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A

Why has it taken so long for ACP to enter the market?

If calcium phosphate is such hot stuff, why has it taken so long to find its way into dental products? It's not as simple as dabbing minerals straight onto teeth, Dr. Tung explains, because in solid form they won't bind to the teeth. Instead, he has worked with a compound called amorphous calcium phosphate (ACP) which, when combined with water, crystallizes onto the teeth in the form of new enamel.

The Australian team, led by Eric C. Reynolds, AO, head of the school of dental science at the University of Melbourne, Australia, took a different approach to ACP. They noticed that milk products seemed to have beneficial effects on tooth enamel and realized that casein phosphopeptides (CPP) could stabilize the molecules until they are applied to teeth, and help bind them to plaque, bacteria, soft tissue, and dentin where they are slowly released to form enamel. The Australians have licensed their formula for CPP-ACP to GC America, which sells it as MI Paste in the United States and Canada and Tooth Mousse elsewhere.

 

Does MI Paste have the ADA Seal of Acceptance?  What is the ADA Seal of Acceptance Program? 

The ADA decided not to utilize the seal program for prescription products after January 1, 2008.  The ADA instituted the Professional Product Review (PPR) in place of the seal program for this category.  The PPR is provided free to ADA members (and by subscription to others) four times a year and includes comparative evaluations of a number of products in a category with usually three product categories per issue.  The ADA concurrently made the decision to concentrate on the PPR and to eliminate the Seal Program for professional and prescription products.  Consequently, professional and prescription products are no longer eligible for the ADA Seal of Acceptance. 

However, the Seal Program for consumer products remains in place to continue to help consumers make informed consumer product decisions.  When consumers see the ADA Seal on a product, they can be assured that it has undergone a rigorous objective, scientific review of its safety and effectiveness.  The Seal on product labeling means that the product says what it does and does what it says.  Although it is strictly voluntary, more than 100 companies participate in the Seal program.  Participating companies commit significant resources to test and market products in the Seal program.  More than 400 dental products that are sold to consumers carry the Seal of Acceptance.  These include toothpaste, dental floss, manual and electric toothbrushes, mouth rinse and chewing gum.

ADA Seal page 
List of ADA Seal of Acceptance for consumer products. 

 

How to apply MI Paste PLUS?

Just like MI Paste, MI Paste PLUS is applied topically to at-risk surfaces. This can be done by first cleaning the teeth and then smearing a small amount of MI Paste PLUS across the tooth surfaces with a clean finger or cotton-tipped applicator.

When applied immediately before bed, the material is then left in place, to dissolve slowly overnight. It is not rinsed out. MI Paste PLUS can also be applied topically to the teeth using a custom-made tray such as a pull-down tray made for applying a whitening gel.

• Apply using a clean finger or custom tray
• Leave undisturbed for a minimum of three minutes
• Spread around the mouth and teeth with the tongue and hold for one to two minutes
• Expectorate, do not rinse and avoid food or drink for 30 minutes
• How often to apply?
  • Nightly application is the standard recommendation
  •  For high risk patients, apply both morning and night

B

Will MI Paste alleviate sensitivity from bruxism?

The occlusion or bite is causing the sensitivity and until that is corrected MI paste will not eliminate the sensitivity.  The sensitivity is due to the occlusion and the clenching and unfortunately MI Paste would probably not alleviate the sensitivity. 

Can you brush on MI Paste?

MI Paste should be applied with cotton swab, gloved or clean finger or with a custom tray.  Brushing is not recommended to applying MI Paste.

How soon after I brush do I apply MI Paste?

After brushing with an over the counter toothpaste (1,000 ppm fluoride) immediately apply a pea-size amount of MI Paste to the tooth surfaces using either a clean finger or a cotton swab. 

Does MI Paste/MI Paste PLUS contain Bis-Phenol A (BPA)?

Considering the recent inquiries we would like to confirm that GC dental products sold in the United States of America, Canada or Latin America do not contain Bis-Phenol A (BPA) as an ingredient. Also GCA does not import any products into the United States of America, Canada or Lat America containing Bis-GMA.

 

C

Is MI Paste PLUS safe to use on children?

Because MI Paste PLUS contains a level of fluoride similar to that of adult strength toothpastes, there are issues when the material is ingested either accidentally or deliberately in children because of their low birth weight. Ingestion of a pea-size amount (0.5mL) of MI Paste PLUS will contribute 0.45mg of fluoride ion to the daily fluoride intake.

In young children (up to six years of age), use of MI Paste PLUS is contra indicated because it may increase the risk of dental fluorosis. Children aged six years and above can use both standard (adult strength) toothpaste (1000ppm) and MI Paste PLUS without an increased risk of dental fluorosis.

CAUTION

• MI Paste PLUS contains 0.2% (900ppm) fluoride. It is not recommend for children under six.
• It is not recommended for overnight application in children under 12.
• Do not use on patients with a milk protein allergy (caesin IgE) and/or sensitivity to benzoate preservatives

Why is calcium so important? 

It is critical to sustain the bio-available calcium ion level within the saliva, to remineralize the tooth structure before attempting to restore it. Using fluoride products alone is insufficient to cause remineralization or prevent severe demineralization from occurring, because the critical pH of enamel relates strongly to the calcium concentration in the saliva and the plaque fluid. To maintain as high a level of calcium in the plaque fluid as possible, apply MI Paste PLUS each morning and again each night, immediately before retiring. This contains and releases calcium, phosphate and fluoride ions in the correct ration (5:3:1) for optimal remineralization of tooth structure.  

