Is Hydroxyapatite FDA Authorized? – Ask the Dentist

A standard query I get is whether or not hydroxyapatite is FDA authorized. 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, usually utilized in dental workplaces, have garnered FDA approval as Class II Medical Units.

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

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

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

Hydroxyapatite is FDA authorized for medical purposes, however not but dental. In america, the Meals and Drug Administration (FDA) doesn’t enable 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 authorized labeling. FDA approval will not be 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 purposes.

Many medicines are at present prescribed and administered for off-label use, and lots of medication utilized in medical follow for youngsters have by no means been examined in youngsters. The FDA regulation states: “Good medical follow and the very best pursuits of the affected person require that physicians use legally obtainable medication, biologics and units in response to their finest information and judgment. If physicians use a product for a sign not within the authorized labeling, they’ve the accountability 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)

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

The FDA at present regulates toothpaste as a beauty product, which I consider is inadequate for a product that instantly 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 together with your sufferers, pals, or household. 

1. Does it work on enamel?

Peer reviewed research are the gold commonplace, 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 will not be suspected to be an environmental toxin, not anticipated to be probably poisonous or dangerous, and never suspected to be bioaccumulative (Supply).

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

In dentistry, now we have a nasty behavior of specializing in simply the enamel and neglecting the influence of medicine and medicines on systemic well being. 

This is the reason 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 planet that meets the rigorous requirements offered by the SCCS last opinion on March 2023 is Fluidinova, made in Portugal, and this is without doubt one of the causes we selected Fluidnova because the supply of hydroxyapatite for all of our toothpastes and varnishes at Fygg.

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

The SCCS concludes the next:

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

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 at the least 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 are usually not coated or floor modified.

Will the FDA approve hydroxyapatite in the future?

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

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

D2991 Utility of hydroxyapatite regeneration medicament – per tooth 

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

2. The charges for D2991, on the identical tooth and on the identical date of service as a restoration, are usually not billable to the affected person on the identical 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 shall be acknowledged quickly.

Within the meantime, what are you able to do?

Whether or not you’re a affected person or a practitioner, if you’re obsessed with this subject, I encourage you to write down 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 should you select:

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

Staci Whitman:

Topic: Request for Protection of Hydroxyapatite Varnish

Expensive {{NAME}},

I’m writing to you at this time to advocate for the inclusion of hydroxyapatite varnish as a coated profit on your dental insurance coverage. As a pediatric dentist with practically twenty years of medical expertise, I’ve witnessed firsthand the transformative influence of this materials on youngsters’s oral well being.

Hydroxyapatite varnish gives a protected and efficient, minimally invasive method to arresting and remineralizing early cavitations. Not like conventional fillings, which require native anesthetic and drilling, and sometimes sedation and common 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 in addition 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 youngsters. This interprets to fewer anesthesia visits, lowered therapy time, and finally, a decrease general value for each sufferers and insurance coverage suppliers. Moreover, by arresting the development of cavities early, we will forestall the necessity for extra in depth and costly restorative procedures down the road.  Hydroxyapatite has additionally been proven to assist modulate and optimize the oral microbiome, one thing fluoride can’t do. 

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

• Diminished Variety of Fillings: Since incorporating hydroxyapatite varnish into my follow, I’ve seen a [Percentage] lower within the variety of fillings positioned on youngsters.
• Fewer Anesthesia Visits: The painless utility of varnish eliminates the necessity for anesthesia in lots of circumstances, lowering nervousness 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 beneficial software for caries prevention. By together with protection for code D2991, Delta Dental could be demonstrating a dedication to proactive oral healthcare for youngsters, finally resulting in a more healthy and more cost effective method to pediatric dentistry.

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

Thanks on your time and consideration. I might be glad to offer any additional info, analysis, or reply any questions you might have.

Sincerely,

Anastacia M Whitman, DMD, IFMCP

Board-Licensed Pediatric Dentist