3M(tm) ESPE(tm) Clinpro(tm) Sealant

Clinpro™ Sealant
Technical Product Profile
1
2
Table of Contents
Background .......................................................................................................... 5
Types Of Sealants ................................................................................................. 6
Product Description .............................................................................................. 7
Composition ......................................................................................................... 8
Physical Properties ............................................................................................... 9
Evaluations ......................................................................................................... 11
Technique Guide ................................................................................................. 12
Instructions For Use ........................................................................................... 13
Questions and Answers ...................................................................................... 16
Comparison of Sealant Features ......................................................................... 17
Kit Contents ........................................................................................................ 18
Summary ............................................................................................................ 18
References .......................................................................................................... 19
3
4
Background
Sealants are dental resins that are applied to the pits and fissures of teeth to inhibit dental
caries. The success of a sealant depends upon adhering firmly to the enamel surface, and
isolating pits and fissures from the rest of the oral environment. Pits and fissures are fossi
and grooves that failed to fuse during development. The narrow width and uneven depth
make them a haven for acid producing bacteria to accumulate. Saliva, which helps to clean
food particles from other areas of the mouth, cannot clean pits and fissures in molars. Even
a single toothbrush bristle is too large to enter and clean most fissures. The sealant acts as a
physical barrier preventing oral bacteria and dietary carbohydrates from creating the acid
conditions that result in caries. Placement of a conventional sealant is a non-invasive
technique that maintains tooth integrity while providing an acceptable resolution of the
carious process.
Trapping bacteria beneath the sealants is inevitable. Also, inadvertent sealing of initial
carious lesions can occur. Neither of these processes increase the chance of caries developing or caries growing beneath the surface. The ability of bacteria to survive under sealant is
considerably impaired because ingested carbohydrates cannot reach them. Several investigators have found that the number of bacteria in sealed carious lesions decreases dramatically with time. Radiographs of occlusal lesions that were deliberately sealed for investigational purposes failed to show lesion enlargement several years after being sealed. These
findings demonstrate not only that caries will not progress beneath a properly placed
sealant, but also that a lesion inadvertently sealed will arrest.1, 2
Twelve and a half percent of all the different tooth surfaces in the mouth are occlusal
surfaces. These surfaces develop more than two-thirds of the total caries experienced by
children. According to a report from the National Institutes of Health, pit and fissure caries
accounted for at least 88 percent of the total caries experienced by U.S. school children
between 1986 and 1987. With the use of pit and fissure sealants, however, occlusal surfaces
need not become carious.
The first clinical sealant trial was reported in 1965. Since then, many clinical and laboratory reports have documented sealant safety and effectiveness. The first provisional
acceptance of a marketed sealant by the ADA was granted in the early seventies.3
Sealants are primarily used on children, but adults with appropriate indications can also
benefit from their use. The dental professional must exercise proper patient selection and
application techniques. Occlusal sealants are useful in the maintenance of selected patients
through the caries-active period (ages 6 to 15 years), and will at least delay the need for an
occlusal restoration until a proximal lesion develops. Since sealants were first introduced
more than 25 years ago, new materials have been developed, and many aspects of sealant
application technique have been modified.
The majority of dental professionals have determined their stand on sealant use, their
philosophies of practice, and/or sealant technique. Most are faithful to their own viewpoints
and can quote studies that support their views. Regardless of their differing individual
viewpoints, scientific research on pit and fissure sealants has proven sealants are an
effective way to prevent caries development.
