excellent physical & mechanical properties for durable & predictable

aesthetics20

Excellent optical properties: radiopacity greater than enamel20

F03F00

Enamel = 2.0 Al:mmDentin = 1.0 Al:mm

Giomer Clinical Case F. Milnar, DDS, AAACD17

(1.) Close-up preoperative retracted view of the patient’s central incisors demonstrating the extent of damage from sugar and oral disease. (2.) The conservative preparation

design included a starburst bevel. (3.) A total-etch technique was performed on the dentin and enamel. (4.) After rinsing and drying, an adhesive bonding agent was

applied and light cured. (5.) Using shade A3 first, Beautifil II composite was applied using a freehand technique.

(6.) Shade A2 of the Beautifil II composite was blended over the A3 layer to create abstract undulations and produce light diffusing areas. (7.) A final enamel layer in shade A1 of the Beautifil II composite was placed on top of the A3 and A2 buildup. (8.) An artisan’s approach to finishing was taken to prepare the restoration surfaces. (9.) The primary anatomy was redefined by marking the transitional line angles. (10.) Higher luster for light reflecting zones was imparted in appropriate areas of the restoration morphology. (11.) Transitional line angles, certain aspects of micromorphology, and the center third of tooth No. 9 were properly managed and optimized. (12.) Using water spray and very low torque, larger volumes of composite material were carefully and lightly buffed.(13.) The proper value of the adjacent teeth was achieved in the restorations. (14.) The 1:1 postoperative view demonstrates the desired value, outline form, and natural esthetics.

Award-winning Giomer products

22

• Beautifil Flow – injectable flowable • Beautifil Flow Plus – injectable nano-hybrid composite • Beautifil II – packable nano-hybrid composite• Beautifil-Bulk Flowable – flowable bulk-fill composite • Beautifil-Bulk Restorative – bulk-fill composite • BeautiSealant—pit-and-fissure sealant without etching• PRG Barrier Coat—light-cured varnish for prolonged relief

from hypersensitivity

… and many other…