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Clinpro™ Sealant Technical Product Profile

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Table of ContentsBackground .......................................................................................................... 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

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BackgroundSealants are dental resins that are applied to the pits and fissures of teeth to inhibit dentalcaries. The success of a sealant depends upon adhering firmly to the enamel surface, andisolating pits and fissures from the rest of the oral environment. Pits and fissures are fossiand grooves that failed to fuse during development. The narrow width and uneven depthmake them a haven for acid producing bacteria to accumulate. Saliva, which helps to cleanfood particles from other areas of the mouth, cannot clean pits and fissures in molars. Evena single toothbrush bristle is too large to enter and clean most fissures. The sealant acts as aphysical barrier preventing oral bacteria and dietary carbohydrates from creating the acidconditions that result in caries. Placement of a conventional sealant is a non-invasivetechnique that maintains tooth integrity while providing an acceptable resolution of thecarious process.

Trapping bacteria beneath the sealants is inevitable. Also, inadvertent sealing of initialcarious lesions can occur. Neither of these processes increase the chance of caries develop-ing or caries growing beneath the surface. The ability of bacteria to survive under sealant isconsiderably impaired because ingested carbohydrates cannot reach them. Several investi-gators have found that the number of bacteria in sealed carious lesions decreases dramati-cally with time. Radiographs of occlusal lesions that were deliberately sealed for investiga-tional purposes failed to show lesion enlargement several years after being sealed. Thesefindings demonstrate not only that caries will not progress beneath a properly placedsealant, 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 occlusalsurfaces. These surfaces develop more than two-thirds of the total caries experienced bychildren. According to a report from the National Institutes of Health, pit and fissure cariesaccounted for at least 88 percent of the total caries experienced by U.S. school childrenbetween 1986 and 1987. With the use of pit and fissure sealants, however, occlusal surfacesneed not become carious.

The first clinical sealant trial was reported in 1965. Since then, many clinical and labora-tory reports have documented sealant safety and effectiveness. The first provisionalacceptance 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 alsobenefit from their use. The dental professional must exercise proper patient selection andapplication techniques. Occlusal sealants are useful in the maintenance of selected patientsthrough the caries-active period (ages 6 to 15 years), and will at least delay the need for anocclusal restoration until a proximal lesion develops. Since sealants were first introducedmore than 25 years ago, new materials have been developed, and many aspects of sealantapplication technique have been modified.

The majority of dental professionals have determined their stand on sealant use, theirphilosophies of practice, and/or sealant technique. Most are faithful to their own viewpointsand can quote studies that support their views. Regardless of their differing individualviewpoints, scientific research on pit and fissure sealants has proven sealants are aneffective way to prevent caries development.

Sealant effectiveness is directly related to sealant retention since caries will not occur if thesealant remains in place completely covering the pits and fissures. Often dental profession-als are reluctant to place sealants because of the fear of loss or partial loss of sealant. Theconsequences of sealant loss can be diminished with regular maintenance. In the longest

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clinical study done on sealant retention, the following percentages were recorded over theyears 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 maintainedand reapplied when necessary the children could have been caries-free. A single applicationis not the recommended regimen for placement, reapplication every 6 months, if needed, isrecommended by the ADA.5

Types Of Sealants

Composition

There is a wide variety of sealant materials from which to choose. The components ofsealants are similar to those of composite resin restorative materials. Most sealants areeither bisphenol methacrylate resins or urethane-based products. Glass ionomers have beensuggested as sealant materials; however, clinical studies have found retention of glassionomers to be significantly poorer than that of resins.6,7

Recent safety concerns about Bis-DMA based sealants stemmed from a report that resinbased dental materials may be a source of exposure to xenoestrogens, compounds thatmimic estrogen and may affect reproductive tissues adversely.8 A recent study supported bythe American Dental Association reported that BPA released orally from a dental sealantmay not be absorbed systemically or the quantity absorbed if any is minute and belowdetectable quantities.9

Color

Sealants may be clear, tinted, or opaque. Opaque or white sealants contain a small amountof opaquing agent, such as titanium dioxide. Tinted or opaque sealants are more popularbecause they are easier than clear sealants to re-evaluate for retention and are also easier tosee when applying.

