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WORK ORDER #1
SPONSOR INFORMATION
Sponsor name: Reliance Orthodontic Products, Inc.
Sponsor Address: 1540 West Thorndale Ave
Itasca, IL 60143
Contact person: Mr. Paul Ganges
Title: President
Voice: (630) 773-4009
Mobile: (630) 546 4477
Email: paulgropi@aol.com
(note: Simultaneously click the CONTROL button and select a topic with the mouse
Left button to be taken directly to that location in the proposal body)
STUDY PURPOSE.......................................................................................................... 3
Objective...................................................................................................................... 3
CONCLUSIONS ............................................................................................................ 30
The manuscript is the final report of the above referenced project work order and title,
and represents the completion of all aspects of the proposed study, as it was outlined in
the original experimental protocol delivered at contract signing.
STUDY PURPOSE
This project was designed to compare the ability of a Reliance Orthodontic enamel
sealant (L.E.D. Pro Seal) and a competitive product (Opal Seal, by Ultradent
Products) to resist tooth brushing using an in-vitro testing model. Specifically,
clinically relevant placement of each type product was made on the flattened surface
of bovine enamel. Specimens were subjected to long-term tooth brush abrasion in a
V-8 brushing machine, and the cross-sectional thickness at a reproducible location
of each type product was measured and compared at specific times into brushing, to
simulate durations of clinical tooth brushing.
Objective
To measure and compare the amount of vertical sealant loss within a defined
location after various durations of simulated toothbrush abrasion between two
commercial brands of enamel sealants: Opal Seal and L.E.D. Pro Seal.
STUDY METHODS
Enamel sealants tested
A table of the enamel sealants used is listed below.
Table 1
Enamel sealant products tested
20
10
0
350 375 400 425 450 475 500 525 550
WAVELENGTH (nm)
Figure 1
Spectral irradiance of light curing unit used in the testing (Elipar S10, 3M/ESPE)
Specimen Fabrication
Tooth preparation
The facial surface of a lower bovine incisors having a large mesio-distal
measurement were flattened to 320 grit SiC on a water-cooled, rotating, flat surface.
The crown segment was then removed from the root portion, and was trimmed to fit
within the recess of a custom-made, polymer matrix. Undercuts were placed in the
The tooth/matrix assembly was placed on the table of a micro-drill press to create
two small, shallow (about 300-micron deep) semi-circular depressions at the lateral
sides of the exposed, flattened enamel surface.
COMPOSITE MATRIX
EXPOSED, FLATTENED
ENAMEL SURFACE
SHALLOW DIMPLE
USED FOR HEIGHT
REFERENCING
Figure 2
Diagram of embedded tooth and reference dimples
DIGITAL CROSS-
SECTION ANALYZED
Figure 3
Depiction of area to be surface profiled (red outlined area), and the cross-sectional
plane to be analyzed on all future scans (blue dashed line)
Empress (A2)
Figure 4
Diagram of cross section depicting the plane connecting the bottoms of the two small
lateral dimples – obtained using computer software from profile scans (see Fig 2
I. blue-bashed line)
Specimen Motion
II.
Scanning probe
Figure 5
Surface profiling system
ENAMEL
400
300
200
HEIGHT (microns)
100
0
0 2000 4000 6000 8000 10000
-100
-200
-300
-400
WIDTH (microns)
Figure 6
Example of an actual scan of a polished, dimpled enamel surface used in the
experiment
The proper amount of unpolymerized enamel sealant was applied to the etched area
in a manner simulating exactly how this material is applied clinically, following
manufacturer’s instructions for each product. The applied material was then light-
cured using manufacturer-recommended exposure durations: 10 seconds.
Care was taken to NOT place any material into the two shallow, reference dimples
made in the enamel surface on the lateral sides of the flattened tooth surface.
Immediately after polymerization, the surface of each applied sealant was gently
wiped with a cotton gauze to remove any trace of oxygen inhibited layer, even
though the manufacturer might have indicated that none exists.
