Is Hydroxyapatite FDA Accredited? – Ask the Dentist

A standard query I get is whether or not hydroxyapatite is FDA authorized. The quick 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 Units.

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 regularly utilized “off-label” for caries prevention, a observe 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 the USA, 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 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 kids. The FDA regulation states: “Good medical observe and one of the best pursuits of the affected person require that physicians use legally out there medication, biologics and gadgets in accordance with their greatest data 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 take care of information of the product’s use and results.” (USFDA, 1998; AAP, 2002)

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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 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 tooth?

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 doubtlessly poisonous or dangerous, and never suspected to be bioaccumulative: https://www.ewg.org/skindeep/elements/703046-HYDROXYAPATITE/ 

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

In dentistry, we now have a nasty behavior of specializing in simply the tooth and neglecting the affect of medication and drugs on systemic well being. 

That is why I look to the SCCS ruling, because the SCCS is like an FDA however with stricter requirements, and so they have assessed hydroxyapatite’s affect on systemic well being. As of this writing, the one hydroxyapatite on this planet that meets the rigorous requirements offered by the SCCS ultimate 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 Remaining Opinion on nano-Hydroxyapatite, March 2023, web page 3:

The SCCS concludes the next:

1. In view of the above, and considering the scientific information offered, does the SCCS think about hydroxyapatite (nano) secure when utilized in oral beauty merchandise in accordance with the utmost concentrations and specs as reported within the submission, considering fairly foreseeable publicity circumstances?

Based mostly on the information offered, 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 side ratio lower than 3, and the remaining 4.2% have a side 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’s constructive motion ahead:

In 2024, the CDT adopted new codes for using 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 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, if you’re enthusiastic about this subject, 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 in the event you 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 in the present day 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 medical expertise, I’ve witnessed firsthand the transformative affect of this materials on kids’s oral well being.

Hydroxyapatite varnish affords a secure 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 basic anesthesia, varnish could be utilized topically throughout follow-up and routine checkups to handle illness identical 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 observe, using 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, lowered remedy time, and in the end, a decrease general value for each sufferers and insurance coverage suppliers. Moreover, by arresting the development of cavities early, we will 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 not do. 

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

• Decreased Variety of Fillings: Since incorporating hydroxyapatite varnish into my observe, I’ve seen a [Percentage] lower within the variety of fillings positioned on kids.
• Fewer Anesthesia Visits: The painless software 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 useful software for caries prevention. By together with protection for code D2991, Delta Dental could be demonstrating a dedication to proactive oral healthcare for youngsters, in the end resulting in a more healthy and more cost effective method to pediatric dentistry.

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

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

Sincerely,

Anastacia M Whitman, DMD, IFMCP

Board-Licensed Pediatric Dentist