C l i n i c i a n s G u i d e t o D e n t a l P r o d u c t s & Te c h n i q u e s

Volume 27, Issue 3 March 2003

CRA
FIRST LOOK NEW GENERATION IN-OFFICE VITAL TOOTH BLEACHING, PART 2
This is the 2nd report (See CRA Newsletter Nov. 02 for Part 1) in an on-going evaluation of in-office vital
tooth bleaching products addressing what lights add to in-office bleaching. Report below addresses:
(1) Frequently asked questions; (2) Characteristics of 8 in-office bleach systems; (3) Clinical test
methods & results; & (4) CRA conclusions.
IN
THIS 1. FREQUENTLY ASKED QUESTIONS (SEE CRA WEBSITE FOR TEST METHODS & SUPPORTING DATA)

ISSUE: A. Can teeth be lightened in 1 visit? YES

However, CRA data show amount of lightening varies by person, & by chemistry & contact time of the bleach system used. In
NEW controlled clinical studies where manufacturers instructions were followed exactly, the amount of lightening
GENERATION experienced by patients varied within each specific bleach system by 0.3 to 1.0 shades on the Vitapan 3D- Master Shade Guide.
IN-OFFICE
VITAL TOOTH B. Will teeth lighten 8 -12 shades? DEPENDS ON MANY FACTORS
BLEACHING,
PART 2 Some important variables include type & intensity of tooth discoloration, patients individual characteristics, shade guide used,
grader, & when after-bleach grading takes place. Many product promotions use the Vita Lumin Shade Guide arranged by
Pages 1 - 3 value (grayness) where only one person serves as the grader. In addition, it is important to note that no shade guide available
currently is designed to assess color changes in teeth undergoing bleaching. CRA used 3 graders, trained in the use of the
Vitapan 3D- Master Shade Guide to grade color independently. This shade guide was used because: 1) It is based on
EDGE EASE natural color of human teeth & not restorative materials; 2) It provides separate readings of the 3 variables of tooth color (value,
X-ray film cushion chroma, & hue) to allow improved repeatability & agreement of color assessment; 3) The representations of value & chroma
are evenly spaced; & 4) Color samples on the guide cover the color space for teeth.
Page 4
C. Does light use enhance results? NO LIGHT YET EVALUATED BY CRA HAS ENHANCED RESULTS
ISNT IT Systems tested by CRA using a split arch design where contralateral teeth received the same bleach gel for the same contact
WONDERFUL time, with or without light use, showed comparable lightening results. Many think heat from lights is a catalyst in the
WHEN PATIENTS decomposition of the bleach gel. However, CRA tests of current systems show in vivo temperatures at the tooth surface under
SAY YES gels illuminated according to manufacturers directions ranged from about 32C which is below body temperature (37C), to
Case acceptance about 45C which is slightly above body temperature. Laboratory tests could not show significant affects of the light on bleach
gel decomposition. However, CRA continues to test light / bleach systems carefully. Theoretically, a gel could contain a
Page 4 chemical that reacts with a specific light, but none has yet been found.

D. Do bleaching lights differ from each other? YES

ORIGINATE
Impression trays Lights recommended currently by manufacturers for bleaching include halogen, plasma arc, LED, & diode laser. Designs
include conventional halogen resin curing lights with 8mm to 11mm diameter light guides, larger table top diode laser with
Page 4 a unique handpiece to illuminate several teeth at a time, & floor units with articulating arms that deliver light to the
12 anterior teeth simultaneously.

ONETOUCH Most light is emitted mainly in the visible spectrum. Biolase diode laser emits non- visible light in the near infrared, & Zoom
Topical anesthetic has a small portion of its emission in the ultraviolet.
Some lights are designed only for bleaching (Zoom, LumaArch, BriteSmile) while others serve multiple functions
Page 4
(LaserSmile - soft tissue surgery; Rembrandt - resin polymerization).

E. Can I interchange brands of bleach & lights? YES

CRA data show no light tested to date improved tooth lightening over use of the bleach gels alone (see CRA Newsletters: Nov 02,
Apr 00, Apr 97). Since none of the lights contribute to tooth lightening, it makes no difference if system components are mixed.

