A typical query I get is whether or not hydroxyapatite is FDA accredited. The brief reply? No, it’s not. However let’s delve deeper into why that’s and what it means for you.

Conventional fluoride varnishes, typically utilized in dental places of work, have garnered FDA approval as Class II Medical Gadgets.

Nevertheless, it’s essential to grasp that this approval pertains to their use as cavity liners and tooth desensitizers, not as caries preventive brokers.

In actual fact, fluoride varnishes are continuously utilized “off-label” for caries prevention, a follow permitted by the FDA.

Why isn’t hydroxyapatite FDA accredited for dental use but?

Hydroxyapatite is FDA accredited for medical functions, however not but dental. In the USA, the Meals and Drug Administration (FDA) doesn’t permit cavity-fighting claims for toothpastes that don’t have fluoride.

The reality is, many oral care elements, together with fluoride (sure, fluoride!), lack FDA approval for sure makes use of, and we use them off-label. This doesn’t imply fluoride or hydroxyapatite don’t work—as a substitute, it highlights the evolving panorama of oral well being analysis and regulation.

The FDA’s stance on off-label use underscores the significance of knowledgeable decision-making and accountable utilization by healthcare professionals. Practitioners are inspired to depend on scientific rationale and medical proof when using merchandise for functions past their accredited labeling. FDA approval is just not required to make use of fluoride varnish off-label. (USFDA, 1998, USP DI, 2006) 

In abstract, the absence of FDA approval for hydroxyapatite doesn’t diminish its effectiveness or security. As a substitute, it underscores the necessity for a nuanced understanding of oral care elements and their functions.

Many medicines are at the moment prescribed and administered for off-label use, and plenty of medication utilized in medical follow for youngsters have by no means been examined in kids. The FDA regulation states: “Good medical follow and the most effective pursuits of the affected person require that physicians use legally obtainable medication, biologics and gadgets in accordance with their greatest information and judgment. If physicians use a product for a sign not within the accredited labeling, they’ve the duty to be well-informed in regards to the product, to base its use on agency scientific rationale and on sound medical proof, and to keep up data of the product’s use and results.” (USFDA, 1998; AAP, 2002)

Get Dr. B’s Dental Well being Ideas

Free weekly dental well being recommendation in your inbox, plus 10 Insider Secrets and techniques to Dental Care as a free obtain while you enroll

So, within the absence of FDA-approval, what must you search for in a hydroxyapatite toothpaste?

The FDA at the moment regulates toothpaste as a beauty product, which I imagine is inadequate for a product that straight impacts the oral microbiome and whole-body systemic well being. To not point out, it’s used twice a day for all times. 

Within the absence of regulation, these are the standard requirements that I’ve provide you with to establish shopper efficacy, well being, and security, and I encourage you to share these broadly along with your sufferers, buddies, or household. 

1. Does it work on enamel?

Peer reviewed research are the gold normal, as we all know. A number of peer-reviewed research have demonstrated the efficacy of hydroxyapatite for caries, sensitivity, and even whitening. 

The Environmental Working Group has given hydroxyapatite a 1/10, discovering that hydroxyapatite is just not suspected to be an environmental toxin, not anticipated to be doubtlessly poisonous or dangerous, and never suspected to be bioaccumulative (Supply).

2. Is it protected for the remainder of the physique?

In dentistry, we’ve a nasty behavior of specializing in simply the enamel and neglecting the influence of medication and medicines on systemic well being. 

That is why I look to the SCCS ruling, because the SCCS is like an FDA however with stricter requirements, they usually have assessed hydroxyapatite’s influence on systemic well being. As of this writing, the one hydroxyapatite on the earth that meets the rigorous requirements offered by the SCCS last opinion on March 2023 is Fluidinova, made in Portugal, and this is likely one of the causes we selected Fluidnova because the supply of hydroxyapatite for all of our toothpastes and varnishes at Fygg.

From the SCCS Remaining Opinion on nano-Hydroxyapatite, March 2023, web page 3:

The SCCS concludes the next:

1. In view of the above, and taking into consideration the scientific knowledge offered, does the SCCS take into account hydroxyapatite (nano) protected when utilized in oral beauty merchandise in accordance with the utmost concentrations and specs as reported within the submission, taking into consideration moderately foreseeable publicity circumstances?