Sealant effectiveness is directly related to sealant retention since caries will not occur if the
sealant remains in place completely covering the pits and fissures. Often dental professionals are reluctant to place sealants because of the fear of loss or partial loss of sealant. The
consequences of sealant loss can be diminished with regular maintenance. In the longest
5
clinical study done on sealant retention, the following percentages were recorded over the
years with 3M™ ESPE™ Concise™ Sealant:
5 Years – 82%
10 Years – 57%
15 Years – 28%
Seventy-four percent of the sealed permanent first molars were non-carious after 15 years.4
Dr. Simonsen only studied a single application of sealant, if the sealants were maintained
and reapplied when necessary the children could have been caries-free. A single application
is not the recommended regimen for placement, reapplication every 6 months, if needed, is
recommended by the ADA.5
Types Of Sealants
Composition
There is a wide variety of sealant materials from which to choose. The components of
sealants are similar to those of composite resin restorative materials. Most sealants are
either bisphenol methacrylate resins or urethane-based products. Glass ionomers have been
suggested as sealant materials; however, clinical studies have found retention of glass
ionomers to be significantly poorer than that of resins.6,7
Recent safety concerns about Bis-DMA based sealants stemmed from a report that resin
based dental materials may be a source of exposure to xenoestrogens, compounds that
mimic estrogen and may affect reproductive tissues adversely.8 A recent study supported by
the American Dental Association reported that BPA released orally from a dental sealant
may not be absorbed systemically or the quantity absorbed if any is minute and below
detectable quantities.9
Color
Sealants may be clear, tinted, or opaque. Opaque or white sealants contain a small amount
of opaquing agent, such as titanium dioxide. Tinted or opaque sealants are more popular
because they are easier than clear sealants to re-evaluate for retention and are also easier to
see when applying.
Presence of Fillers
Sealants are available as filled or unfilled. The addition of filler particles to sealant appears
to have little effect on clinical results. Filled and unfilled sealants penetrate the fissures
equally well, 10 demonstrate no difference in microleakage,11 and have similar retention
rates.12,13 Some clinicians feel a filled sealant is better because of a lower wear rate,
however the principle behind sealants is to flow down into the pits and fissures to form a
barrier. Occlusal wear experienced within a fissure is insignificant and sealant placement
should be avoided on the cuspal slopes. The need for occlusal adjustment following sealant
placement was studied by Tilliss et al.,14 suggesting that the natural wear of unfilled
sealants is sufficient to establish appropriate occlusion, while use of a filled sealant
material requires checking the occlusion and possible adjustment of occlusal contacts.
6
Fluoride
Sealants may be fluoride releasing or non-fluoride releasing. Although fluoride is released
from the sealant after polymerization, the clinical significance of this release has yet to be
proven. It has been suggested that fluoride release from sealants may have its greatest
effect at the base of the sealed groove, helping remineralize incipient enamel caries and
providing a fluoride-rich layer that should be more caries resistant, should the sealant be
lost. Clinical data comparing these two types of sealant is sparse. In one study, fluoridereleasing sealant had a slightly higher retention rate after one year than the sealant without
fluoride.15
Method of Polymerization
Sealant materials are classified by method of polymerization. Both auto polymerizing
(chemical cure) and visible light-cure sealants are available. Numerous studies have
compared bond strengths and retention rates of the two and found that they offer comparable results.16
Product Description
3M™ ESPE™ Clinpro™ Sealant is a light-cure, low viscosity, fluoride releasing pit and
fissure sealant with a unique patented color change feature. Clinpro sealant is pink when
applied to the tooth surface, and changes to an opaque off white color when exposed to
light. The pink color helps the dental professional with the accuracy and amount of
material placed during the sealant procedure.
A sealant exhibiting any pink coloring is not completely cured. The color change from
pink to off white is not an absolute cure indicator. Therefore, sealant needs to be
cured with a dental curing light for the recommended exposure time.
Clinpro sealant contains a patented soluble organic fluoride source. The fluoride is released
from the sealant in a diffusion-limited process by exchange of hydroxide for the fluoride
ion. The composition remains homogenous for a prolonged period and allows cured sealant
to release fluoride.
Clinpro sealant is packaged in two forms: in 1.2 ml syringes with 27gauge Luer lock blunt
needle tips for direct delivery to the tooth, and in 6ml plastic bottles with a drop dispenser
tip.
A 35% phosphoric acid gel is included with the Intro Kits of 3M ESPE Clinpro Sealant.
Many clinicians prefer to use a gel because it is easily applied and controlled and because
of its color, which makes it easy to see where it has been applied. Enamel is composed of
hydroxyapatite crystals arranged in hexagonal prisms forming rods oriented at right angles
to the surface. The enamel surface is usually in a low energy weakly reactive, hydrophobic
state. However, when exposed to the acid it becomes a high-energy, strongly reactive,
hydrophilic surface. This high-energy state provides for the rapid attraction of the sealant
to the enamel surface.17
7
Composition
Listed below are the components of the 3M™ ESPE™ Clinpro™ Sealant and their functions.