Presence of Fillers

Sealants are available as filled or unfilled. The addition of filler particles to sealant appearsto have little effect on clinical results. Filled and unfilled sealants penetrate the fissuresequally well, 10 demonstrate no difference in microleakage,11 and have similar retentionrates.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 abarrier. Occlusal wear experienced within a fissure is insignificant and sealant placementshould be avoided on the cuspal slopes. The need for occlusal adjustment following sealantplacement was studied by Tilliss et al.,14 suggesting that the natural wear of unfilledsealants is sufficient to establish appropriate occlusion, while use of a filled sealantmaterial requires checking the occlusion and possible adjustment of occlusal contacts.

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Fluoride

Sealants may be fluoride releasing or non-fluoride releasing. Although fluoride is releasedfrom the sealant after polymerization, the clinical significance of this release has yet to beproven. It has been suggested that fluoride release from sealants may have its greatesteffect at the base of the sealed groove, helping remineralize incipient enamel caries andproviding a fluoride-rich layer that should be more caries resistant, should the sealant belost. Clinical data comparing these two types of sealant is sparse. In one study, fluoride-releasing sealant had a slightly higher retention rate after one year than the sealant withoutfluoride.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 havecompared bond strengths and retention rates of the two and found that they offer compa-rable results.16

Product Description3M™ ESPE™ Clinpro™ Sealant is a light-cure, low viscosity, fluoride releasing pit andfissure sealant with a unique patented color change feature. Clinpro sealant is pink whenapplied to the tooth surface, and changes to an opaque off white color when exposed tolight. The pink color helps the dental professional with the accuracy and amount ofmaterial placed during the sealant procedure.

A sealant exhibiting any pink coloring is not completely cured. The color change frompink to off white is not an absolute cure indicator. Therefore, sealant needs to becured with a dental curing light for the recommended exposure time.

Clinpro sealant contains a patented soluble organic fluoride source. The fluoride is releasedfrom the sealant in a diffusion-limited process by exchange of hydroxide for the fluorideion. The composition remains homogenous for a prolonged period and allows cured sealantto release fluoride.

Clinpro sealant is packaged in two forms: in 1.2 ml syringes with 27gauge Luer lock bluntneedle tips for direct delivery to the tooth, and in 6ml plastic bottles with a drop dispensertip.

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 becauseof its color, which makes it easy to see where it has been applied. Enamel is composed ofhydroxyapatite crystals arranged in hexagonal prisms forming rods oriented at right anglesto the surface. The enamel surface is usually in a low energy weakly reactive, hydrophobicstate. 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 sealantto the enamel surface.17

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CompositionListed below are the components of the 3M™ ESPE™ Clinpro™ Sealant and their functions.

Component Common Name Function

Bisphenol A Diglycidyl Bis-GMA Matrix resin monomermethacrylate

Triethylene glycol TEGDMA Matrix resin monomerdimethacrylate

Ethyl 4- EDMAB Component of the photo-initiator system(dimethylamino)benzoate

Diphenyliodonium I+ Component of the photo-initiator systemhexafluorophosphate

DL-Camphorquinone CPQ Component of the photo-initiator system

Butylated hydroxytoulene BHT Stabilizer, radical scavenger

Dichorodimethylsilane Silane treated Reinforced inorganic filler with areaction product amorphous silica particle size of .016 micrometerswith silica

Tetrabutylammonium TBATFB Fluoride releasing sourcetetrafluoroborate

Titanium Dioxide TiO2 Provides white color

Rose bengal sodium C. I. 45440 Adds color before curing

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Physical Properties3M™ 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 inmethacrylate resin, then grinding and polishing these to expose enamel. The enamelsurfaces are then treated in accordance with manufacturers’ instructions for bonding. ATeflon mold 5mm in diameter and 2mm in height is placed over the treated surface. Thetest 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 deter-mined. Bond strength is tested on an Instron universal testing machine at a crosshead speedof 2mm/minute.

