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Volume 26, Issue 4
CRA
FIRST LOOK
April 2002
INVISIBLE MOVEMENT OF FULLY ERUPTED TEETH
Esthetic tooth movement without traditional brackets & bands for fully erupted permanent teeth can
now be accomplished using a series of custom removable plastic “Aligners” similar in appearance
to fluoride & bleaching trays. The number of Aligners depends on the complexity of the case
(average 10-30 Aligners per case). The concept has been around since the late 1940’s but a
commercially available product was marketed in 1998 only to orthodontists, & is now available to all
dentists. Below CRA “First Look” report gives: (1) Product information; (2) Sequence of treatment;
(3) Case selection indication & contraindication guidelines; (4) Advantages & disadvantages;
(5) Patient’s clinical observations; & (6) CRA conclusions.
IN
THIS
ISSUE:
• ESTHETIC
MOVEMENT OF
FULLY ERUPTED
TEETH
1.
INVISALIGN
COSTS:
Pages 1-2
$1,100 - $1,800 per case based on number of teeth treated, &
without the required 1-time certification charge or optional service
costs.
Following shows itemized costs:
• “MAINTENANCEFREE”
HANDPIECE
TURBINES
Required—1-time 8 hour certification course for 1 dentist & up to 3 staff on marketing, case selection, treatment
planning, case submission, & case management. $995
Required—Case confirmation, treatment review, Aligner production & delivery
Full arch treatment: 1 arch $1,300; upper & lower $1,800
Canine to Canine: 1 arch $1,100; upper & lower $1,500
Pages 3-4
Optional—Case refinement additional Aligners for mid-course or final adjustments not anticipated initially.
$ 50 if purchased at start of procedure & covers 1 refinement orders at no additional cost.
$ 250 if not purchased at start of procedure or if more than 1 refinement ordered.
• CPR EZY
CPR kit with
unique timer
Optional—Post treatment retainers made of thicker polyurethane used as night retainer.
$ 50 per retainer.
Page 4
SOURCE: Align Technology • 851 Martin Avenue • Santa Clara, CA 95050 U.S.A.
Telephones: 888-822-5446 & 408-470-1000 • Fax: 408-470-1010
Website: www.invisalign.com
DESCRIPTION: Progressive series of clear, rigid, polyurethane pressure formed Aligners (0.762 mm / 0.030 inches
thick) to incrementally move teeth about 0.25 mm per tray.
2.
SEQUENCE OF TREATMENT
Sequence below shows steps required to provide treatment to patients using Invisalign.
Dental Team
TM
Since
1976
3707 N. Canyon Road #6
Provo, Utah 84604
801-226-2121
w w w. c r a n e w s . c o m
Align Technology
Dental Team
• Secure certification.
• Confirm via internet case was • Dispense patient initial Aligners.
• Diagnose case.
received from dentist.
-Patient wears each Aligner about
• Select case.
• Prepare
3D
animation
of
22 hours per day for about 2
• Submit following to Align Technology:
treatment (ClinCheck) & post on
weeks per Aligner.
-Intraoral & extraoral photographs.
internet for dentist’s review, • Appoint patient to evaluate
-Poly vinyl silicone impression
modification, & acceptance.
progress after use of each series
& bite registration.
• Produce Aligners & send to dentist.
of Aligners dispensed by office.
-Panoramic or intraoral x-ray series.
• Maintain including using retention
-Complete treatment planning
protocol.
form
including
treatment
planning objective.
• Secure
patient
commitment
& consent.
“CLINICAL SUCCESS IS THE FINAL TEST.”
CRA Newsletter
3.