If a patient is a high caries risk, a home program may continue to include high fluoride concentration toothpaste or gel on an intermittent basis to suppress plaque levels and suppress plaque fermentation. Use a detergent-free normal strength toothpaste morning and night, but a high strength (5000 ppm) fluoride toothpaste or gel (9000 ppm) in the middle of the day, in order to exert antibacterial effects, and to prevent potential problems with sequestering calcium ions.   

Why not to use antimicrobial rinse such as chlorhexidine gluconate within 2 hours of using fluoride toothpaste containing sodium lauryl sulfate?

It is suggested not to use antimicrobial rinses, such as chlorhexidine gluconate (CHA) or cetylpyridinium chloride (CPC) within 2 hours of fluoride toothpaste containing sodium lauryl sulfate because the sodium laurel sulphate saponification component in dentifrice can reduce chlorhexidine activity.. 

What is Cetylpyridinium Chloride (CPC)

CPC is a cationic quaternary ammonium compound in some types of mouthwashes, toothpastes, lozenges, throat sprays, anti-snore throat sprays, breath sprays, and nasal sprays. It is an antiseptic that kills bacteria and other microorganisms. It has been shown to be effective in preventing dental plaque and reducing gingivitis. It has also been used as an ingredient in certain pesticides. This ingredient has also been shown to cause brown stains between the teeth.

CPC has a positive cationic (Sodium Laurel Sulfate is negative) resulting in negating the desired effect.     

Crest Pro-Health Rinse contains CPC, how does it work? 

Crest Pro-health Rinse contains a clinically proven bactericidal agent, CPC that’s attracted to bacteria in the mouth. CPC interacts with the bacterial membrane and weakens it. The cellular pressure disrupts the cell membrane and kills the bacteria.  

What is the protocol with Chlorhexidine Gluconate and MI Paste? 

It is suggested to wait 2 - 3 hours after rinsing with antimicrobial rinses, such as chlohexidine gluconate (CHX) or cetylpyridinium chloride (CPC) before applying MI Paste. Chlorhexidine gluconate adheres to the tooth surface just as MI Paste, so it is best to wait 2 - 3 hours before applying MI Paste after rinsing with CHX.  

What goes first? How long should a patient wait between applying Chlorhexidine Gluconate (CHX) and MI Paste and will they affect each others efficiency?

It is best to wait 2-3 hours after rinsing and applying MI Paste. As to which goes first the order is not the important factor just that there is sufficient time between applications.

How young can a child be to apply MI Paste?

MI Paste is a safe product to use for babies’ teeth and is well tolerated by children and tastes delicious. MI Paste is especially useful for children under 2 years of age, where toxicological issues mean normal or high strength fluoride products are contraindicated.

MI Paste is a safe product to use for babies' teeth and is well tolerated by children and tastes delicious. RECALDENT™ (CPP-ACP) is derived from the milk protein casein called casein phosphopeptide. Do not use on patients with the milk protein casein allergy. 

Newly erupted teeth have yet to complete their enamel maturation and until this occurs they are more vulnerable to an acid attach. Boosting levels of calcium and phosphate in the saliva facilitates the normal post-eruption maturation process and replaces any mineral lost on a daily basis. RECALDENT™ (CPP-ACP) is derived from cow's milk and is ideal for protecting deciduous teeth at a time when oral care is difficult.

MI Paste is applied to the teeth twice daily with a clean finger to provide a surface film that will raise levels of essential minerals (calcium and phosphate), as well as inhibit the growth of caries causing bacteria.

 At what age can children use MI Paste PLUS? 

MI Paste PLUS, which contains 900 ppm fluoride ions (0.2% sodium fluoride), is not recommended for children under six years of age.

Is there an increase in supra-gingival calculus associated with the use of MI Paste? 

Casein Phosphopeptides (CPP) inhibits the transformation of amorphous calcium phosphate into crystalline phases (Holt and van Kemenade, 1989) such that they should not directly promote calculus formation but instead provide a plaque reservoir of soluble calcium phosphate ions capable of diffusing into subsurface enamel and promoting remineralization. 

How much calcium is in MI paste? 

The amount of calcium contained in MI paste is 13mg/g. 

Canker sores and MI Paste

Canker sores are shallow, painful sores in the mouth. They are usually red or may sometimes have a white coating over them. You might get them on the inside of your lips, the insides of your cheeks, the base of your gums or under your tongue. Anyone can get canker sores, but women and people in their teens and 20s get them more often. Canker sores may run in families, but they aren't contagious. Doctors don't know what causes canker sores, but they may be triggered by stress, poor nutrition, food allergies and menstrual periods. The acid from strawberries and tomatoes may also be a contributing factor. 

MI Paste/MI Paste PLUS does not have any history of causing canker sores. Hydroxybenzoate, often called paraben and is widely used as a preservative in the cosmetic and pharmaceutical industries, such as shampoos, lotions, toothpaste, etc. It is also used as a food additive. Parabens are considered to be safe, but can cause skin irritation or dermatitis on some individuals with paraben allergies.

With that in mind, that is why the caution statement is posted on the box: "RECALDENT™ is derived from milk casein. Do not use on patients with a milk protein and/or hydroxybenzoate allergy. "

It is suggested that the patient temporarily stop using MI Paste/MI Paste PLUS until the canker sores have healed. Once the canker sores have healed, the patient may want to resume applying MI Paste PLUS. As mentioned above, it could be caused from stress, nutrition or food allergies, not relating to MI Paste PLUS. It is always wise to check with a physician or dentist.