Shown as Figure 1, the shear bond strength to enamel of Clinpro sealant was comparedto several competitive sealant products. All sealants were tested using the manufacturers’recommended techniques. All shear bond strengths were determined from a sample size of10 for each product. A bar next to adhesion values depicts no statistical difference amongmembers of that group.

Helioseal F

Delton Plus

Clinpro

Ultraseal XT Plus

Delton DDS

0 2 4 6 8 10 12 14 16 18MPa

Figure 1.Adhesion to Enamel

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Fluoride Release

In the 3M ESPE Laboratory, fluoride release was tested by measuring fluoride released intode-ionized water, a method used commonly among researchers around the world. Testspecimens are made in 20-mm diameter by 1mm thick molds and cured. Each specimen isthen placed into a vial containing 25 ml of de-ionized water and stored in a 37°C oven. Atthe time of fluoride measurement, an aliquot of the water containing the test specimen istaken, 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 elec-trode. The de-ionized water that remains in the specimen jar is discarded, 25 ml of fresh de-ionized water is added, and the test specimen is returned to the jar, which is again stored ina 37°C oven. The process is repeated for each time interval of testing. The fluoride releasedby the test specimen is reported as cumulative micrograms of fluoride per weight ofspecimen or can be reported per area of specimen. The advantage of this test method is thatthe test specimen is exposed to fresh solution at greater frequency, which may allow moreaccurate release of fluoride and may better represent the clinical situation.

Shown, as Figure 2 is the cumulative fluoride released from 3M™ ESPE™ Clinpro™ Sealantin comparison with other competitive sealant products, namely Ultraseal® XT Plus™,Helioseal F®, and Delton Plus®.

Figure 2.CumulativeFluoride Release

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BB

B B

JJJJJJ

J J JJ J

H

H

H

H

HH

H

H

H

H H

FFFFFF

FF

F

F F

0

100

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0 100 200 300

Mic

rogr

ams

fluor

ide/

gram

sam

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J Helioseal F

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F Clinpro Sealant

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EvaluationsNumerous in-vitro evaluations were done on prototypes of 3M™ ESPE™ Clinpro™ Sealantand dispensing systems with assistants, hygienists, dentists, and members of the AAPD(American Academy of Pediatric Dentists), and the ADHA (American Dental HygienistsAssociation). From the results of these initial evaluations a prototype of the final productwas developed and evaluated in-vivo with practicing dentists, hygienists, and assistants inthe United States and throughout the world. The respondents within the U.S were equallydivided between the three professions and used a variety of sealant products.

Eighty-three percent of the evaluators found the placement of Clinpro sealant easierbecause of the color change feature.

A section of the evaluation asked for a rating from 1 to 5 (5 = excellent and 1 = poor) ofsix different characteristics. A majority of the evaluators awarded 4 and 5’s for the Clinprosealant on all six features shown in Figure 3.

A high percentage (88%) said they experienced the same or fewer bubbles withClinpro sealant compared to their current product.

Over three-quarters (77%) rated the overall performance of Clinpro sealant to be betterthan their current sealant product.

Figure 3.Percentage of 4 and 5ratings for 3M™ ESPE™

Clinpro™ Sealant

Figure 4.Bubbles with Clinprosealant compared tocurrent sealant product

Figure 5.Clinpro sealantperformance comparedto current

Etchant Performance

Syringe Dispenser

Flow of Sealant

Overall Handling

Color Change

Placement Accuracy

0 20 40 60 80 100%

92

92

89

85

85

88

More

Same

Less

0 10 20 30 40 50%

1=poor

2

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4

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0 10 20 30 40 50%

77%}

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Technique Guide FISSURESIndications:

• 3M™ ESPE™ Clinpro™ Sealant is designed for sealing the enamel pits and fissures of teethto 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 surfacesand fissures. Rinse thoroughly with water. Note: Do not use any cleaning medium that maycontain oils.

• Isolate teeth and dry. While a rubber dam provides the best isolation, cotton rolls used inconjunction with isolation shields, are acceptable.