Page 2
April 2002
CASE SELECTION INDICATION & CONTRAINDICATION GUIDELINES
Align Technology indicates Invisalign can treat most conditions, but dentists using Invisalign offer the following:
Indications:
Not advised:
Contraindications:
• Anterior alignment in preparation for restorative work
• Anterior crowding (mild to moderate)
• Diastema closure
• Midline adjustments up to 2 mm
• Minor crowding or spacing without vertical problems
• Minor tipping & rotation such as present in
orthodontic relapse cases
• Normal or acceptable bite relationship with mild to
• Bicuspid extractions
• Class 2 & 3 malocclusion
• Derotation of cylindrical teeth
• Excessive overjet & overbite
• Extreme crowding
• Extrusion
• Major cross bite
• Severe open bite
• Active perio
• Active TMD
• Major cross bite
• Mixed dentition
• Restortive dental work required
• Short clinical crowns
• Skeletal abnormalities
moderate spacing or crowding
• Spacing realignment (opening or closing) less than
4 mm in a single location
• Single tooth anterior crossbite
• Space redistribution in preparation for restorative work
4. ADVANTAGES:
DISADVANTAGES:
Data below are from 5 orthodontists, 12 general dentists, & 11 patients participating in Invisalign treatments.
A. More esthetic since Aligners are virtually invisible. A. Learning curve for case selection can be long due to
time needed to follow cases through completion.
B. Less chair time for patient.
B. Results & length of procedure depend on number of
C. Removability aids oral hygiene, both at home & in
trays, close patient treatment monitoring by dentist,
dentist’s office.
& patient compliance.
D. Avoids problem of white spots & decay common
C. Cost of materials is substantially higher to clinician
with conventional orthodontic treatment due to
than same case treated conventionally.
retention of plaque by fixed attachments.
D. Does not allow fine movement near case completion,
E. More comfortable than traditional appliances.
which is available with brackets & wire.
F. Simple & easy.
E. Treatment delay between patient commitment & start of
H. Increases interest in ortho among adult patients.
treatment can be experienced (4-6 weeks). Lag is due
to time for review, approval, treatment planning by
I. State-of-art in cosmetic orthodontic treatment.
dentist, production, & shipping of Aligners.
J. Metal free orthodontic option for those with nickel
F. Ideally, dental maintenance treatment should be
sensitivities.
completed before Aligners are made.
K. Avoids abrasion on facial surface associated with
G. Dentist must store & keep track of Aligners not yet
debonding procedures, particularly with ceramic
given to patients for cases in progress.
brackets.
H. Maintenance of completed cases is a life-time commitment,
L. No emergency appointments due to debonds or
for both dentist & patient. As with all orthodontics,
broken wires.
records must also be retained.
5. PATIENT CLINICAL OBSERVATIONS
Responses below are from 11 patients who have used Invisalign for 9 to 24 months:
A. Somewhat painful for the first 1 to 3 days after placing
each new Aligner.
B. Minimal soft tissue irritation, minimal interference with
speech, & minimal increase in salivation noted due to
Aligners.
C. No increase in breath malodor noted.
D. Requires strict compliance to regimen to obtain desired results
in projected time frame. Due to this point, use may be best
in adults.
E. Most patients rated experience excellent to good.
F. 82% would use Invisalign again. Reasons given for not
using Invisalign again were cost (9%) or compliance
responsibility (9%).
G. 82% stated end result met expectations.
H. 82% broke or lost at least one Aligner. Dentists advised
that they move onto next Aligner in series without
trying to replace broken or lost Aligner.
6. CRA CONCLUSIONS
Invisalign provides dentists an esthetic orthodontic option for patients who may not consider
conventional orthodontics because they do not want to wear orthodontic appliances. Invisalign
has limited application & case selection is critical. Compared to conventional orthodontics for
comparable cases, cost to clinician is higher & treatment time may be longer, but so far patient
satisfaction has been generally high. As with all orthodontic treatment, use of some type of
alignment maintenance is necessary & is a lifetime commitment for both the dentist & patient.
See CRA Website (www.cranews.com) for pertinent literature review.
CRA Newsletter
CRA
FIRST LOOK
Page 3
April 2002
NO-LUBE HIGH-SPEED HANDPIECE TURBINES
Lubrication of handpieces (HP’s) before each patient use & /or sterilization has caused the following unanticipated
& unavoidable problems:
(1) Deposition of lubricant onto freshly cut dentin which interferes with adhesive dentistry.
(2) Prolonged handling of septic HP’s which compromises aseptic technique.
(3) HP rpm slow-down due to internally baked-on build-up of lubricant.