D

Why not use MI Paste/MI Paste PLUS as a dentifrice?

The reason why you wouldn't want to use it as a dentifrice is because it is "sticky" which gives it the substantivity. Having the milk protein in it, with most toothbrushes, more of it will stick to the bristles of the brush than when you use the tray or finger technique.

The patient would be wasting too much product in the bristles of the toothbrush and not on the tooth surfaces. We want the patient to get the most use out of her tube of MI Paste. Also, most people rinse after brushing and again this would defeat the benefit of MI Paste.

I am not a dentist, my dentist prescribed MI Paste but I can't find a pharmacy that can fill the prescription, what do I do? 

As a company we do not sell direct, MI Paste is only sold to the dental profession through their dental dealer. If your dentist prescribed MI Paste more than likely he will have it in his office. Your dentist can always purchase MI Paste through his local dental dealer.

Can a patient on kidney dialysis use MI Paste? 

The amount of phosphate contained in MI Paste 40g tube is more than 0.2%. We say “more than” because 0.2% is phosphoric acid by itself and CPP-ACP also contains phosphate. 

GCC does not recommend using MI Paste on dialysis patients, although the amount of ingestion of phosphate by using MI Paste would be very small.

We do not recommend kidney dialysis patients to use MI Paste. Although the amount of ingestion of phosphate is very small we do not recommend its use.  

We do not show a warning about phosphate for dialysis patients in the IFU. Instead, we show all the ingredients on the tubes and boxes.   

 

E

Can MI Paste be used on patients with dental erosion?

MI Paste is extremely effective at remineralizing erosion areas, and can be used in patients who have gastro esophageal reflux disease or eating disorders such as bulimia in order to protect these areas from dental erosion. If the saliva in the mouth is of good quality, as shown by saliva profiling, then fluoride is able to promote limited remineralization because calcium and phosphate is present.

However, fluoride will ineffectively remineralize teeth if the salivary flow is inadequate, because of the low levels of calcium and phosphate. MI Paste provides bio-available calcium and phosphate ions at the tooth surface at much higher levels than can be maintained by normal salivary flow. Therefore MI Paste is recommended even for patients with normal salivary flow.

F

Why add fluoride to MI Paste? 

MI Paste PLUS exhibits significantly greater anti-caries properties than its fluoride content alone, it is a superior product for professional application or at-home use. CPP-ACPF (MI Paste PLUS) gives greater anti-caries effects than CPP-ACP (MI Paste), and is designed for patients at high risk for dental caries and dental erosion. Even though the pH of MI Paste PLUS is above 7.0, it enhances mineral uptake without encouraging the formation of calculus.

The mechanism of anti-cariogenicity for CPP-ACPF involves elevating levels of calcium, phosphate and fluoride ions at the tooth surface and within dental plaque, thereby depressing enamel demineralization and enhancing remineralization. The increases in supragingival plaque levels of calcium, phosphate and fluoride ions produced by CPP-ACPF are markedly greater than those obtained with 1000ppm fluoride toothpastes.

 

How does fluoride and CPP-ACP work? 

FLUORIDE AND CPP-ACP
Four Fluoride ions promote the formation of fluorapatite in the presence of calcium ions and phosphate ions. This is now believed to be the major mechanism of fluoride ion’s action in preventing tooth decay. However, fluoride ions can only promote remineralization of tooth enamel with fluorapatite if enough salivary or plaque calcium and phosphate ions are available when the fluoride is topically applied. Hence, on topical application of fluoride ions, the availability of calcium ions and phosphate ions are the limiting factor for net enamel remineralization to occur (Ten Cate, 1999). MI Paste PLUS is a superior form of fluoride ions as it also contains CPP-ACP. MI Paste PLUS therefore contains bio-available calcium ions, phosphate ions and fluoride ions. CPP-ACP plus fluoride has been shown to increase fluoride’s uptake into plaque and subsurface enamel and substantially increase subsurface enamel remineralization in situ with fluorapatite relative to fluoride alone, by providing bio-available calcium ions, phosphate ions and fluoride ions in the correct molar ratio to form fluorapatite.

 

How much fluoride is in MI Paste PLUS?

MI Paste PLUS contains 900 parts per million (ppm) fluoride ions a level just below that found in normal adult-strength toothpastes (1000ppm). While the remineralizing actions of the fluoride ions are well known, MI Paste PLUS with ACPF releases fluoride as well as calcium and phosphate ions, thereby providing all the three ions which are required for formation of acid-resistant fluorapatite. This level of fluoride also exerts some effects on the utilization of sugars as an energy source by dental plaque bacteria, which reduces their overall contribution to plaque fermentation.

How is fructose metabolized? 

It is desirable to minimize patients' high frequency consumption of fermentable dietary substrates, including those in foods, drinks, and medications. Nonfermentabel dietary sweeteners are recommended whenever possible, such as xylitol, sorbitol, aspartame or saccharin. The polyols such as xylitol are anticariogenic as they result in decrease acid fermentation by S. Mutans. 

Fructose is a monosaccharide, or single sugar, that has the same chemical formula as glucose but a different molecular structure. Sometimes called fruit sugar, fructose is found in fruit, some vegetables, honey, and other plants. Fructose and other sugars are carbohydrates, an important source of energy for the body.