Component
Common Name
Function
Bisphenol A Diglycidyl
methacrylate
Bis-GMA
Matrix resin monomer
Triethylene glycol
dimethacrylate
TEGDMA
Matrix resin monomer
EDMAB
Component of the photo-initiator system
Diphenyliodonium
hexafluorophosphate
I+
Component of the photo-initiator system
DL-Camphorquinone
CPQ
Component of the photo-initiator system
Butylated hydroxytoulene
BHT
Stabilizer, radical scavenger
Dichorodimethylsilane
reaction product
with silica
Silane treated
amorphous silica
Reinforced inorganic filler with a
particle size of .016 micrometers
Tetrabutylammonium
tetrafluoroborate
TBATFB
Fluoride releasing source
TiO2
Provides white color
C. I. 45440
Adds color before curing
Ethyl 4(dimethylamino)benzoate
Titanium Dioxide
Rose bengal sodium
8
Physical Properties
3M™ ESPE™ Clinpro™ Sealant meets ISO 6874 Dental resin based pit and fissure sealant,
Type II specifications for:
•
Appearance
•
Sensitivity to Ambient Light
•
Curing Time
•
Depth of Cure
•
Uncured Film Thickness
It also meets ANSI/ADA Spec 39 for pit and fissure sealant, Type 2.
Adhesion
Adhesion is evaluated in the 3M ESPE Laboratory by potting bovine or human teeth in
methacrylate resin, then grinding and polishing these to expose enamel. The enamel
surfaces are then treated in accordance with manufacturers’ instructions for bonding. A
Teflon mold 5mm in diameter and 2mm in height is placed over the treated surface. The
test material is placed in the mold to form a button and cured according to manufacturers’
instructions. They are then placed into water at 37°C before shear bond strength is determined. Bond strength is tested on an Instron universal testing machine at a crosshead speed
of 2mm/minute.
Shown as Figure 1, the shear bond strength to enamel of Clinpro sealant was compared
to several competitive sealant products. All sealants were tested using the manufacturers’
recommended techniques. All shear bond strengths were determined from a sample size of
10 for each product. A bar next to adhesion values depicts no statistical difference among
members of that group.
Delton DDS
Figure 1.
Adhesion to Enamel
Ultraseal XT Plus
Clinpro
Delton Plus
Helioseal F
0
2 4
6 8 10 12 14 16 18
MPa
9
Fluoride Release
In the 3M ESPE Laboratory, fluoride release was tested by measuring fluoride released into
de-ionized water, a method used commonly among researchers around the world. Test
specimens are made in 20-mm diameter by 1mm thick molds and cured. Each specimen is
then placed into a vial containing 25 ml of de-ionized water and stored in a 37°C oven. At
the time of fluoride measurement, an aliquot of the water containing the test specimen is
taken, diluted 1:1 with TISAB (Total Ionic Strength Adjustment Buffer – Orion Research),
and parts per million of fluoride are measured directly using a fluoride ion-specific electrode. The de-ionized water that remains in the specimen jar is discarded, 25 ml of fresh deionized water is added, and the test specimen is returned to the jar, which is again stored in
a 37°C oven. The process is repeated for each time interval of testing. The fluoride released
by the test specimen is reported as cumulative micrograms of fluoride per weight of
specimen or can be reported per area of specimen. The advantage of this test method is that
the test specimen is exposed to fresh solution at greater frequency, which may allow more
accurate release of fluoride and may better represent the clinical situation.
Shown, as Figure 2 is the cumulative fluoride released from 3M™ ESPE™ Clinpro™ Sealant
in comparison with other competitive sealant products, namely Ultraseal® XT Plus™,
Helioseal F®, and Delton Plus®.
Figure 2.