Etch Enamel:

• Using syringe tip, or fiber tip, apply a generous amount ofetchant to all enamel surfaces to be sealed, extending beyondthe anticipated margin of the sealant.

• Etch for a minimum of 15 seconds, but no longer than 60seconds.

Rinse Etched Enamel:

• Thoroughly rinse teeth with air/water spray to remove etchant.

• Do not allow patient to swallow or rinse. If saliva contacts theetched 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 surfaceto be contaminated.

Apply Sealant:

• Using the syringe needle tip or a brush, apply sealant into thepits and fissures. Do not let sealant flow beyond the etchedsurfaces.

• Stirring the sealant with the syringe-tip during or afterplacement will help eliminate any possible bubbles, andenhance the flow into the pit and fissures. An explorer mayalso 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 thelight should be held as close as possible to the sealant, withoutactually touching the sealant. When set, the sealant forms ahard, opaque film, light yellow in color with a slight surfaceinhibition.

Wipe Clean:

• Wipe the sealant with a cotton applicator to remove the thinfilm on the surface.

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Instructions For Use

Description

3M™ ESPE™ Clinpro™ Sealant is a light-cure, low viscosity, fluoride releasing pit andfissure sealant with a unique patented color change feature. Clinpro sealant is pink whenapplied to the tooth surface, and changes to an opaque off white color when exposed tolight. The pink color helps the dental professional with the accuracy and amount ofmaterial placed during the sealant procedure.

A sealant exhibiting any pink coloring is not completely cured. The color change frompink to off white is not an absolute cure indicator. Therefore, sealant needs to becured 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 ofapproximately 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 theprevention of carries.

Precautions For Dental Personnel And Patients

• Etchant Precautions: 3M™ ESPE™ Scotchbond™ Etching Gel contains 35% byweight phosphoric acid. Protective eyewear for patients and dental staff is recom-mended when using etchants. Avoid contact with oral soft tissue, eyes, and skin. Ifaccidental contact occurs, flush immediately with large amounts of water. For eyecontact, 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 therisk of allergic response, minimize exposure to these materials. In particular, avoidexposure to uncured resin. Use of protective gloves and a no-touch technique is

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recommended. If skin contact occurs, wash skin with soap and water. Acrylatesmay penetrate commonly used gloves. If sealant contacts glove, remove anddiscard glove, wash hands immediately with soap and water then re-glove. Ifaccidental 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 lightsensitive. 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 syringetype dispenser.

2. Prepare delivery system: Remove cap from syringe and SAVE. Twist a disposabletip securely onto the syringe. Holding the tip away from the patient and any dentalstaff express a small amount of material onto a mix pad or 2×2 gauze to assure thedelivery system is not clogged. If clogged, remove the tip and express a smallamount of material form the syringe. Remove any visible plug, if present, from thesyringe opening. Replace syringe tip and again check flow form tip. If clogremains, discard dispensing tip and replace with a new one.

3. At the completion of the procedure remove used syringe-tip and discard. Twist onstorage cap. Storage of the syringe with a used dispensing tip, or without thestorage cap will allow drying or curing of the product and consequent clogging ofthe 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 ADAand CDC for non-immersible dental items. Council on Dental Materials, Instru-ments, and Equipment and Council on Dental Therapeutics, Infection controlrecommendations for the dental office and dental laboratory. JADA 116(2):241-248, 1988).

Bottle

1. Dispense 1 to 2 drops of sealant into the mix well. Immediately slide cover overwell 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 dentalitems as stated under “Syringe #4”.

Disinfect mix well and applicator handles following disinfecting solutionmanufacturer’s recommendations.

Application Guide

The acid etch technique requires care, particularly for isolation and prevention of contami-nation. The enamel to be bonded must be cleaned, and thoroughly washed and dried, andmaintained free from contamination prior to sealant placement.

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Technique

1. Check air/water syringe. Blow a jet of air from syringe onto a glove or mirror. Ifsmall droplets are seen the syringe must be adjusted so only air is expressed. Anymoisture contamination during certain stages of this procedure will compromisethe integrity of a sealant.