Does MI Paste/MI Paste PLUS have FDA 510K Clearance? 

MI Paste received FDA 510K Clearance to sell and market MI Paste on October 20, 2004 (KO42200). MI Paste PLUS received FDA 510K Clearance on April 12 2007 (KO70854). Both MI Paste and MI Paste PLUS have FDA 510K Clearance as a prophy paste and for treating hypersensitivity.

MI Paste is cleared in Canada by Health Canada, MI Paste PLUS is pending.

Recommended Indications:
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. Secondarily, MI Paste/MI Paste PLUS can be used for the management of tooth sensitivity, post scaling, root planing and bleaching.

Note the FDA does not give approvals but clearance based on the data submitted.

510K Clearance
MI Paste - K042200
MI Paste PLUS - K070854

Is MI Paste/MI Paste PLUS approved by the FDA?

Yes GC America received clearance to sell and market MI Paste on Oct. 20, 2004, K042200
MI Paste PLUS received clearance to sell and market on April 12, 2004, K070854
MI Paste is cleared in Canada by Health Canada, MI Paste PLUS is pending

Why does MI Paste only come in mixed flavors when most patients prefer mint?

MI Paste is only available in an assorted pack (melon, mint, vanilla, strawberry and tutti-frutti). MI Paste PLUS is available in an assorted pack and in a mint only 10-pack. 

A patient is allergic to strawberries, can they use MI Paste strawberry flavor? I know the flavor comes from artificial flavoring, but I am not sure if real fruit is used at any point.

MI Paste's flavoring agent is artificial. No real fruit is used in the flavoring process.

 

Is fluoride necessary for enamel to uptake calcium and phosphate ions?

Fluoride is beneficial but not necessary for the calcium and phosphate ion to be beneficial to the tooth substrate.

Is it okay to rinse with fluoride prior to using MI Paste instead of fluoride toothpaste?

Brushing with 900/1000 ppm toothpaste is acceptable and than apply MI Paste. If using a high strength toothpaste (5000 ppm or more) it is suggested to wait at least 2 hours before applying MI Paste. The same goes for rinsing with a high fluoride rinse.    

Is toothpaste or fluoride rinse to be rinsed after use or just spit out to maximize the amount of fluoride available?

Brush your teeth with your regular toothpaste 900 ppm, including spitting and rinse the mouth, than apply MI Paste. 

What type of fluoride is better to combine with MI Paste, stannous or sodium fluoride?

One fluoride is not better than the other. Stannous fluoride has a tendency to stain, which is why sodium fluoride is more popular. Do not combine, separate applications especially if using a high fluoride product like Prevident. A suggestion, have the patient use the high fluoride in the AM and MI Paste in the PM. Again with the high dose you want to separate treatment, you may want to wait 2 - 3 hours.

Should MI Paste be used after every fluoride treatment?

Yes, studies at the University of Melbourne have demonstrated that RECALDENT™ CPP-ACP significantly increased the uptake of fluoride into the tooth enamel creating fluorapatite that is more resistant to acid challenge. Thus MI Paste is recommended for treatment of patients of both high and low caries risk.

In terms of a patient who has a low caries risk, a six monthly application of neutral sodium fluoride gel followed by MI Paste is recommended.

In patients who use no fluoride products, RECALDENT™ CPP-ACP will still be effective, since in all patients there are halo effects of fluoride in the water and in their diet. CPP-ACP is able to remineralize tooth structure in the complete absence of fluoride, and this is through the formation of hydroxyapatite.

 

Is MI Paste an alternative to fluoride for anti-fluoride patients?

Yes. The fact that MI Paste is derived from the milk protein, casein, it is completely natural and safe and therefore is often an effective preventive treatment for patients who are anti-fluoride.

G

Grinding, Sensitivity and MI Paste

Please talk with your dental professional about grinding and what can be done to help alleviate the discomfort. MI Paste can be used for patients with aggressive tooth wear, where the tooth surfaces have become sensitive. Please keep in mind, MI Paste will not replace the enamel you wore down. MI Paste will help to remineralize the enamel you have left and help to reduce sensitivity.

Does MI Paste or MI Paste PLUS contain Gluten? 

We confirm that MI Paste/MI Paste PLUS does not contain gluten. It contains nothing other than the ingredients listed on the tube and box. 

Why is propylene glycol in MI Paste/MI Paste PLUS?

Propylene glycol is used in oral pastes as a thickening agent. It is digestible and the body turns it into lactic acid. Propylene glycol is safe and is listed by the FDA as GRAS (generally regarded as safe.) Diethylene glycol is toxic.

H

With so many other options available for dentinal hypersensitivity, why MI Paste?

When MI Paste with RECALDENT™ (CPP-ACP) is applied onto the surface of dentin, the protein component bonds strongly and subsequently mineral plugs form, which begin to block the tubules. Several clinical studies have shown that MI Paste has a potent long acting desensitizing effect when used in patients with cervical sensitive dentin.

MI Paste with RECALDENT™ (CPP-ACP) applied at least once daily provides both immediate and long term solutions to the common problem of dentinal hypersensitivity. It can arrest the process of dental erosion, which is a common underlying cause of chronic tooth sensitivity.  

What is a hydroxybenzoate allergy? 
What sort of products contain hydroxybenzoate?  
How would someone know if they are allergic to hydroxybenzoate? 
Is hydroxybenzoate in food, sunscreen? 
Is hydroxybenzoate a preservative?