Cumulative
Fluoride Release
Micrograms fluoride/gram sample
900
H
800
H
700
H
600
500
H
H
H
400
300
H
H
200
100 H
F
F
J
F
J B
JB
JB
F
JB
F
B
J
B
F
0H
J
0
F
J
B
F
J
B
B
Ultraseal
H
Delton Plus
J
Helioseal F
F
Clinpro Sealant
F
F
J
B
J
B
100
200
Days
10
H
300
Evaluations
Numerous in-vitro evaluations were done on prototypes of 3M™ ESPE™ Clinpro™ Sealant
and dispensing systems with assistants, hygienists, dentists, and members of the AAPD
(American Academy of Pediatric Dentists), and the ADHA (American Dental Hygienists
Association). From the results of these initial evaluations a prototype of the final product
was developed and evaluated in-vivo with practicing dentists, hygienists, and assistants in
the United States and throughout the world. The respondents within the U.S were equally
divided between the three professions and used a variety of sealant products.
Eighty-three percent of the evaluators found the placement of Clinpro sealant easier
because of the color change feature.
A section of the evaluation asked for a rating from 1 to 5 (5 = excellent and 1 = poor) of
six different characteristics. A majority of the evaluators awarded 4 and 5’s for the Clinpro
sealant on all six features shown in Figure 3.
Figure 3.
Percentage of 4 and 5
ratings for 3M™ ESPE™
Clinpro™ Sealant
Placement Accuracy
92
Color Change
92
Overall Handling
89
Flow of Sealant
85
Syringe Dispenser
85
Etchant Performance
88
0
20
40
60
%
80
100
A high percentage (88%) said they experienced the same or fewer bubbles with
Clinpro sealant compared to their current product.
Figure 4.
Bubbles with Clinpro
sealant compared to
current sealant product
Less
Same
More
0
10
20
30
40
50
%
Over three-quarters (77%) rated the overall performance of Clinpro sealant to be better
than their current sealant product.
Figure 5.
Clinpro sealant
performance compared
to current
5=better
}
4
77%
3
2
1=poor
0
10
20
30
40
50
%
11
Technique Guide
FISSURES
Indications:
• 3M™ ESPE™ Clinpro™ Sealant is designed for sealing the enamel pits and fissures of teeth
to aid in the prevention of caries.
Preparation:
• Select teeth. Teeth must be sufficiently erupted so that a dry field can be maintained.
• Clean Enamel. Thoroughly clean teeth to remove plaque and debris from enamel surfaces
and fissures. Rinse thoroughly with water. Note: Do not use any cleaning medium that may
contain oils.
• Isolate teeth and dry. While a rubber dam provides the best isolation, cotton rolls used in
conjunction with isolation shields, are acceptable.
Etch Enamel:
• Using syringe tip, or fiber tip, apply a generous amount of
etchant to all enamel surfaces to be sealed, extending beyond
the anticipated margin of the sealant.
• Etch for a minimum of 15 seconds, but no longer than 60
seconds.
Rinse Etched Enamel:
• Thoroughly rinse teeth with air/water spray to remove etchant.
• Do not allow patient to swallow or rinse. If saliva contacts the
etched surfaces, re-etch for 5 seconds and rinse.
Dry Etched Enamel:
• Thoroughly dry the etched surfaces.
• Air should be oil and water free.
• The dry etched surfaces should appear as a matte frosty white.
If not, repeat steps 1 and 2. Do not allow the etched surface
to be contaminated.
Apply Sealant:
• Using the syringe needle tip or a brush, apply sealant into the
pits and fissures. Do not let sealant flow beyond the etched
surfaces.
• Stirring the sealant with the syringe-tip during or after
placement will help eliminate any possible bubbles, and
enhance the flow into the pit and fissures. An explorer may
also be used.
Light-Cure:
• Cure the sealant by exposing it to light from a 3M™ ESPE™
Curing Light, or other curing unit of comparable intensity.
• A 20-second exposure is needed for each surface. The tip of the
light should be held as close as possible to the sealant, without
actually touching the sealant. When set, the sealant forms a
hard, opaque film, light yellow in color with a slight surface
inhibition.
Wipe Clean:
• Wipe the sealant with a cotton applicator to remove the thin
film on the surface.
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Instructions For Use
Description
3M™ ESPE™ Clinpro™ Sealant is a light-cure, low viscosity, fluoride releasing pit and
fissure sealant with a unique patented color change feature. Clinpro sealant is pink when
applied to the tooth surface, and changes to an opaque off white color when exposed to
light. The pink color helps the dental professional with the accuracy and amount of
material placed during the sealant procedure.