Empress (A2)
Figure 7
Diagram of a cross sectional analysis of scan connecting bottoms of the two dimples
after placement of the enamel sealant
Using the software, the height and area of the sealant in the plane connecting the
bottoms of the two shallow dimples was determined, and the area of resin (as well as
its vertical height) was determined, using the depths of the bottoms of the two
dimples as consistent vertical references.
Figure
Empress (A2) 8
Diagram showing how the height of the thin enamel sealant film was be determined
An actual example of the overlay of the flattened enamel surface and the freshly
applied enamel sealant is seen in the following figure.
400
300
200
HEIGHT (microns)
100
0
0 2000 4000 6000 8000 10000
-100
-200
-300
-400
WIDTH (microns)
Figure 9
Overlay graph indicating both the enamel surface prior to sealant placement and the
same location after sealant placement and light-curing.
Note: green line is flattened tooth surface, red line is the outside profile of the actual
layer of sealant applied to the underlying enamel
Specimen Testing
Toothbrush abrasion machine
Freshly prepared specimens were placed into custom-made matrix mounts and
special protective, metal bands were fastened around the girth of each specimen,
covering the location where the two lateral dimples were located, as well as a small
amount of sealant on either side. In this manner, the dimpled areas were protected
from toothbrush abrasion.
Toothbrush
Head
Specimen holder
holmaterial
Sealant
Protected Dimple
Tooth
Enamelspecimen
Surface
Figure 10
Diagram of protective sleeve placed around the specimen holder matrix in order to
protect the shallow dimple from toothbrush abrasion. Note that a portion of the lateral
sealant was also protected from wearing.
Toothbrush
Motion
Figure 11
Photographs of the tooth brushing machine used and close-up of the tubes containing
the water slurry of paste
Table 2
Intervals of brushing at which specimen profile readings will be obtained
Note, new toothpaste solutions were applied to all brushing stations on a simulated
yearly basis: after years 1 and 2.
100
0
0 2000 4000 6000 8000 10000
-100
-200
-300
-400
WIDTH (microns)
Figure 12
Overlay graph of the same enamel sealant (Opal Seal) cross-sectional profile
obtained at each time interval of tooth brushing at a specific tooth brushing test
station.
At times, sealant loss was noted to the extent that the underlying enamel was
exposed, which also was wearing. Areas on the tooth surface where sealant had
totally been worn away needed to be eliminated from the analysis. The following
figure demonstrates how such an occurrence was dealt with, by judiciously selecting
only the horizontal length of area where sealant loss was noted, but not to the level
of enamel exposure.
0
0 2000 4000 6000 8000
-100
-200
-300
-400
WIDTH (microns)
Figure 13
Example showing how the horizontal area of sealant wear analysis was restricted to
only that region (between 2400 and 4200 microns) that still had sealant present after
36 months of simulated tooth brushing.
400
ENAMEL
FRESH SEALANT
300
3 MONTHS
200
HEIGHT (microns)
100
0
0 2000 4000 6000 8000 10000
-100
-200
-300
-400
WIDTH (microns)
Figure 14
Example showing how the loss of cross sectional area was determined between
when all the sealant was present (red line), and after the first 3 months of simulated
tooth brushing (blue line), from the reference plane of the initial flat enamel surface
(green line). NOTE – only within the light green rectangle were areas determined.
This difference value in areas between the freshly placed sealant and that measured
after a specific number of simulated tooth brushing times was then divided by the
number of simulated number of months that had accumulated up to the point of the
wear profile scan, to determine a monthly vertical sealant loss: square
microns/month.
Table 3
ANOVA report for the 2-way, repeated measures test examining the effect of sealant
type and duration of tooth brushing on wear of sealant.