Para-hydroxybenzoate is often called as Paraben and is widely used as preservatives in the cosmetic and pharmaceutical industries, such as shampoos, lotions, toothpaste etc. They are also used as food additives. Parabens are considered to be safe, but can cause skin irritation or dermatitis on some individuals with paraben allergies.

Should a patient consider incorporating MI Paste into their daily dental homecare? 

The MI Paste protocols are intended for moderate to high risk patients. However, keep in mind that demineralization/remineralization is occurring continuously in the mouth. Once you have reversed the negative effects of demineralization you will need to maintain a healthy oral cavity. If a patient has experienced demineralization problems in the past, the patient can only benefit from incorporating MI Paste into their daily dental routine. Just as we have continuous exposure to fluoride we need the continuous exposure of calcium and phosphate in MI Paste.

K

Kidney Disease - MI Paste/Dialysis Patient

MI Paste protocol sheet, it says you should "Contact a physician if recommending MI Paste for a renal dialysis patient." Why is this?

People with kidney disease are susceptible to an imbalance of phosphorus and calcium. During normal renal function the body is in homeostasis; however, during kidney disease the body is not able to remove phosphorus well. Phosphorus builds up in the blood and sends a signal to the parathyroid glands to emit parathyroid hormone which triggers an increase in calcium within the blood. The best source of calcium is in the bones; therefore, the bones can become less dense (thinning of the lamina dura and pulp chamber are often observed in the dialysis patient). At this point we have a lot of phosphorus in the blood - which puts the patient at high risk for heart attack. Also, we have a lot of calcium in the blood - this condition is known as secondary hyperparathyroidism or Renal Osteodystrophy. The excess calcium can be deposited into blood vessels, heart, lungs, liver, and other soft tissues. Calcium can get so high that it causes Calcinosis a very serious condition. Obviously, adding more phosphorus or calcium to the diet to a dialysis patient can be a problem (even a considerably small amount). MI Paste has phosphorus and calcium in it.

Of course, since it is only used topically, that raises some questions - how much would be ok or how much would be lethal (or damaging). The answer to this, simply, is every patient is different and each patient could vary from day to day or week to week (they're monitored weekly or monthly, dependant on their needs/stability). Consulting with the renal specialist can be confusing because there are 5 stages of kidney disease and the phosphorus/calcium thing is more important in some stages than others. With that said, understanding the disease process of the population will help you when discussing the patients needs when communicating with the nephrologist, renal nurse, or renal dietitian.
Remember, if approved by the medical team, the issue can be the helped by recommending the use of MI Paste correctly by using a small amount. If you spit out the excess you will likely be in good shape. GC America is trying to be cautious and make people aware and that's always a good thing.

The salivary chemistry of renal patients does not favor caries infections so that's something to consider too. If you do a saliva test and it comes back buffering off the charts and a very high pH caries may be off the worry list. However, you are now aware that MI Paste is not only of value for caries but a list of other conditions; therefore, you'll still may want to consider the use MI Paste for palliative care of the intense xerostomia dialysis patients have (etc.).

Comments provided by:
Shirley Gutkowski, RDH, BSDH
www.shirleygutkowskirdh.com
Integrating Oral Health with Systemic Health

Cher Thomas, RDH
www.dentalinspirations.org
Specializing in Dental Treatment for Patient's Living with Renal Disease

L

Does MI Paste contain lactose?

MI Paste/MI Paste PLUS contains RECALDENT™ (CPP-ACP), it is milk derived with lactose content less than 0.01%. The amount is very small.

M

Does MI Paste/MI Paste PLUS have melamin, do they use milk from China to create MI Paste?

The milk used to create RECALDENT™ CPP-ACP comes from the dairy cows of New Zealand. The milk does not originate from China. We appreciate your concern for safety and assure you that MI Paste/MI Paste PLUS does not contain melamine.

When To Use MI Paste PLUS Rather Than MI Paste?

MI Paste PLUS is recommended at night for patients with marked salivary dysfunction (dry mouth), for example, because of medications, systemic illnesses, or salivary gland disease, because of the enhanced risk of mineral loss from dental caries or dental erosion. These patients would also benefit from daytime applications of GC Dry Mouth Gel to gain symptomatic relief from oral dryness. Patients should be at least six years of age before using MI Paste PLUS.

Regular MI Paste, which is fluoride-free, is the appropriate product to use in infants and young children (up to six years of age) because of issues with fluoride ingestion.

• Patients with active caries
• Patients with poor plaque control
• Patients with erosion and gastric reflux
• Xerostomic patients
• Patients with an acidic oral environment
• Medically compromised patients
• Desensitizing
• White spot lesion
• Pregnant mothers
• Orthodontic treatment (during and after)
• High caries risk patients
• Extra protection for teeth

Is MI Paste/MI Paste PLUS safe for patients with milk allergies? 

The active ingredient in MI Paste/MI Paste PLUS is RECALDENT™ (CPP-ACP).RECALDENT™ (CPP-ACP) is milk derived and should not be used by patients with milk protein allergies. Casein phosphopeptides are derived from milk casein. Do not use MI Paste/MI Paste PLUS if you have a proven or suspected milk protein (IgE)allergy.

 

What separates MI Paste from other calcium products?