A sealant exhibiting any pink coloring is not completely cured. The color change from
pink to off white is not an absolute cure indicator. Therefore, sealant needs to be
cured with a dental curing light for the recommended exposure time.
Technical Information
•
Meets ISO 6875 (Dental resin based pit and fissure sealant)
•
Meets ANSI/ADA Spec 39 (Pit and fissure sealant)
•
BIS-GMA/TEGDMA resin composition
•
Unfilled
•
Curing light must have minimum output of 400 mW/cm2
•
Use at room temperature
Storage and Use
•
Replace caps on syringes and bottles immediately after use.
•
Do not expose materials to elevated temperatures.
•
Do not store materials in proximity to eugenol-containing products.
•
The etchant and sealant are designed to be used at room temperatures of
approximately 21º-24ºC or 70º-75ºF
•
Shelf life at room temperature is 24 months.
Indications
Clinpro sealant is designed for sealing the enamel pits and fissures of teeth to aid in the
prevention of carries.
Precautions For Dental Personnel And Patients
•
Etchant Precautions: 3M™ ESPE™ Scotchbond™ Etching Gel contains 35% by
weight phosphoric acid. Protective eyewear for patients and dental staff is recommended when using etchants. Avoid contact with oral soft tissue, eyes, and skin. If
accidental contact occurs, flush immediately with large amounts of water. For eye
contact, immediately rinse with plenty of water and seek medical attention
•
Sealant Precautions: 3M™ ESPE™ Clinpro™ Sealant contains acrylate resins.
Avoid use of this product on patients with known acrylate allergies. To reduce the
risk of allergic response, minimize exposure to these materials. In particular, avoid
exposure to uncured resin. Use of protective gloves and a no-touch technique is
13
recommended. If skin contact occurs, wash skin with soap and water. Acrylates
may penetrate commonly used gloves. If sealant contacts glove, remove and
discard glove, wash hands immediately with soap and water then re-glove. If
accidental contact with eyes or prolonged contact with oral soft tissue occurs,
flush with large amounts of water. If irritation persists, consult a physician.
Dispensing Sealant
Follow the directions corresponding to the dispensing system chosen. Sealant is light
sensitive. Exposure to overhead operatory lights will initiate the color change and curing.
Syringe
1.
Protective eyewear is recommended for patients and staff when using a syringe
type dispenser.
2.
Prepare delivery system: Remove cap from syringe and SAVE. Twist a disposable
tip securely onto the syringe. Holding the tip away from the patient and any dental
staff express a small amount of material onto a mix pad or 2×2 gauze to assure the
delivery system is not clogged. If clogged, remove the tip and express a small
amount of material form the syringe. Remove any visible plug, if present, from the
syringe opening. Replace syringe tip and again check flow form tip. If clog
remains, discard dispensing tip and replace with a new one.
3.
At the completion of the procedure remove used syringe-tip and discard. Twist on
storage cap. Storage of the syringe with a used dispensing tip, or without the
storage cap will allow drying or curing of the product and consequent clogging of
the system. Replace storage cap with a new dispensing tip at next use.
4.
Disinfection: Discard used syringe tip and replace with syringe storage cap.
Disinfect the capped syringe in the same manner as recommended by the ADA
and CDC for non-immersible dental items. Council on Dental Materials, Instruments, and Equipment and Council on Dental Therapeutics, Infection control
recommendations for the dental office and dental laboratory. JADA 116(2):241248, 1988).
Bottle
1.
Dispense 1 to 2 drops of sealant into the mix well. Immediately slide cover over
well to protect from light.
2.
Re-cap sealant bottle.
3.
After removing material from well always replace cover slide.
4.
Disinfection: Disinfect the bottle following procedures for non-immersible dental
items as stated under “Syringe #4”.
Disinfect mix well and applicator handles following disinfecting solution
manufacturer’s recommendations.
Application Guide
The acid etch technique requires care, particularly for isolation and prevention of contamination. The enamel to be bonded must be cleaned, and thoroughly washed and dried, and
maintained free from contamination prior to sealant placement.
14
Technique
1.
Check air/water syringe. Blow a jet of air from syringe onto a glove or mirror. If
small droplets are seen the syringe must be adjusted so only air is expressed. Any
moisture contamination during certain stages of this procedure will compromise
the integrity of a sealant.
2.