Source of Variation DF SS MS F P
PRODUCT x
7 4831849.308 690264.187 3.746 0.003
MONTHS TBA
These findings indicated that both the major factors of product tested as well as
duration of tooth brushing had a significant influence on the wear rate of sealants. In
addition, there was a significant (p = 0.003) interaction term between the two main
variables. After further analysis, it became obvious that the interaction term that
9000
8000
y = 50.049x + 5170.9 R2 = 0.278534
LOSS RATE (square microns/month)
7000
6000
5000
1000
0
0 5 10 15 20 25 30 35 40
SIMULATED DURATION OF TOOTH BRUSHING (MONTHS)
Figure 15
Rate of vertical sealant loss of Opal Seal over scanned line (square microns/month)
Each data point represents average of 4 experimental runs
Vertical bars represent +/- 1 standard deviation
Equation represents the linear regression of the experimental data
As can be seen, there is an increasing loss of vertical sealant area with accumulated
tooth brushing. During the first three months of simulated brushing, the product lost
the greatest amount of material, and thereafter lost surface area at a linear rate.
Linear regression analysis was performed on the experimental data (not forcing the
2000
PROSEAL
LOSS RATE (square microns/month)
Linear
1500
(PROSEAL)
y = 4.6009x + 691.88 R2 = 0.3816
1000
500
0
0 5 10 15 20 25 30 35 40
SIMULATED DURATION OF TOOTH BRUSHING (MONTHS)
Figure 16
Rate of vertical sealant loss for L.E.D. Pro Seal over scanned line (square
microns/month)
This plot seems to indicate that once the initial wear of L.E.D. Pro Seal has occurred
within the first three to 6 months (the greatest time of wearing), the rate at which the
sealant wears does not seem to change with accumulated duration of tooth brush
abrasion. The overall rate of loss of vertical sealant surface averages only about
one-fifth that found with Opal Seal, and is around 4.6 square microns per month.
Substantiating the observation that the rate of L.E.D. Pro Seal wear does not seem
to change with time is the fact that the slope of the regression line is not significantly
different from zero: having a p-value of 0.3618 (recall, values less than 0.05 would
indicate a significant trend of sealant loss with accumulated tooth brushing).
8000
y = 50.049x + 5170.9 R2 = 0.278534
LOSS RATE (square microns/month)
7000
6000
5000
3000 PROSEAL
Figure 17
Overlay of the rates of wear of Opal Seal and L.E.D. Pro Seal at similar durations of
simulated tooth brushing.
When placing these two loss profiles on the same coordinate scales, the greater loss
rate associated with Opal Seal becomes very apparent. In the figure, the increasing
loss rate with accumulated brushing of Opal Seal can be seen, and the unchanging
nature of the loss of L.E.D. Pro Seal is apparent.
The Tukey post-hoc test, comparing differences in mean wear rates between the two
commercial enamel sealants at similar durations of simulated tooth brushing
indicated that, for every time interval measured, the wear rate of Opal Seal was
significantly greater (p<0.05) than that of L.E.D. Pro Seal.
Normalizing Results
Because of differences in viscosities between the two sealant types, one product
consistently left an average thicker layer than did the other: average peak thickness
of Opal Seal was 265 ±43 µm and that of LED Pro Seal was only 111 ±33 µm.
Using an unpaired, 2-tailed Student’s t-test, these values were proven to be
significantly different: p = 0.0016.
To make a more even “playing field” between the two materials, the cross sectional
wear patterns of all specimen runs were adjusted so that only the top 100 microns
was seen. This method created equivalent sealant layer thickness of approximately
100 microns for each run: all data below that level was ignored. The top-most 100
microns cross section of each freshly applied sealant was then plotted as well as
that after 9 and 36 months of simulated tooth brushing. This process was performed
to see if, after these time intervals of brushing, any of the lateral sealant (where it
was thinner) would have been worn through, and exposed the underlying enamel. If
so, then this meant that, subsequent to these time periods, this area, and more
lateral areas would be unprotected by the sealant. The following figures present the
top-most 100 microns of actual data runs for each specimen, showing differences
between the profile of the freshly placed sealant and its profile after 9 and 36 months
of simulated tooth brushing.