RECALDENT™ (CPP-ACP) technology has been extensively researched at the University of Melbourne Dental School (Australia) since the 1980’s. There are over 100 studies substantiating the benefits of RECALDENT™ (CPP-ACP), the active ingredient in MI Paste. 

 

 What is MI Paste PLUS?

MI Paste PLUS contains a unique, patented form of fluoride in a product designed for high-risk patients. It has all the benefits of MI Paste with enhanced remineralizing capabilities.

MI Paste PLUS provides a superior form of fluoride ions as it also contains CPP-ACP (casein phosphopeptide-amorphous calcium phosphate). CPP-ACP + fluoride (F) has been shown to increase fluoride’s uptake into plaque and subsurface enamel and substantially increase subsurface enamel remineralization in situ with fluoroapatite relative to fluoride alone, by providing bio-available calcium, phosphate and fluoride ions in the correct molar ratio to form fluoroapatite in the body of the lesion, not just at the surface layer. CPP-ACPF (MI Paste PLUS) gives greater anti-caries effects than CPP-ACP (MI Paste) and is designed for patients at high risk for dental caries and dental erosion.

For children under six years of age, the use of the regular MI Paste is recommended to provide the protection required.

 

Why MI Paste PLUS with fluoride vs Prevident booster?

MI Paste with RECALDENT™ (CPP-ACP) combined with a low dose fluoride applied regularly aids for thorough remineralization. Thorough remineralization extends to the depth of the enamel rod, versus superficial remineralization which may extend partially in depth. 

O

Is one application of MI Paste beneficial?

Yes, particularly after and/or with a professional fluoride application because MI Paste with RECALDENT™ (CPP-ACP) promotes the uptake of fluoride ion by tooth enamel. MI Paste may also be used for a patient who has a sensitivity problem. MI Paste could be used as a single application for a patient who had cervical dentinal hypersensitivity where most of the issues of lifestyle were comfortably addressed at that same visit. If one had concerns about compliance, then the patient could be given MI Paste to take home with them.
An orthodontic patient wants whitening however, the patient has decalcification on the anterior teeth, is it best to bleach first or use MI Paste initially?

For some white spot lesions it may be necessary to first pre-treat the lesion before application of MI Paste. This pre-treatment may involve bleaching, acid etching or microabrasion. Recent research at the Dental School at the University of Melbourne has demonstrated that pre-bleaching is an effecive pre-treatment for MI Paste application.

P

Why is there no patient instruction in the box?

How to use MI Paste/MI Paste PLUS is dependent upon why and how the dental professional recommends it application. It is a case by case situation. Ask your dental professional for clarification on frequency and method/of application.    

What About Pregnant Mothers?

There are no proven dental or general health benefits or risks from pre-natal fluoride containing products. Fluoride supplements are not indicated in pregnancy, however MI Paste PLUS can be used as a topical treatment in high
caries risk pregnant women or in situations where reflux is causing dental erosion and dentinal hypersensitivity

What is the pH of MI Paste

The pH of MI Paste is 7.8. it is considered a neutral pH based on a range of 0 – 14 scale. 11/13/2008

What purpose is the phosphoric acid serving?
How much is in there and will it have any effect in demineralizing enamel?

The purpose of the phosphoric acid is to buffer the CPP-ACP. MI Paste is an exceptionally good buffer of acid yet we still need the formulation to be relatively neutral to be able to get the most effective levels of remineralization. The final pH of MI Paste is around 7.8 (slightly alkaline), without the phosphoric acid it would be higher (more alkaline) which is helpful for buffering an acidic mouth but not as effective for the remineralization process.

Phosphoric acid is used to adjust the pH of MI Paste to get it close to neutral instead of alkaline (basic).

The percentage composition of phosphoric acid is < 00.3% (ie less than .3 of one percent) so it is very small. You can imagine it is more added as a formulation “tweak” to ensure the optimum performance (phosphoric acid is a recognized food additive and antioxidant) balancing between buffering and remineralization benefits. There is absolutely zero chance/potential for demineralization.

Is MI Paste safe to use while pregnant?

Regular use of MI Paste during pregnancy helps to maintain elevated levels of calcium and phosphate in the saliva, protecting the teeth from dental erosion. There is also an additional benefit because MI Paste will inhibit the growth and adhesion of mutans streptococci, which would otherwise flourish in an acidic oral environment. Any MI Paste material that is swallowed is completely safe, and will contribute towards dietary calcium.

Is MI Paste available by prescription or is only distributed through dental offices?

MI Paste is only available through the dental profession. It is available through the dental office, it is not a prescription item.   

What is pH? 

pH is the measurement of the hydrogen ion concentration, [H+]. This value ranges from 0 to 14 pH. Values below 7 pH exhibit acidic properties. Values above 7 pH exhibit basic (also known as caustic or alkaline) properties. Since 7 pH is the center of the measurement scale, it is neither acidic nor basic and is, therefore, called "neutral."

One way to measure pH is by indicators, materials that are specifically designed to change color when exposed to different pH
values. The color of a wetted sample paper is matched to a color on a color chart to infer a pH value. pH paper is available for narrow pH ranges (for example, 3.0 to 5.5 pH, 4.5 to 7.5 pH and 6.0 to 8.0 pH), and fairly wide pH ranges of 1.0 to 11.0 pH.

 

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What is the active ingredient in MI Paste? 