2. Select Teeth. Teeth must be sufficiently erupted so that a dry field can be main-tained. The morphology of the pits and fissures should be deep.

3. Clean Enamel. Thoroughly clean teeth to remove plaque and debris from enamelsurfaces and fissures. Rinse thoroughly with water.

Note: Do not use any cleaning medium that may contain oils. If using an air-polish device that utilizes sodium bicarbonate for cleaning, the etching stepshould be repeated a second time, or 3% hydrogen peroxide should be appliedto the surface for 10 seconds to neutralize the sodium bicarbonate, and thenthoroughly rinsed with water prior to applying etch.

4. Isolate Teeth and Dry. While a rubber dam provides the best isolation, cottonrolls used in conjunction with isolation shields are acceptable. Use saliva ejectiondevice or high volume evacuation if possible.

5. Etch Enamel. Apply a generous amount of etchant to all enamel surfaces to besealed, extending beyond the anticipated margin of the sealant. Etch for a mini-mum of 15 seconds, but no longer than 60 seconds.

6. Rinse Etched Enamel. Thoroughly rinse teeth with air/water spray to removeetchant. Remove rinse water with suction. Do not allow patient to swallow orrinse. 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 andwater 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 surfacesis 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 sealantinto 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 helpeliminate any possible bubbles, and enhance the flow into the pit and fissures. Anexplorer may also be used.

Cure the sealant by exposing it to light from a 3M™ ESPE™ Curing Light, or othercuring unit of comparable intensity. A 20-second exposure is needed for eachsurface, 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, opaquefilm light yellow in color with a slight surface inhibition.

9. Evaluate Sealant. Inspect sealant for complete coverage and voids. If surface hasnot been contaminated, additional sealant may be added. If contamination hasoccurred re-etch, rinse, and dry prior to placing more sealant.

10. Dismissal. Wipe the sealant with a cotton applicator to remove the thin stickyfilm on the surface. Check occlusion and adjust as required.

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Questions And AnswersCan I use a bonding agent with 3M™ ESPE™ Clinpro™ Sealant?

Clinpro sealant is not recommended for use with a bonding agent. However, several studieshave been conducted with sealants and bonding agents. This technique has been shown tobe useful when applying sealant to teeth that are difficult to keep isolated and there isconcern about moisture contamination.18,19

If using a high power curing light, how many seconds are needed to cureClinpro sealant?

3M ESPE lab testing showed Clinpro sealant required the following cure times to pass thedesired Barcol hardness test rating of 30, or higher, on both the top and bottom of preparedsamples:

• 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 thisanswer.

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 non-fluoridated polishing pastes.20

A study on estrogenicity of resin based dental composites and sealants has raisedcontroversy and concern about the safety of monomers (Bisphenol-A generatedfrom Bis-DMA) leached out of these materials. Bisphenol-A has the potential toemulate the hormone estrogen.8 Is Clinpro sealant in this category?

Several 3M ESPE products contain BIS-GMA, which is a different molecule from Bis-DMA.

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 ahigher level of air inhibition. The ADA requires an uncured film thickness of not more than0.1µm. Clinpro sealant has an uncured film thickness of .04µm.

Because you are etching the enamel beyond where the sealant will be placed, willthis exposed etched enamel now be more susceptible to caries?

The caries process on the occlusal surface is initiated within the fissures not on the cuspalinclines. In addition it has been shown that etched enamel remineralizes completely within48 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, theydo not always reimburse the dental professional if a sealant needs to be replaced.

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What is a preventive resin restoration?

The preventive resin restoration is the conservative answer to conventional “extension forprevention” philosophy of Class I amalgam cavity preparation. Extension for preventiondictates that the outline form of the cavity preparation be extended beyond the margins ofthe cavity to incorporate all susceptible pits and fissures. Using composite resin restor-atives, bonding agents, and unfilled resin materials instead of amalgam does provide for amore conservative preparation. This extension prevents future caries formation, but does soat the expense of losing some healthy tooth structure. The technique and compositematerials used for this procedure can have several variations.

