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ClinproTM Sealant

Technical Product Profile

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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

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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

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clinical study done on sealant retention, the following percentages were recorded over the years with 3MTM ESPETM ConciseTM 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.

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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

3MTM ESPETM ClinproTM 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

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Composition

Listed below are the components of the 3MTM ESPETM ClinproTM Sealant and their functions.

Component

Common Name

Function

Bisphenol A Diglycidyl methacrylate Triethylene glycol dimethacrylate Ethyl 4(dimethylamino)benzoate Diphenyliodonium hexafluorophosphate DL-Camphorquinone Butylated hydroxytoulene Dichorodimethylsilane reaction product with silica Tetrabutylammonium tetrafluoroborate Titanium Dioxide Rose bengal sodium

Bis-GMA TEGDMA EDMAB I+ CPQ BHT Silane treated amorphous silica TBATFB TiO2 C. I. 45440

Matrix resin monomer Matrix resin monomer Component of the photo-initiator system Component of the photo-initiator system Component of the photo-initiator system Stabilizer, radical scavenger Reinforced inorganic filler with a particle size of .016 micrometers Fluoride releasing source Provides white color Adds color before curing

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Physical Properties

3MTM ESPETM ClinproTM 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

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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 3MTM ESPETM ClinproTM Sealant in comparison with other competitive sealant products, namely Ultraseal® XT PlusTM, Helioseal F®, and Delton Plus®.

900

Micrograms fluoride/gram sample

Figure 2. Cumulative Fluoride Release

800 700 600 500 400 300 200 100 H F F J J FJ F J B BJ J F B BBB F 0H J 0 F J B H H H H F J B 100 H H B J H

H

H

Ultraseal Helioseal F

H F

Delton Plus Clinpro Sealant

F J B 200 Days

F J B 300

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Evaluations

Numerous in-vitro evaluations were done on prototypes of 3MTM ESPETM ClinproTM 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.

Placement Accuracy

92 92 89 85 85 88

Figure 3. Percentage of 4 and 5 ratings for 3MTM ESPETM ClinproTM Sealant

Color Change Overall Handling Flow of Sealant Syringe Dispenser Etchant Performance 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 3 2 1=poor 0 10 20 % 30 40

}

77%

50

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Technique Guide

FISSURES

Indications:

· 3MTM ESPETM ClinproTM 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 3MTM ESPETM 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

3MTM ESPETM ClinproTM 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: 3MTM ESPETM ScotchbondTM 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: 3MTM ESPETM ClinproTM 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

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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. 2. Protective eyewear is recommended for patients and staff when using a syringe type dispenser. 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. 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. 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).

3.

4.

Bottle

1. 2. 3. 4. Dispense 1 to 2 drops of sealant into the mix well. Immediately slide cover over well to protect from light. Re-cap sealant bottle. After removing material from well always replace cover slide. 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.

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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. 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. 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. 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. 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. 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 3MTM ESPETM 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.

2. 3.

5.

6.

7.

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

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Questions And Answers

Can I use a bonding agent with 3MTM ESPETM ClinproTM 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: · · ApolloTM 95E, a plasma arc curing system by DMD, required a 3-second cure time. AccuCure 3000TM 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.

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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

ClinproTM Sealant 3MTM ESPETM UltraSeal XT®PlusTM Ultradent®

% Fill Fluoride

6 Y

Shelf Life

24 mo.

Application

Syringe-1.2ml Bottle-6ml Syringe-1.2ml

Color

White

Other

Changes color Additional ingredient/step Prima Dry Radiopaque Must wait 15 seconds before cure Radiopaque

60

Y

24 mo. refrigerate

White Translucent A2

Helioseal® F Ivoclar-Vivadent

43

Y

36 mo.

Unit dose-.08ml ea. Syringe-2.5gm Bottle-8ml Unit dose-.08ml ea. Syringe-1.9g

White

Delton® FS+ Dentsply/Chalk

55

Y

18 mo.

White Clear

Delton® DDS Dentsply/Chalk Seal-RiteTM Pulpdent

*

N

24 mo.

Unit dose-.08ml ea.

White Clear White

*

8

Y

18 mo.

Syringe-1.2ml

Also available high viscosity 34% filled

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Kit Contents

3MTM ESPETM ClinproTM 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 - 3ml syringe 35% acid etch gel 2 bags - 10 count black sealant syringe tips

1 - 1.2 ml sealant syringe 1bag - 10 count black sealant syringe tips 1 - instructions

2 - 6ml sealant bottles 1 - 9ml bottle 35% acid etch gel 1 bag - 60 count sealant brush tips 2 bag - 50 count etchant fiber tips 2 - brush handles 1 black covered mixwell 1 ­ instructions

1 - 6ml sealant bottle 1 - instructions

1 bag - 25 count blue etchant syringe tips 1 ­ instructions

Summary

The following is a summary of the features of 3MTM ESPETM ClinproTM 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 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.

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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. Mertz-Fairhurst EJ, Schuster GS, Fairjurst CW: Arresting caries by sealants: Results of a clinical study. JADA 1986,112;194-197. ADA Council on Dental Materials and Devices and the Council on Dental Therapeutics: Pit and fissure sealants. J Am Dent Assoc 93:134, 1976. Simonsen R: Retention and effectiveness of dental sealant after 15 years. JADA 1991;122:34-43. American Dental Association, Council on Dental Materials, Instruments, and Equipment. Pit and Fissure Sealants. J Am Dent Assoc 114:671, 1987. Mejare I. Mjor IA: Glass ionomer and resin-based fissure sealants: A clinical study. Scand J Dent Res 1990; 345-350. Torppa-Saarinen E, Seppa L:Short-term retention of glass-ionomer fissure sealants. Proc Finn Dent Soc 1990; 86:83-88. 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. Fung, EY., et al. Pharmacokinetics of bisphenol A released from a dental sealant. JADA 2000 131(1):51-58.

2. 3. 4. 5. 6. 7. 8. 9.

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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