(4) Exterior discoloration of HP’s, making them appear unclean to patients.
(5) Increased costs to purchase, apply, & clean-up lubricant multiple times each day.
To respond to these problems, “maintenance-free” turbines were developed. In 1991, DentalEZ introduced the
concept for their Star 430 HP. Recently, Timken has further developed the concept for all major HP brands.
CRA’s “First Look” report compares performance of the new turbine to those sold currently in two popular HP’s.
1.
MAINTENANCE-FREE DYNAMIC PERFECTION TURBINE
COST:
$69 to $219, depending on HP brand. See website www.handpieceheadquarters.com or
www.score-ez.com for current listing of HP’s & prices of replacement turbines. Currently,
Maintenance-Free Turbines are not available for KaVo 635, 647, & 649, & some Bien Air HP’s.
SOURCES: Handpiece Headquarters • 2284 North Galasell Street, Unit A • Orange, CA 92865 U.S.A.
Telephones: 714-685-3070 & 800-557-7867 • Fax: 714-921-1852
Score International, Inc. • 801 Central Park Drive • Sanford, FL 32771 U.S.A.
Telephones: 407-322-3230 & 800-726-7365 • Fax: 407-330-0919
DESCRIPTION: Turbines with stainless steel bearings lubricated by the manufacturer that do not require
lubrication by dental staff.
2.
STUDY DESIGN
(A) REPORT
•
•
•
•
CODES FOR 4 HP / TURBINE COMBINATIONS EVALUATED
Midwest-MAINTENANCE-FREE: Midwest XGT HP with Maintenance-Free Turbine (metal bearings never lubricated by the clinician).
Midwest-Lube: Midwest XGT HP with Dentsply Midwest turbine (metal bearings lubricated before each sterilization by the clinician).
Star-MAINTENANCE-FREE: Star 430 HP with Maintenance-Free Turbine (metal bearings never lubricated by the clinician).
Star-Lube-Free: Star 430 HP with DentalEZ turbine (ceramic bearings never lubricated by the clinician).
(B) CRA LAB TEST METHODS
• 12 HP’s (6 Midwest XGT & 6 Star 430) were cycled until failure with their factory-installed turbines, & subsequently with the Maintenance-Free Turbines.
• One HP test cycle included: cut on bovine tooth for 60 seconds; clean HP (all HP / turbine combinations) & lubricate HP per manufacturer’s
recommended steps (Midwest-Lube only); & sterilize.
• HP failure was defined as anything that rendered the HP unusable clinically, such as bur would not rotate, chuck would not hold or release
bur, severe non-concentric operation, HP body integrity defect, or power (torque) below 5 watts.
• 6 HP’s of each brand were divided randomly by serial number into 2 sterilization groups & sterilized in steam or chemical vapor sterilizers.
• All HP’s were tested for “torque” (watts) before the first cycle & after every 100 cycles.
CRA TEST RESULTS & COST ANALYSIS
Important considerations in deciding whether to continue using turbines that must be lubricated before each use or
switching to a new no-lube Maintenance-Free Turbine are: (A) Longevity & Cutting Ability & (B) Costs. Below are
results of CRA tests related to these points.
A. LONGEVITY & CUTTING ABILITY
Longevity is demonstrated by a HP’s ability to operate well clinically, regardless of the number of uses
& time sterilized. Cutting ability is demonstrated by a HP’s power (referred to as “torque” by most dentists).
Figure 1: Longevity & Cutting Ability Comparison
Midwest-MAINTENANCE-FREE (45 psi*)
Midwest-Lube (35 psi)
Star-MAINTENANCE-FREE (34 psi)
Star-Lube-Free (34 psi)
20
POWER (WATTS)
3.
SUMMARY OF GRAPH:
Midwest XGT: Maintenance-Free Turbines operated about half as
long as those lubricated after each use which are sold in
Midwest XGT HP’s, but showed similar power throughout
testing during repeated use & sterilization.
Star 430: Maintenance-Free Turbines & the turbines sold in Star 430
HP’s had comparable longevity & power throughout testing
during repeated use & sterilization.