F. What are CRAs comments on the BriteSmile system & the JADA Feb. 03 report?
CRA has the following concerns: 1) Only one person performed all tooth color grading; 2) There was no indication that the
grader was trained or validation of the graders ability to judge colors consistently over time; 3) No prophy was performed
TM
prior to bleaching to remove extrinsic stains so accurate tooth color readings could be made initially; 4) The study was
funded by BriteSmile & the Director of the Forsyth Institute where the study was performed was on the BriteSmile Strategic
Since 1976 Advisory Committee of Industry Experts; & 5) BriteSmile requires all dental clinicians who wish to have a BriteSmile light in
3707 N. Canyon Road #6 their clinical facility to sign an extensive contract that includes a paragraph stating that the Client shall not, and shall not
Provo, Utah 84604 permit any person, to analyze or attempt to quote reverses engineer the BriteSmile System(s), Authorization Code, or the
801-226-2121 BriteSmile Materials while in their possession. A contract & stipulations of this type are infrequent in dentistry & beg the
question: Why?
www.cranews.com
CLINICAL SUCCESS IS THE FINAL TEST.
CRA Newsletter Page 2 March 2003

2. CHARACTERISTICS OF 8 IN-OFFICE BLEACH SYSTEMS

Bleach systems tested are listed alphabetically left to right by system name.
Rembrandt
Opalescence 1 Hour Smile
Bleach System BriteSmile LaserSmile LumaArch Niveous PolaOffice Whitening Zoom
Xtra Boost
Program
BriteSmile Biolase Lumalite Shofu Dental Ultradent SDI Den-Mat Discus Dental
925-941-6260 949-361-1200 619-660-5410 760-736-3277 801-572-4200 630-238-8300 805-922-8491 310-845-8200
Company 800-274-8376 888-424-6527 800-400-2262 800-827-4638 800-552-5512 800-228-5166 800-433-6628 800-422-9448
Fax: 925-941-6270 Fax: 949-361-0204 Fax: 619-660-5459 Fax: 760-736-3276 Fax: 801-572-0600 Fax: 630-238-9200 Fax: 805-922-6933 Fax: 310-845-1537
www.britesmile.com www.biolase.com www.luma-light.com www.shofu.com www.ultradent.com www.sdi.com.au www.denmat.com www.discusdental.com
PRODUCT INFORMATION
BriteSmile LaserSmile LumaWhite Niveous Opalescence PolaOffice Rembrandt Zoom Whitening
Gel Name Procedure Gel Xtra Boost Lightning Plus Gel
A (Ready to use (Liquid powder mix) (Liquid ampule with (Liquid powder mix)
(components) (Ready to use syringe) booster brush mix) (Connect two (Dual syringe (Dual syringe
syringe) syringes & mix) w/ automix tip) w/ automix tip)

Cost of
$250 $49.95 $79 $169.95 $95.95 $110 $120 $85
B Whitening Kit
(1 patient) (1 patient) (4 patients) (5 patients) (2 patients) (3 patients) (2 patients) (1 patient)
(patients treated)

Storage Room
C Refrigerate Refrigerate Refrigerate Refrigerate Refrigerate Refrigerate Refrigerate
Conditions Temperature
Chemical
D Yes No Yes Yes Yes Yes Yes Yes
Catalyst

Yes Yes Yes Light Optional Light Optional Light Optional Yes Yes
Light Use
BriteSmile LaserSmile diode LumaArch If used, a standard If used, a standard If used, a standard Rembrandt Zoom
E Recommended Sapphire
by Company (Mercury Vapor laser with whitening (Halogen) resin curing light resin curing light resin curing light (plasma arc with (Metal-Halide)
Plasma Arc or LED) handpiece is suggested is suggested is suggested Whitening Crystal)
Light owned by $22,900
Cost of Light BriteSmile. Use $1,500
F included in patient (Soft tissue & $4,995 N/A N/A N/A $4,650
system bleaching laser)
UV meter $150
kit cost.
PRODUCT LABEL CLAIMS & CRA ASSAY RESULTS
% H202

Per Mfr. 15% 35% 35% 27% 38% 35% 35% 25%
(wt%)

Assayed conc. 17.8% 36.7% 41% 27.2% 41.5% 41% 35.7% 28%
Per Mfr. not available not available 5.5 5.5 7.0 5.0 8-9 7-8
Mixed

H
pH

6.1
CRA assay 4.0 5.6 4.0 7.5 3.0 5.9 7.9
MANUFACTURERS DIRECTED USE
Contact Time
I per Gel 20 minutes 8 minutes 8 minutes 15 minutes 15 minutes 4 minutes 60 minutes 20 minutes
Application
Gel
J Applications 3 3 3 3 4 4 1 3
per Visit
Total Gel
K 60 minutes 24 minutes 24 minutes 45 minutes 60 minutes 16 minutes 60 minutes 60 minutes
Contact Time