310
300
290
HEIGHT (microns)
280
270
260
250
240
230
220
210
3000 4000 5000 6000 7000
WIDTH (microns)
Figure 18
Overlay of top-most 100 microns of fresh sealant and sealant after 9 and 36 months
of simulated tooth brushing wear: Opal Seal testing station #1.
Note two things in this Figure. Firstly, the large amount of sealant lost from the 9
months of tooth brushing, as well as the fact that, after this time period, one side of
the enamel sealant would be gone, and would have exposed a lateral border of
enamel 100 microns in width that would no longer be protected. After 36 months of
simulated brushing, very little of the initial 100-micron thick sealant layer is still
present, leaving much of what would have been the underlying enamel surface
uncovered, and unprotected.
260
HEIGHT (microns)
240
220
200
180
160
1500 2000 2500 3000 3500 4000 4500 5000
WIDTH (microns)
Figure 19
Overlay of top-most 100 microns of fresh sealant and sealant after 9 and 36 months
of simulated tooth brushing wear: Opal Seal testing station #2.
Again, the large amount of sealant loss at the 9-month mark is noted in this profile,
as well as the fact that about 300 microns of sealant would have been lost bilaterally
(red circled areas) and exposed underlying enamel on either side of the sealant.
After 36 months of simulated brushing, only a few isolated area still retain sealant,
leaving most of the originally covered enamel without protection.
210
200
190
HEIGHT (microns)
180
170
160
150
140
130
120
110
2000 3000 4000 5000 6000 7000
WIDTH (microns)
Figure 20
Overlay of top-most 100 microns of fresh sealant and sealant after 9 and 36 months
of simulated tooth brushing wear: Opal Seal testing station #4.
As seen before, there is a large amount of vertical sealant loss at the 9-month mark.
About 300 microns of sealant would have been lost laterally (red-circled area),
exposing underlying enamel on one side of the sealant. After 36 months of simulated
brushing, only a small fraction of the original sealant that covered the enamel
surface remains.
272
262
252
HEIGHT (microns)
242
232
222
212
202
192
182
2000 3000 4000 5000 6000
WIDTH (microns)
Figure 21
Overlay of top-most 100 microns of fresh sealant and sealant after 9 and 36 months
of simulated tooth brushing wear: Opal Seal testing station #7.
As is typical, the large amount of vertical sealant loss at the 9-month mark is
evident. In addition, the two lateral sides of the sealant have each lost 300 microns
(red circled areas), which would have exposed this amount of enamel on the lateral
border of the initially place sealant. At the 36 month mark of simulated brushing, only
about a total of 25 of the originally covered enamel would be protected by the
remaining sealant: over 75% of the once-covered enamel would have become
unprotected.
105
90
HEIGHT (microns)
75
60
45
30
15
2000 3000 4000 5000 6000
WIDTH (microns)
Figure 22
Overlay of top-most 100 microns of fresh sealant and sealant after 9 and 36 months
of simulated tooth brushing wear: L.E.D. Pro Seal testing station #3.
In contrast to the profiles above seen of the Opal Seal product, note the very small
amount of vertical sealant loss between initial sealant placement and that observed
after 9 months of simulated tooth brushing. In addition, note that, at the lateral
borders (simulating where the sealant periphery is thin and in contact with the
enamel), little-to-no sealant loss is noted. This finding means that the enamel
remains protected and covered by the sealant at the restoration periphery. Note, as
well that, after even 36 months of simulated brushing, none of the sealant is lost at
130
120
110
HEIGHT (microns)
100
90
80
70
60
50
40
30
2000 3000 4000 5000 6000
WIDTH (microns)
Figure 23
Overlay of top-most 100 microns of fresh sealant and sealant after 9 and 36 months
of simulated tooth brushing wear: L.E.D. Pro Seal testing station #5.
The same trend of this product showing very little vertical sealant loss after 9 months
of simulated tooth brushing is seen, as well as little-to-no loss at the sealant
periphery. After 36 months of simulated brushing, only a small portion of one side of
the sealant is seen to be lost: approximately 200 microns. However, about 95% of
the remainder of the enamel surface would have been covered and protected.
