Interview with the Developer of FluoriMax and Advantage Arrest

Recently, a member of our team, Martha Szczepulski (also RDH), met with Steve Pardue, Managing Member at Elevate Oral Care, the company behind the development of FluoriMax (2.5% Sodium Fluoride Varnish) and Advantage Arrest (Silver Diamine Fluoride).

Here is a summary of their discussion. We hope this will help you integrate these highly effective in-offices caries management treatments.

FLUORIMAX

Why is there only 2.5% NaF in FluoriMax?

Studies going back to the 1990s show that even in a colophony, the fluoride uptake (bioavailability) is very similar between 2.5 and 5% formulations. Therefore, it is best to use the lowest percentage that produces effective results. (1)

How much hydroxyapatite is in FluoriMax?

3%. It is a source of calcium and phosphate. However, at this percentage there is no real benefit to a normal mouth, and maybe a miniscule benefit to a patient with xerostomia. True benefit is from the sodium fluoride.

How long does FluoriMax remain in the oral cavity?

It remains until it is removed.

Approximately 90% of the uptake is within the first 4 hours, the next 24 hours up to 10%.

This is safe due to the small quantities being applied. 1 drop = 0.1mL, so a generous 3 drop dose would be 0.3mL.

In a study by Dr Beltran, published in JADA in 2000, the blood plasma levels of fluoride after FluoriMax application were less than a regular toothpaste application. (2)

What is dewaxed food grade shellac?

Shellac is a natural product that is produced from a resinous secretion found on trees, made by a group of insects called Kerria lacca. The secretion, called lac, is refined into food grade shellac, amongst other shellac products.

You will have seen shellac as the shiny coating on an Advil or a Chicklet. 

Where should I apply FluoriMax?

The recommendation is to apply to the buccal surfaces in a thin layer where it acts as a reservoir. This reservoir works best as a thin layer. A thick layer is less bioavailable and is more likely to slough off and be swallowed. A thin layer is more comfortable and more bioavailable.

FluoriMax can be applied on a lesion or near a lesion – the fluoride ions will be transported via saliva into the lesion regardless.

For maximum uptake, especially in patients with xerostomia, make sure to apply to teeth in close proximity to the submandibular glands (buccal and lingual sextant 5). This saliva is more liquid and facilitates fluoride ion transportation. Near the parotid glands is also good, but this saliva is typically more ropey and does not facilitate transport as well as the more liquid saliva from the submandibular glands.

In severe xerostomia, sipping a glass of water over the hour after the application would help increase fluoride uptake – this would provide the necessary water to aid in fluoride ion transportation.

Is there a difference in the particle size of FluoriMax fluoride?

Yes. Conventional fluoride particles are in the range of 150 microns (unless the manufacturer mills them first). FluoriMax has micronized particles – the fluoride particles are milled and sifted to 15 microns and smaller. This is done for two reasons. With smaller particles there is more surface area, so therefore greater bioavailability. Secondly, smaller particles stay in suspension longer (although it is always recommended to shake the bottle before application to achieve an even distribution of particles in suspension before dispensing)

Are there any ingredients that patients could have an adverse effect to in the FluoriMax?

To our knowledge no. Some people claim a reaction to shellac, but this has not been substantiated by scientific literature.

What are high intensity treatments with FluoriMax?

These are 3 applications in 5-7 days. This has been done in outreach work in other countries to maximize mineralization in a short term exposure with no followup available.

What are tips for getting the best out of the product application and keeping the bottle clean?

Always shake the bottle 10-15 seconds – less than that and you may not get the optimal suspension and consistency. FluoriMax is runnier than conventional colophony varnish and that is a good thing because it spreads very thin and requires less product.

Always dispense with the bottle vertical. If the applicator tip gets sticky, wipe off excess with alcohol. If the dispenser is really clogged, you can remove the cap and rinse with water. If the orifice is plugged, you can open it with a pin. You can also ask for additional dispensing caps from Oral Science. 

ADVANTAGE ARREST

Should I apply FluoriMax after applying Advantage Arrest?

There are two ways to apply Advantage Arrest. You can apply and allow to air dry for 60 sec. Or you can apply and immediately place a layer of FluoriMax over the AA to seal it in and allow for maximum penetration. The second measure is best to use in situations of low patient compliance. It will also make the aftertaste less metallic. 

It is unknown if it is superior to apply FluoriMax over Advantage Arrest but it may improve arrest rate.

Is Advantage Arrest safe for soft tissues (subg and class V applications)?

Advantage Arrest has a pH of 10 which means it is not caustic to sound soft tissues. It will dry and blanche tissue temporarily, but this is not harmful or painful. 

Advantage Arrest will cause irritation in wounded tissue. It is not harmful but can be sensitive. Application of Advantage Arrest is not recommended in a case of ulcerative gingivitis if the application would touch soft tissue.

What about placing Advantage Arrest in deep lesions?

Advantage Arrest will penetrate 2-2.5mm into tooth structure – penetration varies in each tooth and lesion.

Advantage Arrest can be applied in all carious lesions up to and including indirect pulp capping. Direct pulp cap is contraindicated. If there is no evidence of pulpal involvement or exposure (such as drainage or fistulas), Advantage Arrest can be applied. When it is placed near pulp, it will encourage pulp to shrink. Silver can go into the pulp in indirect pulp cap, but this is not detrimental to the pulp or tooth. 