The active ingredient in MI Paste, RECALDENT™ (CPP-ACP) is milk derived. RECALDENT™ (CPP-ACP) is a complex of casein phosphopeptides (CPP) and amorphous calcium phosphate (ACP). Calcium phosphate is highly insoluble, however the peptides are able to maintain the calcium and phosphate in an ionic form, preventing the formation of insoluble calcium phosphate and therefore enabling calcium and phosphate ions to enter the tooth matrix and remineralize areas of hypomineralized enamel. Furthermore, the peptides bind to the surface of the tooth, and to the bacteria surrounding the tooth, presenting a reservoir of ionic calcium and phosphate at the tooth surface.

Root Surface caries and MI Paste

In patients with a high rate of root surface caries, a twice daily application of MI Paste helps to address the underlying problem of poor salivary parameters and prevent caries from effecting the remaining structure of the teeth. MI Paste is essential for long-term stability of the exposed root surfaces. Home care would include the application of MI Paste twice daily at a minimum. 

It is critical to sustain the bio-available calcium ion level within the saliva, to remineralize the tooth structure including root surfaces. The pH of saliva relates strongly to the calcium concentration of the saliva and the plaque fluid. To maintain a high level of calcium in the plaque fluid, apply MI Paste morning and evening, immediately before retiring. The MI Paste PLUS releases calcium, phosphate and fluoride for optimal remineralization of the tooth structure including root surfaces.

MI Paste is a valuable armamentarium for patients with exposed root surfaces and caries. Your patient will benefit using MI Paste.

Radiation Treatment for cancer patient? 

A patient with throat cancer who has been using MI Paste. The Radiation / Oncology Department is questioning the use of MI Paste due to the Titanium and Zinc Oxides. Will this cause "Radiation Scatter" and allow radiation to scatter to areas not aimed or patterned for radiation. Much like what deodorant does with Mammography’s and/or X-Rays.

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Would MI Paste be beneficial to patients with Sjogren's syndrome?

The combination of a reduced salivary flow and ocular dryness may indicate Sjogren's syndrome. A patient with Sjogren's syndrome would benefit from MI Paste PLUS. The suggested home care program would include MI Paste twice daily. Others aids include a saliva substitute, for comfort, (GC Dry Mouth Gel by GC America) and intermittent chlorhexidine therapy and/or fluoride treatment to suppress harmful bacterial. Always check with your dental professional.

Are there any SALICYLATES in MI Paste?
Are there any natural or artificial salicylates in any of the flavorings, CPP-ACP, CMC-Na and Xylitol.

Salicylates are a naturally occurring group of chemicals found in a wide range of foods, herbs and spices. Salicylates are similar in structure to salicylic acid which is manufactured to produce aspirin. Some people may be sensitive or allergic to aspirin and also react to foods containing salicylates.

Fruit containing salicylates include: Apricot, avocado, blackberry, black currant, blueberry, boysenberry, cherry, cranberry, currant (dried), date, grape, grapefruit, guava, Jonathan apple, kiwi fruit, lychee, mandarin, mulberry, nectarine, orange, passionfruit, peach, pineapple, plum, prune, raisin (dried), raspberry, red currant, rockmelon, strawberry, sultana (dried), watermelon etc. Food intolerance is a general term used to describe an adverse reaction to certain types of foods. Intolerance to salicylates is a relatively common condition which can be managed by avoiding foods which contain these substances. The main food sources of salicylates are fruits, vegetables, dried spices, tea and food flavorings. The average 'Western diet' has an estimated salicylate intake ranging from 10 to 200 mg per day.

• MI Paste is GRAS (generally regarded as safe)
• Salicylate is not added and not listed
• Flavor is the concern. Although salicylate is not listed on the flavors we are using, reviews on the public domains (http://www.webmd.com/allergies/guide/salicylate-allergy) indicate that salicylate is found in many flavors. Unfortunately, flavor receipts are manufactures trade secret, and GC does not have the compound profile of the flavors.
• As we do not have a specific QA assay for salicylates in MI Paste, we are not in a position to state the product is salicylate-free, or its level is safe to a specific patient. 

Sensitivity during the prophylaxis and the benefits of applying MI Paste

Today I had one of my super sensitive Perio patients in that I numb with topical and hand scale only. Instead today I polished first with MI Paste. I usually have the patient rinse but since this patient was hypersensitive, I kept the paste on and scaled. When I got to the deeper pockets I put some paste on the tip of the scaler to help desensitize subgingivally (just like I do with the topical.) For the first time ever the patient said she had NO DISCOMFORT during the cleaning!!!! I'm so excited, yet another way to use that awesome MI Paste PLUS. It works like a charm.
 
-Michelle in VA

 

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What time of day is best to use MI Paste?

In terms of the binding properties of MI Paste, CPP-ACP binds to oral soft tissues, to dental pellicle and also to plaque. This binding elevates the salivary levels of calcium and phosphate for extended periods. For this reason, MI Paste works best in patients when it is applied at night before bed, since the salivary clearance rate is low during sleep. In patients who need intensive treatment, then a twice daily application is sufficient in most individuals. It is recommended that MI Paste be applied immediately after flossing and brushing with a 1000 ppm fluoride toothpaste, particularly at night before bed.

RECALDENT™ CPP-ACP, the active ingredient of MI Paste, is extremely effective for desensitizing, and this is due to the combination of surface effects and its ability to remineralize hard tissues.

Some patients who have generalized cervical dentinal hypersensitivity, may also have dental erosion, and thus one needs to look carefully at their lifestyle (using particularly the resting salivary parameters) to gain insight into whether they have sub-clinical dehydration.

