Is Hydroxyapatite FDA Accredited? – Ask the Dentist

A typical query I get is whether or not hydroxyapatite is FDA permitted. 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 workplaces, have garnered FDA approval as Class II Medical Units.

Nonetheless, 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 ceaselessly utilized “off-label” for caries prevention, a observe permitted by the FDA.

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

Hydroxyapatite is FDA permitted for medical functions, 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 components, 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 permitted labeling. FDA approval isn’t 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 components and their functions.

Many drugs are presently prescribed and administered for off-label use, and plenty of medication utilized in medical observe for youngsters have by no means been examined in youngsters. The FDA regulation states: “Good medical observe and the perfect pursuits of the affected person require that physicians use legally obtainable medication, biologics and units based on their greatest information and judgment. If physicians use a product for a sign not within the permitted labeling, they’ve the duty to be well-informed concerning 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 presently regulates toothpaste as a beauty product, which I imagine is inadequate for a product that immediately 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 give you to establish client efficacy, well being, and security, and I encourage you to share these extensively together with your sufferers, mates, or household. 

1. Does it work on tooth?

Peer reviewed research are the gold customary, 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 isn’t suspected to be an environmental toxin, not anticipated to be probably poisonous or dangerous, and never suspected to be bioaccumulative: https://www.ewg.org/skindeep/components/703046-HYDROXYAPATITE/ 

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

In dentistry, we’ve got a foul behavior of specializing in simply the tooth and neglecting the impression of medicine and drugs on systemic well being. 

For this reason I look to the SCCS ruling, because the SCCS is like an FDA however with stricter requirements, they usually have assessed hydroxyapatite’s impression on systemic well being. As of this writing, the one hydroxyapatite on this planet that meets the rigorous requirements supplied by the SCCS remaining 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 Closing Opinion on nano-Hydroxyapatite, March 2023, web page 3:

The SCCS concludes the next:

1. In view of the above, and making an allowance for the scientific information supplied, does the SCCS take into account hydroxyapatite (nano) secure when utilized in oral beauty merchandise based on the utmost concentrations and specs as reported within the submission, making an allowance for fairly foreseeable publicity situations?

Primarily based on the information supplied, the SCCS considers hydroxyapatite (nano) secure 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 very 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 will not be coated or floor modified.

Will the FDA approve hydroxyapatite someday?

Despite the fact that hydroxyapatite toothpaste and polish will not be FDA-approved, there’s optimistic 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 lined, 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, will not be 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 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 captivated with this matter, I encourage you to write down letters to insurance coverage corporations 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 for those who select:

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

Staci Whitman:

Topic: Request for Protection of Hydroxyapatite Varnish

Expensive {{NAME}},

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

Hydroxyapatite varnish provides a secure 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 might 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 optimistic dental expertise for younger sufferers, fostering a lifelong dedication to oral well being.

In my observe, 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, diminished therapy time, and finally, a decrease general price for each sufferers and insurance coverage suppliers. Moreover, by arresting the development of cavities early, we are able to stop 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’t do. 

Right here’s a breakdown of the optimistic impression I’ve noticed:

• Lowered Variety of Fillings: Since incorporating hydroxyapatite varnish into my observe, I’ve seen a [Percentage] lower within the variety of fillings positioned on youngsters.
• Fewer Anesthesia Visits: The painless software of varnish eliminates the necessity for anesthesia in lots of circumstances, lowering nervousness and making a extra optimistic 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 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 listing of lined advantages. I’m assured that this resolution would have a big optimistic impression on the oral well being of your pediatric sufferers.

Thanks to your time and consideration. I’d be completely happy to supply any additional data, analysis, or reply any questions you might have.

Sincerely,

Anastacia M Whitman, DMD, IFMCP

Board-Licensed Pediatric Dentist