Select Teeth. Teeth must be sufficiently erupted so that a dry field can be maintained. The morphology of the pits and fissures should be deep.
3.
Clean Enamel. Thoroughly clean teeth to remove plaque and debris from enamel
surfaces and fissures. Rinse thoroughly with water.
Note: Do not use any cleaning medium that may contain oils. If using an airpolish device that utilizes sodium bicarbonate for cleaning, the etching step
should be repeated a second time, or 3% hydrogen peroxide should be applied
to the surface for 10 seconds to neutralize the sodium bicarbonate, and then
thoroughly rinsed with water prior to applying etch.
4.
Isolate Teeth and Dry. While a rubber dam provides the best isolation, cotton
rolls used in conjunction with isolation shields are acceptable. Use saliva ejection
device or high volume evacuation if possible.
5.
Etch Enamel. Apply a generous amount of etchant to all enamel surfaces to be
sealed, extending beyond the anticipated margin of the sealant. Etch for a minimum of 15 seconds, but no longer than 60 seconds.
6.
Rinse Etched Enamel. Thoroughly rinse teeth with air/water spray to remove
etchant. Remove rinse water with suction. Do not allow patient to swallow or
rinse. If saliva contacts the etched surfaces, re-etch for 5 seconds and rinse.
7.
Dry Etched Enamel. Thoroughly dry the etched surfaces. Air should be oil and
water free. The dry etched surfaces should appear as a matte frosty white. If not,
repeat steps 5 and 6.
DO NOT ALLOW THE ETCHED SURFACE TO BE CONTAMINATED.
Clinical studies have clearly shown that moisture contamination of these surfaces
is the main cause for failure of pit and fissure sealants. Immediately apply sealant.
8.
Apply Sealant. Using the syringe needle tip or a brush, slowly introduce sealant
into the pits and fissures. Do not let sealant flow beyond the etched surfaces.
Stirring the sealant with the syringe tip during or after placement will help
eliminate any possible bubbles, and enhance the flow into the pit and fissures. An
explorer may also be used.
Cure the sealant by exposing it to light from a 3M™ ESPE™ Curing Light, or other
curing unit of comparable intensity. A 20-second exposure is needed for each
surface, The tip of the light should be held as closely as possible to the sealant,
without actually touching the sealant. When set, the sealant forms a hard, opaque
film light yellow in color with a slight surface inhibition.
9.
Evaluate Sealant. Inspect sealant for complete coverage and voids. If surface has
not been contaminated, additional sealant may be added. If contamination has
occurred re-etch, rinse, and dry prior to placing more sealant.
10. Dismissal. Wipe the sealant with a cotton applicator to remove the thin sticky
film on the surface. Check occlusion and adjust as required.
15
Questions And Answers
Can I use a bonding agent with 3M™ ESPE™ Clinpro™ Sealant?
Clinpro sealant is not recommended for use with a bonding agent. However, several studies
have been conducted with sealants and bonding agents. This technique has been shown to
be useful when applying sealant to teeth that are difficult to keep isolated and there is
concern about moisture contamination.18,19
If using a high power curing light, how many seconds are needed to cure
Clinpro sealant?
3M ESPE lab testing showed Clinpro sealant required the following cure times to pass the
desired Barcol hardness test rating of 30, or higher, on both the top and bottom of prepared
samples:
•
Apollo™ 95E, a plasma arc curing system by DMD, required a 3-second cure time.
•
AccuCure 3000™ a laser curing system by Lasermed required a 10 second cure.
How many teeth can be sealed with one syringe of Clinpro sealant?
Approximately 70 applications. However, there are several variables that can impact this
answer.
Can I use a fluoride prophy paste to clean the teeth before placing a sealant?
No deleterious-effects have been identified when polishing with either fluoridated or nonfluoridated polishing pastes.20
A study on estrogenicity of resin based dental composites and sealants has raised
controversy and concern about the safety of monomers (Bisphenol-A generated
from Bis-DMA) leached out of these materials. Bisphenol-A has the potential to
emulate the hormone estrogen.8 Is Clinpro sealant in this category?
Several 3M ESPE products contain BIS-GMA, which is a different molecule from BisDMA.
After curing, why is there such a heavy air-inhibited layer on the sealant?