Why would I choose to use custom trays to administer MI Paste, when I can apply MI Paste with a clean finger and let the MI Paste sit for 3-5 minutes?

You can apply MI Paste with either a custom tray or with a clean finger. One method is not better than another. Check with your dental professional to determine what method of delivery would work best for you.   

What is the purpose of adding Titanium Dioxide to MI Paste? 

Titanium dioxide is used to give the white opaque look to MI Paste.   

Titanium Dioxide is found in various cosmetic and dental products as well as MI Paste. It is widely used as a food additive and as a pigment in icings for baked goods, in tobacco wrappings and tobacco substitutes, in sugar syrup coatings for products sold in tablet form, and to whiten and aged cheese.

In health products, Titanium Dioxide is used in sunscreens, as a dusting powder, and in ointments and lotions. Titanium Dioxide is also used as a pigment in paints, varnishes, enamels, and lacquers to impart whiteness, opacity, and brightness; and in paper coatings and fillers to improve opacity and brightness.

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I have a patient who is a vegan, is the calcium and phosphate in MI Paste derived from an animal source?

RECALDENT™ (CPP-ACP) is derived from the milk protein from cows.  

Does MI Paste PLUS contain any ingredients that could be harmful to porcelain veneers or their bond to tooth structure?

MI Paste PLUS does not contain any ingredients that will have a negative effect on porcelain veneers or bonding. We have not received any complaints that porcelain does not bond to tooth surfaces for patients who uses MI Paste PLUS. Of course, it should not be used in the middle of bonding procedure.

How does MI Paste PLUS compare to Fluoride rinse or varnish?

Fluoride rinses contain between 200 and 900ppm fluoride, while varnishes contain between 22,600 and 25,000ppm fluoride. These can be effective preventive agents in patients with enhanced risk, but normal salivary function.

CPP-ACPF has been shown to be superior to fluoride alone in promoting fluoride uptake into plaque and enamel in people with normal salivary function. Further CPP-ACPF promotes the remineralization of subsurface enamel with fluorapatite in the body of the lesion not just at the surface layer like fluoride alone. Patients with salivary dysfunction (dry mouth) show a great propensity to mineral loss and typically lack sufficient bioavailable calcium ions for effective remineralization when fluoride is used in isolation. Using a product such as MI Paste PLUS which releases bio-available calcium as well as phosphate and fluoride ions can help to provide effective remineralization even in more challenging situations where salivary parameters are abnormally low. It boosts salivary levels of these ions in a form equally well suited to in-office professional and at-home use.

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Can MI Paste reverse white spot lesions?

MI Paste provides the minerals (calcium and phosphate) to rebuild subsurface areas of defects in enamel, including white spot lesions from dental caries, white spot lesions associated with orthodontic treatment and fluorosis. In these defects, there are subsurface voids which can be very effectively remineralized by applying MI Paste, and this has been shown using optical and also radiographic tests at the University of Melbourne. For some white spot lesions it may be necessary to first pre-treat the lesion before application of MI Paste. This pre-treatment may involve bleaching, acid etching or microabrasion. Recent research at the Dental School at the University of Melbourne has demonstrated that pre-bleaching is an effective pre-treatment for MI Paste application.

In order to avoid the incidence of white spots, it is recommended to apply MI Paste twice daily for the entire period that brackets are in place. Immediately after the brackets are removed apply MI Paste twice daily for one month than re-evaluation the case. How fast MI Paste works will depend on the individual situation and the clinical use for which MI Paste has been chosen. 

What does W/W mean on the MI Paste PLUS packaging? 

w/w is an abbreviation for "by weight," used in chemistry and pharmacology to describe the concentration of a substance in a mixture or solution. Properly speaking, 2% w/w means that the mass of the substance is 2% of the total mass of the solution or mixture. The metric symbol g/g has the same meaning as w/w.

W/W stands for weight per weight. When we prepared a tube for Tooth Mousse PLUS prior to the launch in Australia, we checked the labelling of fluoride contained toothpaste available from Colgate. They stated like "Active ingredients: Sodium Fluoride 0.22% W/W". We also checked the OTC drug labelling guideline by FDA and found that they recommended to put both of percentage and ppm on the package, as ppm might be confusing for the end-users. Therefore we finally decided to put the amount both in ppm and percentage.

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What is the amount of xylitol in MI Paste? How much MI Paste would it take to reach the therapeutic level for xylitol?

MI Paste and MI Paste PLUS both contain 2% Xylitol

Studies have shown that a therapeutic dose to reduce dental caries is 6-10 grams per day, distributed over 3-5 time periods. Most pieces of xylitol gum have about 1.5 grams each. Many products contain less than therapeutic amounts of xylitol, often in combination with other sweeteners.

It is desirable to minimize patients' high frequency consumption of fermentable dietary substrates, including those in foods, drinks, and medications. Nonfermentable dietary sweeteners are recommended wherever possible, such as xylitol, sorbitol, aspartame, or saccharin. The polyols such as xylitol are anticariogenic, as they result in decreased acid fermentation by S. Mutans. 

 

Why does the IFU specify Vanilla for Xerostomia?

Vanilla has the most neutral taste which we found with field evaluation and was preferred by xerostomia sufferers. In severe cases of xerostomia strong flavoring may be an irritant to already sensitive oral tissues and vanilla appears to be the least irritating.