Dear Dr. Gheewalla : May 14,2014

"In short, it can be seen that L.E.n. ProSeal® lasted for 3 years of extensive tooth brushing with avery abrasive paste, whereas most enamel surfaces covered by Opal Seal" would have lostprotection after only 9 months of brushing."

" .... the rate of sealant loss of L.E.D. ProSeal® was remarkably lower than that of Opal Seal®"

Independent Study by Georgia Regents University - (SeeAttached)

There is nothing more frustrating than to properly diagnose and treat a case only to find demineralizedenamel at the de-bond appointment. There are several options to help fight decalcification. The first isa constant fluoride presence - impossible to accomplish intra-orally for long term protection. Fluoride-releasing composites, fluoride varnishes, and fluoride treatments have all failed due to either lack ofpatient cooperation or dissipation of fluoride release (even with recharging capability). The second is toapply a highly filled sealant that lasts a short period of time and has to be reapplied - not a viableoption for the length of an orthodontic case.

The only method not requiring patient cooperation that has proven successful is to place a clear,protective layer on the enamel surface that will not break down in the presence of oral fluids, acid,sugar, abrasive brushing or mastication. ProSeal® is the only sealant on the market that will last 2 - 3Years. ProSeal® is a highly filled, high fluoride releasing light cure sealant, but where PrcSeal'" picks uplong-term durability is through a patented catalyst system that cures with no porosity. When ProSeal®is light cured, a complete cure of the resin is achieved - resisting penetration from acid bacteria,carbonated beverages, etc.

ProSeal is not only an enamel protective sealant, but serves as a primer too. Simply etch, rinse and dry.Apply 1 coat of ProSeal®, light cure and place bracket. Whether your office utilizes a chemical cure, dualcure, or light cure adhesive system -Proseal" is compatible. Self-etching or traditional phosphoric acidcan be used in the etching process before the ProSeal® is applied. ProSeal® contains a fluorescing agent

___ "__ .that makes application and removal a breeze.

Call our office for this special offer pricing: 1 - 6ml bottle - enough material for at least 1500 teeth -$60.00 - limit one - when you reference this mailing. As always, your satisfaction is guaranteed - offerexpires June 30th

, 2014.

Thank you for your consideration.

Paul Gange Jr

P.O. Box 678, Itasca, IL 60143 • www.RelianceOrthodontics.com

Toll Free 1-800-323-4348 (USA) • Phone - 630-773-4009. Fax - 630-250-7704

INTRODUCTIONEnamel surface sealants have been developed to providea physical barrier between underlying enamel and theaccumulation of acid-producing plaque surroundingorthodontic brackets and wires. Because of accessdifficu ltv, patients have difficulty in adequately removingaccumulated debris and plaque round these intricateplaces, leading to the possibility of enameldecalcification, evidenced as either white spot lesions orovert cavitation 0 r decay.

Cavitation, Decay

Gingivitis http:}/Iondonormo.ca/page-/b10£?id-266

With a polymerized layer of resin covering exposedenamel surfaces placed prior to bracket delivery, thedestructive processes of acid demineralization of toothstructure is inhibited. However, with the averageduration of orthodontic cases running at least 24 months,the ability of these polymer-based products to resisttoothbrush abrasion is important, in providing long-termenamel protection.

PURPOSETo measure and compare long-term toothbrushing wearrate between two manufacturers of a light-cured enamelsurface sealants.

HYPOTHESISBecause compositional differences between these

products are not known, there is no reason to assumethat their long-term toothbrushing wear rate would besign ifi cantJy cliffe rent.

METHODSENAMEL SURFACESEALANTSTESTED

opal=sealopal"'ORTHODONTICS,UItradent Produ cts, USA

38% filled with GI and nano-fillers

UV-fluorescent10-s exposure if> 600

mW/cm2

l.E.D. PRO SEALReliance OrthodonticsItasca,ILSet without O2 inhibition

layerContains GI particles for F

releaseUV-fluorescent10-s exposure with blue LED

EXPERIMENTALFLOW CHART

r-/':'::':::~'- .....'..••=:r;1.!~

• Flattened, polished (600 grit SC)bovine enamel squares• Lateral 300 urn-deep dimples placed (for height references)• Specimens fixed in custom 3-D pr-inced hQld~T~

• Surface scan enamel surface (Form TalySurf, Taylor Hobson, UK)• Enamel surface acid etched, dried, sealant placed, light-cured 20·5 (Elipar

S10, 3M/ESPE -1,067 mW/cm2) (4 specimens per product)• Re-scan specimen to record as-placed sealant height profile above enamel• Place in toothbrushing machine (VB-Sabri Enterprises)

• Random machine station assignment between products• Toothbrush: flat, Regular Straight 47 Medium, Ranir Corp, MI, 200 gforce

• Toothpaste slurry (SOw/SOv)Crest Pro-Health, (166/200 RDA- > highlyabrasive) ...';=~

• lS;O()(}strokes =J: year of Simulated brushing = tssza&• Specimen removed at 3-month intervals (4,7S0 cycles), surface rescanned,new slurry, continued brushing

• Measured area (square microns) under plane from dimple bottom-to-dimple bottom every 3 months

• Regression analysis: rate of area loss with duration of brushing

RESULTSWEAR RATEEXAMPLES

/"''''-~ "'~ "g 50r--'~----------~-----

"~-sc

_ •• ~o ••••

"..,,,,,.,

·,50\ I X.,odlC \\1 II-aco l

\N()TH(rncrons)

l.E.O. PROSEAl

.•••1+--1-----1

OPAleSEAl

COMPARATIVE MONTHLY WEAR RATES

9JOO 1 y = S6x+ 5004 R2= OB07I~.~~.~.,".~'.~mJoJ1

1

- j_.~~ ~ l---r----I~ • OPM.'!"SEAl.[w~3000

en

9

• L.E.D. PROSEAL

2000s= 1.6x+770 R'=O.294

p-value slope: 02084. 95% CI: ·1.310 4.4

1000

! + ", , , , ,

00 10 15 20 25 30 35 40

SIMULATED DURATION OF TOOTHBRUSHNG (MONTHS)

CONCLUSIONS1. Wear rate significantly different between products:

OPAL"'SEALwears at 35X greater rate than L.E.D.PROSEAl

2. Wear rate of l.E.D. PROSEAL,after 3 months in servicedoes not significantly differ from zero: p = 0.2084

eoco