Total Time Light 6 minutes 2 minutes 2 minutes

L 60 minutes 3 minutes 24 minutes (light use is optional (light use is optional (light use is optional 60 minutes 60 minutes
on Each Tooth per manufacturer) per manufacturer) per manufacturer)

Estimated Total
M 90 minutes 51 minutes 54 minutes 73 minutes 90 minutes 45 minutes 90 minutes 100 minutes
Chair Time*

Method followed was: Hydrogen peroxide concentrate. United States Pharmacopeia XXII NFXUII 1990, pp 663.

* Includes standardized times for: Pre-procedure prophy (5 min.), pre-procedure

material (4 min.), post-procedure photos (2 min.).
photos (2 min.), soft tissue isolation (10 min.), gel removal & reapplication (2 min.), removal of isolation

Includes 7 minute topical Fluoride application after bleach procedure.

SUMMARY OF CHART: (Letters below correspond to letters at left of chart above.)

A. Bleach gels have 4 types of dispensing: (1) Ready to use syringes (single barrel
or dual barrel with automix tips); (2) Separate liquid & powder requiring chairside
mixing; (3) Separate syringe requiring joining & mixing; & (4) Liquid requiring
mixing by provided microbrush.
B. Kit costs range from $49.95 to $250. Cost per patient use range from $19.75
(LumaArch) to $250 (BriteSmile).
C. 7 of 8 systems require bleach kits to be refrigerated. Zoom indicated room
temperature storage was acceptable.
D. 7 of 8 systems include a chemical catalyst or activator that is added to the H202
gel just before use. LaserSmile does not include this step.
E. 5 systems mandate use of a light, & 3 indicate light use is optional.
F. Cost of lights sold only for bleaching range from $1,500 (Zoom) to $4,995
(LumaArch). Biolase (LaserSmile) is a soft tissue laser ($22,900) with a unique
handpiece to illuminate several teeth at a time when used for bleaching.
BriteSmile loans their light, & it is not owned or leased by dentist.
G. Manufacturers state H202 concentrations of 15% to 38%. CRA assays show
concentrations at or higher than manufacturers claims (28% to 41.5%).
H. Six manufacturers state pHs of mixed gel at 5.0 to 9.0. CRA assays show pHs
range from 3.0 to 7.9. (As pH is raised, H202 decomposes more readily.)
I. Gel contact times per application ranged from 4 minutes (PolaOffice) to 60 minutes
(Rembrandt).
J. Manufacturers recommended number of gel applications ranged from 1 (Rembrandt)
to 4 (Opalescence, PolaOffice).
K. Total gel contact time following manufacturers directions ranged from
16 minutes (PolaOffice) to 60 minutes (BriteSmile, Opalescence, Rembrandt, Zoom).
L. Total time light illuminated each tooth following manufacturers directions ranged from
2 minutes (Opalescence, PolaOffice) to 60 minutes (Brite Smile, Rembrandt, Zoom).
M. Estimated total chair times range from 45 minutes (PolaOffice ) to 100 minutes
(Zoom).
CRA Newsletter Page 3 March 2003

3. CLINICAL TEST METHODS & RESULTS

A. METHODS
Potential participants were screened for yellow/orange tooth color. Teeth received flour of pumice prophy from same clinician & shades were taken
before treatment, & immediately after treatment, & 1 week after treatment independently by 3 trained graders in a standardized location with color
corrected lighting, using the same Vitapan 3D-Master Shade Guide. (At least 2 of the shade graders were within a half shade 97% of the time.)
Qualifying participants were stratified into 3 degrees of darkness by average shade across 12 anterior teeth, & 1 patient from each group was assigned
randomly to each of the 7 bleach systems.
Teeth were treated following each bleach manufacturers directions strictly, using a split arch design where centrals, laterals, & canines on 1 side
received bleach plus light, & contralateral teeth received same bleach for same contact time, but no light.
Data were analyzed using General Linear Model (GLM) procedure with each subject as his own control (light vs. no-light) & Tukeys HSD multiple
comparison test ( = 0.05) using patients average shade 1 week after bleaching less their average shade initially. (Choice of subjects yielded 162 pairs
of teeth, but 11 pairs were excluded from analysis due to initial shades not being the same, resulting in 151 pairs in the analysis.)