15
10
5
0
100
200
300
400
500
600
AVERAGE NUMBER OF USES
* Directed by Handpiece Headquarters to increase psi from 35 to 45 psi to improve cutting ability.
700
CRA Newsletter
Page 4
April 2002
B. COSTS
Costs associated with cleaning, lubricating (if required), & replacing turbines were calculated over 1200 uses, extrapolating data
from Figure 1. Graph below shows possible costs once the turbine fails if the manufacturer’s original turbine is replaced with the
Maintenance-Free Turbine or a manufacturer’s turbine.
Figure 2: Replacement Turbine Cost Comparisons
2500
GRAPH LEGEND:
Midwest-MAINTENANCE-FREE ($189 / turbine; push button chuck)
Midwest-Lube ($226 / turbine; push button chuck)
COST ($)
2000
Direction
of
slope
indicates mounting costs
of lubricant & time spent
cleaning after each use.
Star-MAINTENANCE-FREE ($199 / turbine; push button chuck)
Star-Lube-Free ($285 / turbine; push button chuck)
1500
SUMMARY OF GRAPH: Maintenance-Free Turbines are less
expensive to purchase new, but must be replaced more frequently
than Midwest & Star factory-installed turbines. Over time, costs of a
Maintenance-Free Turbine & HP company’s factory-installed turbines
become comparable for both Midwest XGT & Star 430 HP’s.
1000
500
0
Vertical steps indicate
replacement turbine
costs.
200
400
600
800
1000
1200
NUMBER OF USES
C. CLINICAL OBSERVATIONS USING MAINTENANCE-FREE TURBINES
CRA clinical evaluation showed performance of Maintenance-Free Turbines is HP brand dependent.
Midwest XGT
Star 430
• Excellent torque.
• Quiet operation.
• Bearing malfunction was the eventual cause
• Excellent torque.
• Quiet operation.
• 5 of 6 HP’s demonstrated push button chuck problems
of failure of all 6 Maintenance-Free Turbines.
4.
(3 were cycled in steam & 2 in chemical vapor). These
problems were sporadic & random at first, becoming
more constant under continual use.
• 4 of 6 Maintenance-Free Turbines failed due to a bearing
malfunction (2 in steam & 2 in chemical vapor).
The other 2 turbines failed due to chuck failures.
CRA CONCLUSIONS:
The Maintenance-Free Turbine, now available for most major HP brands, eliminates clinical HP lubrication & the
five associated lubricant problems listed at the beginning of this report. “Maintenance-free” technology is a long
overdue feature in HP design. Data above from CRA tests indicate that the current design Maintenance-Free Turbine
is clinically practical. Performance is comparable too, but not superior to Midwest XGT & Star 430 factory-installed turbines.
See CRA Website (www.cranews.com) for test methods & full data from testing.
CRA
CONFIRMED
USEFUL
NOTEWORTHY —
CPR KIT PROVIDES EXCELLENT SUPPORT FOR LESS EXPERIENCED RESCUERS
$199.95 / kit
CPR EZY
CPR EZY pad is positioned on patient’s sternum, gives audible beeps to guide the
correct rate of chest compressions, & has an LED that illuminates with appropriate
compression. Face mask helps keep victim’s oral airway open & nasal airway closed,
while protecting the rescuer from victim’s oral fluids with a one-way valve mouthpiece.
Advantages: (1) Clear instructions including poster, CD, & video; (2) Easy to use; (3)
Helps guide proper CPR pressure & rhythm; (4) Excellent mask; & (5) Excellent CPR
training & re-training aid. Main disadvantages were cost & no prompt included for
breathing. (This product does not replace CPR training & certification.)
MedTeq Solutions
20280 N. 59th Ave • Suite 115-PMB #442
Glendale, AZ 85308 • U.S.A.
623-869-7977 • Fax: 623-869-7974
email: [email protected]
75%
of 20 CRA Evaluators stated this product would replace products they use
currently, & 80% 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; & (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. ©2002 Clinical Research Associates, Inc. This Newsletter or portions thereof may not be
duplicated without permission of CRA. Annual English subscription $57 in U.S. & $59 (U.S. Funds) in other languages &/or countries, or $7 per issue.