Comparison of Sealant Features

Brand % Fill Fluoride Shelf Life Application Color Other

Clinpro™ Sealant 6 Y 24 mo. Syringe-1.2ml White Changes3M™ ESPE™ Bottle-6ml color

UltraSeal XT®Plus™ 60 Y 24 mo. Syringe-1.2ml White AdditionalUltradent® refrigerate Translucent ingredient/step

A2 Prima DryRadiopaque

Helioseal® F 43 Y 36 mo. Unit dose-.08ml ea. White Must waitIvoclar-Vivadent Syringe-2.5gm 15 seconds

Bottle-8ml before cure

Delton® FS+ 55 Y 18 mo. Unit dose-.08ml ea. White RadiopaqueDentsply/Chalk Syringe-1.9g Clear

Delton® DDS * N 24 mo. Unit dose-.08ml ea. White *Dentsply/Chalk Clear

Seal-Rite™ 8 Y 18 mo. Syringe-1.2ml White Also availablePulpdent high viscosity

34% filled

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Kit Contents

3M™ ESPE™ Clinpro™ Sealant

Clinpro Sealant Clinpro Sealant Clinpro Sealant Clinpro SealantIntroduction Kit Refill Introduction Kit RefillSyringes Syringe Bottles Bottle

2 - 1.2 ml 1 - 1.2 ml 2 - 6ml 1 - 6mlsealant syringe sealant syringe sealant bottles sealant bottle

1 - 3ml syringe 1bag - 10 count 1 - 9ml bottle 1 - instructions35% acid etch gel black sealant 35% acid etch gel

syringe tips

2 bags - 10 count 1 - instructions 1 bag - 60 countblack sealant sealant brush tipssyringe tips

1 bag - 25 count 2 bag - 50 countblue etchant syringe tips etchant fiber tips

1 – instructions 2 - brush handles

1 black covered mixwell

1 – instructions

SummaryThe following is a summary of the features of 3M™ ESPE™ Clinpro™ Sealant:

• Sealant is pink, then changes to white when cured

• Color change makes it easy to control and visualize placement.

• Releases fluoride.

• Contains a patented organic fluoride.

• Off white opaque color for ease of re-evaluation.

• Easy to use syringe dispenser.

• Ultra-fine syringe tip for controlled dispensing.

• Fewer bubbles seen.

• Fewer occlusal adjustments than a filled sealant.12

• Familiar conventional sealant technique.

• Available in both syringe and bottle.

• Easy to understand instructions.

Warranty

3M ESPE will replace products that are proved to be defective. 3M ESPE does not acceptliability for any loss or damage direct or consequential arising out of the use of or theinability to use the products. Before using, the user shall determine the suitability of theproduct for its intended use and user assumes all risk and liability whatsoever in connectionwith use of this product.

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References1. 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 Thera-peutics: Pit and fissure sealants. J Am Dent Assoc 93:134, 1976.

4. Simonsen R: Retention and effectiveness of dental sealant after 15 years. JADA1991;122:34-43.

5. American Dental Association, Council on Dental Materials, Instruments, andEquipment. Pit and Fissure Sealants. J Am Dent Assoc 114:671, 1987.

6. Mejare I. Mjor IA: Glass ionomer and resin-based fissure sealants: A clinicalstudy. Scand J Dent Res 1990; 345-350.

7. Torppa-Saarinen E, Seppa L:Short-term retention of glass-ionomer fissure seal-ants. Proc Finn Dent Soc 1990; 86:83-88.

8. Olea N, Pulgar R, Perez P, et al.: Estrogenicity of resin-based composites andsealants 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 fissuresealants in primary molars: an SEM study. J Clin Pediatr Dent 1994; 18(3):187-190.

11. Park K, Georgescu M, Scherer W, Schulman A. Comparison of shear strength,fracture patterns and microleakage among unfilled, filled and fluoride-releasingsealant. Pediatr Dent 1993; 15:418-20.

12. Boksman L, McConnell RJ, Carson B, et al. A 2-year clinical evaluation of two pitand fissure sealants placed with and without the use of a bonding agent. Quintes-sence Int 1993; 24(2):131-3.

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