B. CLINICAL TOOTH LIGHTENING RESULTS

Graph below shows 1-week post-bleach tooth lightening results by bleach system with & without use of light. One week post bleach shades were used
to allow ample time for rehydration of teeth following treatment. Vertical bars show change in Value & Chroma for each system. Horizontal bars
indicate systems with similar cumulative results.
Amount of Tooth Color Change on Vitapan 3D- Master Shade Guide
Average Shade Change 1 Week After Bleaching

2.0 *
1.8 1.8
KEY:
1.7 1.7 Light (Chroma) No-Light (Chroma)
1.6 1.6 * *
1.5 1.4 1.4 1.4
Light (Value) No-Light (Value)
1.3
1.2

1.0
1.1 1.1 1.1
* Products where light use is stated by
manufacturers as optional, & when
used a resin curing light is suggested.
(CRA used Optilux 500.)
0.5
BriteSmile is not included in this graph
because CRA clinical tests are not yet
completed.
0.0
Opalescence Rembrandt
Xtra Boost LumaArch Zoom PolaOffice Niveous Lightning LaserSmile
Plus
60 min. 24 min. 60 min. 16 min. 45 min. 60 min. 24 min.
41.5% 41% 28% 41% 27.2% 35.7% 36.7%
Product Name, Manufacturers Recommended Total Contact Time,
& CRA Assayed % H2O2 in the Mixed Gel

SUMMARY OF GRAPH:
The 3 systems where manufacturers designated light use as optional (Opalescence Xtra Boost, PolaOffice, Niveous) produced tooth lightening comparable to the
5 systems where use of light was mandated by the manufacturer.
Within each system individually, comparable lightening resulted whether or not light was used.
Although all systems lighten teeth an average of about 1 to 2 shades, proprietary chemicals now added to the H2O2 just before use allowed some bleach gels to
lighten teeth faster (LumaArch) & others to lighten teeth using less active ingredient (Zoom).
Statistically, LumaArch was among the 3 best performers & lightened teeth to the same degree as Opalescence Xtra Boost & Zoom systems, but achieved it in about
1/3 of the time (24 min. vs. 60 min.).
Possible reasons for less bleaching produced by 4 of the systems (see right to left in graph above):
LaserSmile gel is not activated chemically before application, & has a relatively short total contact time of 24 minutes.
Rembrandt Lightning Plus gel is activated chemically before application & its gel decomposition was so rapid that it may have dissipated much of its bleach
potential before it was applied to the teeth. In addition, it used a single gel application that stayed in place 60 minutes & was agitated, but not renewed.
Manufacturers newest directions now state: For best results, we recommend re-applying the gel every 15-minutes.
Niveous rate of gel decomposition after activation was lower than other activated gels, & the gel had less H2O2 at 27.2% & a little less contact time at 45 minutes.
PolaOffice was activated chemically before use & had good activity, but used 4 short contact times of 4 minutes each, for a total of contact time of only 16 minutes.

C. SENSITIVITY
Tooth sensitivity occurred with every system, & included teeth lightened with gel & light & with gel alone. These data suggest post treatment
sensitivity is due to the H202 gel, & not the current generation lights. All sensitivity resolved within 48 hours.

4. CONCLUSIONS
All systems tested lightened teeth & the degree of lightening depended on system chemistry & directions for use.
Opalescence Xtra Boost, LumaArch, & Zoom lightened teeth significantly more than the other 4 systems. Use of lights
according the manufacturers directions did not improve lightening for any system tested. Systems where light was stated
to be optional where any type of light could be used, lightened teeth as well as or better than, systems where light was
mandated & specific lights were sold as part of the system. The newest trend in in-office bleach gels is addition of chemical
activators to speed the lightening process (LumaArch) & reduce active ingredient (Zoom). Performance of LumaArch & Zoom,
respectively, exemplify these improvements. (CRA report on BriteSmile is forth coming.)
See CRA Website (www.cranews.com) for methods & complete data.
 CRA Newsletter Page 4 March 2003
CRA
CONFIRMED NOTEWORTHY
USEFUL

SELF ADHESIVE CUSHIONS WRAP FILM EDGES FOR BETTER PATIENT COMFORT
EDGE EASE
Disposable cushions cover edges & wrap corners of x-ray film packs & digital
sensors. 2 styles (anterior-white, posterior-blue). Can be used with x-ray
alignment devices. Advantages: (1) Covers sharp edges & corners for
improved patient comfort & easier placement; (2) Easy to use; & (3) Works
with both conventional film & digital sensors. Disadvantage: Adds time to
place & remove.
of 20 CRA Evaluators stated this product would replace products
$42 / Box of 300
Strong Products
2725 Hidden Hills Way Corona, CA 92882 U.S.A.
61% they use currently, & 90% rated it excellent or good & worthy of
trial by colleagues.
909-371-5185 800-648-9729 Fax: 909-371-1468
Website: www.strongproducts.com