The air-inhibited layer is unavoidable with sealant chemistry. Thinner layers will produce a
higher level of air inhibition. The ADA requires an uncured film thickness of not more than
0.1µm. Clinpro sealant has an uncured film thickness of .04µm.
Because you are etching the enamel beyond where the sealant will be placed, will
this exposed etched enamel now be more susceptible to caries?
The caries process on the occlusal surface is initiated within the fissures not on the cuspal
inclines. In addition it has been shown that etched enamel remineralizes completely within
48 hours because of the disposition of salivary calcium and phosphate salts.17
Are sealants covered by insurance?
The majority of dental insurance companies have coverage for sealants. However, they
do not always reimburse the dental professional if a sealant needs to be replaced.
16
What is a preventive resin restoration?
The preventive resin restoration is the conservative answer to conventional “extension for
prevention” philosophy of Class I amalgam cavity preparation. Extension for prevention
dictates that the outline form of the cavity preparation be extended beyond the margins of
the cavity to incorporate all susceptible pits and fissures. Using composite resin restoratives, bonding agents, and unfilled resin materials instead of amalgam does provide for a
more conservative preparation. This extension prevents future caries formation, but does so
at the expense of losing some healthy tooth structure. The technique and composite
materials used for this procedure can have several variations.
Comparison of Sealant Features
Brand
% Fill Fluoride
Shelf Life
Application
Color
Other
Clinpro™ Sealant
3M™ ESPE™
6
Y
24 mo.
Syringe-1.2ml
Bottle-6ml
White
Changes
color
UltraSeal XT®Plus™
Ultradent®
60
Y
24 mo.
refrigerate
Syringe-1.2ml
White
Translucent
A2
Additional
ingredient/step
Prima Dry
Radiopaque
Helioseal® F
Ivoclar-Vivadent
43
Y
36 mo.
Unit dose-.08ml ea.
Syringe-2.5gm
Bottle-8ml
White
Must wait
15 seconds
before cure
Delton® FS+
Dentsply/Chalk
55
Y
18 mo.
Unit dose-.08ml ea.
Syringe-1.9g
White
Clear
Radiopaque
Delton® DDS
Dentsply/Chalk
*
N
24 mo.
Unit dose-.08ml ea.
White
Clear
*
Seal-Rite™
Pulpdent
8
Y
18 mo.
Syringe-1.2ml
White
Also available
high viscosity
34% filled
17
Kit Contents
3M™ ESPE™ Clinpro™ Sealant
Clinpro Sealant
Introduction Kit
Syringes
Clinpro Sealant
Refill
Syringe
Clinpro Sealant
Introduction Kit
Bottles
Clinpro Sealant
Refill
Bottle
2 - 1.2 ml
sealant syringe
1 - 1.2 ml
sealant syringe
2 - 6ml
sealant bottles
1 - 6ml
sealant bottle
1 - 3ml syringe
35% acid etch gel
1bag - 10 count
black sealant
syringe tips
1 - 9ml bottle
35% acid etch gel
1 - instructions
2 bags - 10 count
black sealant
syringe tips
1 - instructions
1 bag - 60 count
sealant brush tips
1 bag - 25 count
blue etchant syringe tips
2 bag - 50 count
etchant fiber tips
1 – instructions
2 - brush handles
1 black covered mixwell
1 – instructions
Summary
The following is a summary of the features of 3M™ ESPE™ Clinpro™ Sealant:
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Sealant is pink, then changes to white when cured
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Color change makes it easy to control and visualize placement.
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Releases fluoride.
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Contains a patented organic fluoride.
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Off white opaque color for ease of re-evaluation.
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Easy to use syringe dispenser.
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Ultra-fine syringe tip for controlled dispensing.
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Fewer bubbles seen.
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Fewer occlusal adjustments than a filled sealant.12
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Familiar conventional sealant technique.
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Available in both syringe and bottle.
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Easy to understand instructions.
Warranty
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3M ESPE will replace products that are proved to be defective. 3M ESPE does not accept
liability for any loss or damage direct or consequential arising out of the use of or the
inability to use the products. Before using, the user shall determine the suitability of the
product for its intended use and user assumes all risk and liability whatsoever in connection
with use of this product.
References
1.