120
110
100
HEIGHT (microns)
90
80
70
60
50
40
30
2000 3000 4000 5000 6000 7000
WIDTH (microns)
Figure 24
Overlay of top-most 100 microns of fresh sealant and sealant after 9 and 36 months
of simulated tooth brushing wear: L.E.D. Pro Seal testing station #6.
Once again, relatively little sealant loss is noted, and occurs at the very top center of
the material. No loss is noted at the sealant border, indicating protection of the
underlying enamel throughout this time period. At the 36-month mark, only a small
portion of one lateral border indicates loss of sealant. Once again, however, 95% of
the originally covered enamel surface remains protected by a continuous, large layer
of sealant.
60
50
HEIGHT (microns)
40
30
20
10
0
1000 2000 3000 4000 5000
WIDTH (microns)
Figure 25
Overlay of top-most 100 microns of fresh sealant and sealant after 9 and 36 months
of simulated tooth brushing wear: L.E.D. Pro Seal testing station #8.
As was seen previously, at the 9-month time mark, relatively little vertical sealant
loss is noted, and occurs only at the very top center of the material. Note that this
specimen, after application, was only about 63 microns thick. This means that the
material at the lateral portions is even thinner than with the other specimens. Thus,
this specimen tends to show slight traces of sealant loss at the periphery: only about
50 microns on each side. After 36 months of wear, there is about 200 micron loss of
peripheral sealant on the left side: a similar finding in other specimens noted above.
CONCLUSIONS
The major objective of this study was to evaluate the relative rates of surface wear
between the two test enamel sealant products. The results strongly indicated that
L.E.D. Pro Seal wore at a remarkably lower rate than did one of its competitors: Opal
Seal. For both sealants, the most wear occurred during the first three months of
simulated brushing, but even at that time point (and at every time point thereafter),
the rate of sealant loss of L.E.D. Pro Seal was remarkably lower than that of Opal
Seal. In fact, after the initial 3-month duration, Opal Seal continued to have an
increased wear rate with time (approximately 50 square microns a month), while the
wear rate of L.E.D. Pro Seal (measured at only 4.6 square microns per month) did
not significantly increase between 3 months and 36 months of simulated tooth brush
abrasion.
In an attempt to normalize wear findings among all products and specimens, just the
top-most 100 microns of sealant were evaluated for wear, between the time of initial
sealant placement, and after 9 or 36 months of simulated tooth brushing. In this
manner, the results could be associated with placing all materials in a 100-micron
thick later, and then, evaluating the wear. When doing this process, two big
differences were noted in the products. The extent of vertical wear of the Opal Seal
product after 9 months was very might greater than was that of the L.E.D. Pro Seal
product. In addition, this process allowed for an indication of potential loss of sealant
at the peripheral border of the protective resin film at the 9-month brushing time
period. Every specimen of Opal Seal demonstrated that a significant amount of
lateral enamel would have been exposed by sealant loss at the 9-month mark: up to
300 microns (0.3 mm) on each side of the placed film. However, when examining the
After 36 months of simulated tooth brushing, the differences in wearing between the
two products became even more evident. On every specimen of Opal Seal, a
significant portion of what would have been the initially protected enamel layer, had
lost sealant coverage, leaving the underlying enamel unprotected, and susceptible to
tooth brush abrasion or decalcification. In contrast, note the extremely lower loss of
sealant in the 36-month brushed specimens of L.E.D. Pro Seal compared to those of
Opal Seal. In every case, enamel surfaces covered by L.E.D. Pro Seal would have
totally protected all underlying enamel, or at least 95% of it. In addition, abundant
sealant remained above the enamel after this time period to provide, yet even longer
protection past the last measured time point.
In short, it can be seen that L.E.D. Pro Seal lasted for 3 years of extensive tooth
brushing with a very abrasive paste, whereas most enamel surfaces covered by
Opal Seal would have lost protection after only 9 months of brushing. The data
indicated that L.E.D. Pro Seal would have provided even longer protection to
enamel, if the testing process been continued.