CASE PRESENTATION TRAINING

ISNT IT WONDERFUL WHEN PATIENTS SAY YES
Multi media training package for dental team to improve staff communication
with patients & increase full-case acceptance. Includes 348 page hardback
book, 4 CDs (1 hour each), & 2 VHS tapes (1 1/2 hour each). Advantages:
(1) Excellent presentation; (2) Helpful information; & (3) Good use of multi
media. Disadvantages: (1) Cost, & (2) Condensed version of book desired by
some. NOTE: System components can be purchased separately.
of 21 CRA Evaluators stated this product would replace products
$129.00 / System
Homoly Communications Institute
127 W. Worthington Ave. #200 Charlotte, NC 28203 U.S.A.
57% they use currently, & 71% rated it excellent or good & worthy of
trial by colleagues.
704-342-4900 800-294-9370 Fax: 704-342-4995
Website: www.paulhomoly.com

PALATE-FREE COLOR CODED FULL ARCH IMPRESSION TRAY

ORIGINATE
Upper Lower
Disposable rigid trays with retentive features for use without adhesive for any
impression material including alginate. Lower & upper arches in 3 sizes (S,M,L).
Individually wrapped with identification tag. Advantages: (1) Color coded;
(2) Strong & rigid; (3) I.D. tag attaches easily; (4) Maxillary trays caused less
gagging; & (5) Retained impression material well. Disadvantages:
$10.80/ Bag of 12 (One size, one arch) (1) Posterior too narrow for some, & (2) Cost. Some Evaluators reluctant to
use for crown & bridge while others indicated successful use.
Axis Dental Corporation
of 20 CRA Evaluators stated this product would replace products
3008 West Story Rd. Irving, TX 75038 U.S.A.
972-536-6000 800-355-5063 Fax: 972-257-3647
Website: www.axisdental.com 55% they use currently, & 86% rated it excellent or good & worthy of
trial by colleagues.

TOPICAL ANESTHETIC GEL GIVES LONGER ANESTHESIA

ONETOUCH
Topical anesthetic gel containing benzocaine (18%) & tetracaine HCl (2%)
in unique pump style dispenser jar with screw on/off top & 5 flavors.
Advantages: (1) Fast acting profound topical anesthesia with good duration;
(2) Easy to dispense amount desired to minimize waste; (3) Dispenser does
not leak if overturned or left on its side; & (4) Good flavors & consistency.
Disadvantages: (1) Cannot work dispenser easily with 1 finger or cotton tip
$11.90 / 30g jar applicator, & (2) Cost.
Hagar Worldwide of 21 CRA Evaluators stated this product would replace products
13322 Byrd Dr. Oddessa, FL 33556 U.S.A.
813-926-7474 800-328-2335 Fax: 813-926-7473
Website: www.hagerworldwide.com
57% they use currently, & 86% rated it excellent or good & worthy of
trial by colleagues.

Products evaluated by CRA & reported in the CRA Newsletter have been selected on the basis of merit from hundreds of products under evaluation. CRA conducts research at 3 levels: (1) Multiple-user field
evaluations, (2) Controlled long-term clinical research, & (3) Basic science laboratory research. Over 400 clinical field evaluators are located throughout the world & 48 full-time employees work at the institute. All
professional staff volunteer their time. A product must meet at least one of the following standards to be reported in this publication: (1) Innovative & new on the market; (2) Less expensive, but meets the use
standards; (3) Unrecognized, valuable classic; or (4) Superior to others in its broad classification. Your results may differ from CRA Evaluators or other researchers on any product because of differences in
preferences, techniques, batches of products, & environments. Clinical Research Associates, Inc. (CRA ) is a non-profit educational & research corporation using a unique volunteer structure to produce objective,
factual data. All proceeds are used to support the work of CRA & the CRA Foundation, a tax exempt foundation. 2003 Clinical Research Associates, Inc. This Newsletter or portions thereof may not be
duplicated without permission of CRA. Annual English subscription $58 in U.S. & $60 (U.S. Funds) in other languages &/or countries, or $7 per issue.