Going RE, Loesche WJ Grainger Da, Sted SA: The viability of micro organisms in
carious lesions five years after covering with a fissure sealant. JADA 1979,
97;455-462.
2.
Mertz-Fairhurst EJ, Schuster GS, Fairjurst CW: Arresting caries by sealants:
Results of a clinical study. JADA 1986,112;194-197.
3.
ADA Council on Dental Materials and Devices and the Council on Dental Therapeutics: Pit and fissure sealants. J Am Dent Assoc 93:134, 1976.
4.
Simonsen R: Retention and effectiveness of dental sealant after 15 years. JADA
1991;122:34-43.
5.
American Dental Association, Council on Dental Materials, Instruments, and
Equipment. Pit and Fissure Sealants. J Am Dent Assoc 114:671, 1987.
6.
Mejare I. Mjor IA: Glass ionomer and resin-based fissure sealants: A clinical
study. Scand J Dent Res 1990; 345-350.
7.
Torppa-Saarinen E, Seppa L:Short-term retention of glass-ionomer fissure sealants. Proc Finn Dent Soc 1990; 86:83-88.
8.
Olea N, Pulgar R, Perez P, et al.: Estrogenicity of resin-based composites and
sealants used in dentistry. Environ Health Persp 1996; 104:298-305.
9.
Fung, EY., et al. Pharmacokinetics of bisphenol A released from a dental sealant.
JADA 2000 131(1):51-58.
10. Feldens EG, Feldens CA, de Araujo FB, et al. Invasive technique of pit and fissure
sealants in primary molars: an SEM study. J Clin Pediatr Dent 1994; 18(3):187190.
11. Park K, Georgescu M, Scherer W, Schulman A. Comparison of shear strength,
fracture patterns and microleakage among unfilled, filled and fluoride-releasing
sealant. Pediatr Dent 1993; 15:418-20.
12. Boksman L, McConnell RJ, Carson B, et al. A 2-year clinical evaluation of two pit
and fissure sealants placed with and without the use of a bonding agent. Quintessence Int 1993; 24(2):131-3.
13. Barrie AM, Stephen KW, Kay EJ. Fissure sealant retention: a comparison of three
sealant types under field conditions. Community Dent Health. 1990; 7:273-7.
14. Tilliss TS, Stach DJ. Hatch RA, et al.: Occlusal discrepancies after sealant therapy.
J Pros Dent 1992; 68:223-228.
15. Jensen OE, Billings RJ, Carson B, et al. Clinical evaluation of Fluroshield pit and
fissure sealant. Clin Prevent Dent 1990; 12(4):24-27.
16. Shapira J., et al. A comparative clinical study of auto polymerized fissure sealants:
Five-year results. Pediatr Dent 12:168, 1990.
17. Mathewson RJ, Primosch RE. Fundamentals of Pediatric Dentistry. Third Edition.
chapter 8: 119-134.
18. Feigal RJ, Hitt J, Splieth C. Retaining sealant on salivary contaminated enamel.
JADA 124:88-96, 1993.
19. Hitt JC, Feigal RJ. Use of bonding agent to reduce sealant sensitivity to moisture
contamination: An in-vitro study. Pediatr Dent 14:41-46, 1992.
20. Pope BDJ, Garcia-Godoy F, Summitt JB, Chan DD. Effectiveness of occlusal
fissure cleansing methods and sealant micromorpholgy. ASDC J Cent Child 1996;
63; 175-180.
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3M, Clinpro, Concise, and Scotchbond are trademarks of 3M Company.
ESPE is a trademark of 3M ESPE AG.
Accucure is a trademark of Lasermed.
Apollo is a trademark of DMD.
Delton‚ is a registered trademark of Dentsply International.
Helioseal‚ F is a registered trademark of Vivadent Ets.
SealRite is a trademark of Pulpdent.
Ultraseal XT Plus is a registered trademark of Ultradent.
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Dental Products
3M Center, Building 275-2SE-03 3M Canada
St. Paul, MN 55144-1000
Post Office Box 5757
U.S.A.
London, Ontario, Canada N6A4T1
1-800-634-2249
40% Pre-consumer waste paper
10% Post-consumer waste paper
Printed in U.S.A.
© 3M IPC 2001 70-2009-2265-9