Based mostly on the info offered, the SCCS considers hydroxyapatite (nano) protected when used at concentrations as much as 10% in toothpaste, and as much as 0.465% in mouthwash.

This security analysis solely applies to the hydroxyapatite (nano) with the next traits: 

– composed of rod-shaped particles of which not less than 95.8% (in particle quantity) have a facet ratio lower than 3, and the remaining 4.2% have a facet ratio not exceeding 4.9; 

– the particles usually are not coated or floor modified.

Will the FDA approve hydroxyapatite at some point?

Although hydroxyapatite toothpaste and polish usually are not FDA-approved, there’s constructive motion ahead:

In 2024, the CDT adopted new codes for the usage of hydroxyapatite varnishes:

D2991 Software of hydroxyapatite regeneration medicament – per tooth 

1. When coated, process D2991 is a profit twice per tooth per profit 12 months. Advantages for greater than twice per tooth per profit 12 months are denied and are the affected person’s duty. 

2. The charges for D2991, on the identical tooth and on the identical date of service as a restoration, usually are not billable to the affected person on the similar dentist/dental workplace.

Actions into new supplies and procedures take time. We noticed this with the motion away from alloy fillings and with the implementation of SDF, and we’re assured hydroxyapatite will likely be acknowledged quickly.

Within the meantime, what are you able to do?

Whether or not you’re a affected person or a practitioner, in case you are obsessed with this matter, I encourage you to put in writing letters to insurance coverage firms and the FDA. My colleague and accomplice at Fygg, Dr. Staci Whitman, shared with me a letter she’s written to the FDA, and I’ve included it beneath with permission as a template so that you can copy/paste and use your self if you happen to select:

Instance letter urging insurance coverage firms and/or FDA approval of hydroxyapatite

Staci Whitman:

Topic: Request for Protection of Hydroxyapatite Varnish

Pricey {{NAME}},

I’m writing to you as we speak to advocate for the inclusion of hydroxyapatite varnish as a coated profit in your dental insurance policy. As a pediatric dentist with almost twenty years of scientific expertise, I’ve witnessed firsthand the transformative influence of this materials on kids’s oral well being.

Hydroxyapatite varnish provides a protected and efficient, minimally invasive method to arresting and remineralizing early cavitations. In contrast to conventional fillings, which require native anesthetic and drilling, and infrequently sedation and basic anesthesia, varnish will be utilized topically throughout follow-up and routine checkups to handle illness similar to fluoride vanishes. This not solely reduces the necessity for extra invasive procedures but additionally creates a constructive dental expertise for younger sufferers, fostering a lifelong dedication to oral well being.

In my follow, the usage of hydroxyapatite varnish has resulted in a big lower within the variety of fillings and crowns I place on kids. This interprets to fewer anesthesia visits, diminished therapy time, and in the end, a decrease general price for each sufferers and insurance coverage suppliers. Moreover, by arresting the development of cavities early, we will forestall the necessity for extra intensive and costly restorative procedures down the road.  Hydroxyapatite has additionally been proven to assist modulate and optimize the oral microbiome, one thing fluoride can not do. 

Right here’s a breakdown of the constructive influence I’ve noticed:

• Lowered Variety of Fillings: Since incorporating hydroxyapatite varnish into my follow, I’ve seen a [Percentage] lower within the variety of fillings positioned on kids.
• Fewer Anesthesia Visits: The painless utility of varnish eliminates the necessity for anesthesia in lots of instances, decreasing anxiousness and making a extra constructive dental expertise for younger sufferers.
• Early Intervention: Varnish permits for early intervention, stopping the development of cavities earlier than they require extra invasive procedures.

The American Academy of Pediatric Dentistry (AAPD) acknowledges hydroxyapatite varnish as a invaluable instrument for caries prevention. By together with protection for code D2991, Delta Dental can be demonstrating a dedication to proactive oral healthcare for youngsters, in the end resulting in a more healthy and less expensive method to pediatric dentistry.

I urge you to strongly take into account including hydroxyapatite varnish to your listing of coated advantages. I’m assured that this choice would have a big constructive influence on the oral well being of your pediatric sufferers.

Thanks in your time and consideration. I might be pleased to supply any additional info, analysis, or reply any questions you might have.

Sincerely,

Anastacia M Whitman, DMD, IFMCP

Board-Licensed Pediatric Dentist