What happens when I use Advantage Arrest then immediately place a glass ionomer restorative cement?

If you apply Advantage Arrest and want to do an immediate GI placement:

Apply it as normal, then rinse and dry (do not dessicate). You can place the GI but some silver will be drawn into the GI, so staining of the GI will occur. This is only an esthetic concern. It does not decrease the bond strength. For maximum bond strength, a polyacrylic acid may be applied either before or after the Advantage Arrest (then rinse and dry, do not dessicate) for maximum bond strength. If using polyacrylic acid step, you may notice a slight foam on application of the acid and this is normal.

How to avoid GI staining with direct placement of GI (no tooth structure polish or removal)?

To avoid staining, it is a two-appointment process. On first day, apply Advantage Arrest as normal. After 24-72 hours (longer is better), place the GI restorative as usual. This technique is called the 2 day SMART (Silver Modified Atraumatic Resin Technique).

How to avoid staining with light cure products?

Please note: Light curing will “activate” stain of all Advantage Arrest, whether it is on sound or decayed tooth structure. Helpful techniques to avoid staining are:

After placement of Advantage Arrest, do a 2-3 second light cure to observe if Advantage Arrest has stained an esthetic area, then polish that away. Then you can proceed with restoration. A few additional things to consider:

• An opaque GI or resin base can be used at the base of the restoration to mask grey tooth structure. Translucent composite could show more grey through it. 
• In bonding systems called “Self etch” where the etch, prime and bond are in one bottle, the bond is weaker than in non self etch systems. There is still bond strength but you may not want to use this in high compression areas, etc.

How frequently should Advantage Arrest be applied?

Consider your patient habits and assess the hardness of the lesion.

Patients with poor oral hygiene and high intake of cariogenic foods may need indefinite reapplication of Advantage Arrest every 3-6 months.

Patients with good oral hygiene and low to moderate intake of cariogenic foods should have at least two applications. Then reassess the lesion and consider applying every 6 months or annually to maintain arrest.

How much of the lesion is arrested with the application?

The first application can arrest 70-75% of the lesion. The second application can arrest 90-95% of the lesion. (2016 study)

Do you need to rinse or not rinse after Advantage Arrest placement?

Either is fine. If no rinse, you may want to blot site after placement to absorb excess SDF (to minimize taste)

“I heard RivaStar doesn’t stain. Why should I use Advantage Arrest?”

Facts about RivaStar vs Advantage Arrest:

RivaStar has a pH of 13 – it is caustic to soft tissues and should not touch soft tissue. AA has a pH of 10, which is not caustic. It may temporarily dry and blanche tissue but it is not harmful to the tissue. 

RivaStar cost per application is 2-3 times that of Advantage Arrest. 

RivaStar is marketed to be used under GI class I restorations. In this application, it will not stain because it is essentially sealed in and the product was just placed on the floor of the restoration. However, if SDF and KI are used alone, or the margins of the restoration contain SDF and KI, the KI will reduce and slow down the staining, but it does not inhibit the staining. The staining will likely show up within a month. 

Lastly, when SDF stands alone, it is a very effective caries inhibition agent. When SDF and KI are combined, there is an almost half decrease in efficiency. Caries inhibition is significantly less in the presence of SDF and KI combined. (3)

My conclusion

FluoriMax provides the same protection as a conventional varnish, but with several major advantages: Increased bioavailability, which means lower percentage of fluoride is required. The application is easy, product is thin and pleasant, and patients can eat and drink right away. Patients that have previously said "no" to varnish love FluoriMax.

Advantage Arrest is a minimally invasive intervention that is widely used in pediatric and geriatric care. While it is important to tell patients and caregivers about the lesion changing color, I find patient acceptance is high.  Many caregivers of vulnerable patients and people with financial barriers are relieved when they are given an affordable, non-invasive option that will arrest decay.

For dental hygienists that are placing GIs, most restorations with SDF plus KI will inevitably turn dark, at least around the edges. Using SDF with KI alone will turn dark over time, and the caries arrest properties are significantly reduced in the presence of KI. And lastly, any lesions that are subg or at the gingival margin cannot be sufficiently isolated for soft tissue protection. You may need to charge more for SDF and KI to recover product cost. 

References

1. Seppä L, Effects of sodium fluoride concentrations on enamel remineralization in vitro. Scand J Dent Res 1988;96:304-309.

2. Beltrán-Aguilar ED, Goldstein JW, Lockwood SA. Fluoride varnishes. A review of their clinical use, cariostatic mechanism, efficacy and safety. J Am Dent Assoc. 2000 May;131(5):589-96. doi: 10.14219/jada.archive.2000.0232. PMID: 10832252.

3. Zhao IS, Mei ML, Burrow MF, Lo EC, Chu CH. Effect of Silver Diamine Fluoride and Potassium Iodide Treatment on Secondary Caries Prevention and Tooth Discolouration in Cervical Glass Ionomer Cement Restoration. Int J Mol Sci. 2017 Feb 6;18(2):340. doi: 10.3390/ijms18020340. PMID: 28178188; PMCID: PMC5343875.