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Thursday, May 30, 2024

Is Hydroxyapatite FDA Permitted? – Ask the Dentist


A typical query I get is whether or not hydroxyapatite is FDA permitted. 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, usually utilized in dental workplaces, 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.

Actually, fluoride varnishes are often utilized “off-label” for caries prevention, a apply 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 permit cavity-fighting claims for toothpastes that don’t have fluoride.

The reality is, many oral care substances, 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 just 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 substances and their functions.

Many drugs are at present prescribed and administered for off-label use, and lots of medication utilized in medical apply for youngsters have by no means been examined in kids. The FDA regulation states: “Good medical apply and the very best pursuits of the affected person require that physicians use legally out there medication, biologics and units in response to their greatest data and judgment. If physicians use a product for a sign not within the permitted 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)

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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 imagine 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 give you to determine shopper efficacy, well being, and security, and I encourage you to share these broadly together with your sufferers, associates, 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 just isn’t 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/substances/703046-HYDROXYAPATITE/ 

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 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 supplied 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 considering the scientific information supplied, does the SCCS contemplate hydroxyapatite (nano) protected when utilized in oral beauty merchandise in response to the utmost concentrations and specs as reported within the submission, considering fairly foreseeable publicity circumstances?

Primarily based on the information supplied, 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 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 aren’t coated or floor modified.

Will the FDA approve hydroxyapatite someday?

Although hydroxyapatite toothpaste and polish aren’t FDA-approved, there may be constructive motion ahead:

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

D2991 Software 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, aren’t 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 matter, I encourage you to jot down letters to insurance coverage corporations and the FDA. My colleague and companion at Fygg, Dr. Staci Whitman, shared with me a letter she’s written to the FDA, and I’ve included it under 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 corporations and/or FDA approval of hydroxyapatite

Staci Whitman:

Topic: Request for Protection of Hydroxyapatite Varnish

Pricey {{NAME}},

I’m writing to you at present 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 affect of this materials on kids’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 infrequently sedation and basic anesthesia, varnish may 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 additionally creates a constructive dental expertise for younger sufferers, fostering a lifelong dedication to oral well being.

In my apply, using hydroxyapatite varnish has resulted in a major lower within the variety of fillings and crowns I place on kids. This interprets to fewer anesthesia visits, diminished 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 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 constructive affect I’ve noticed:

  • Decreased Variety of Fillings: Since incorporating hydroxyapatite varnish into my apply, 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 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 helpful software for caries prevention. By together with protection for code D2991, Delta Dental can be demonstrating a dedication to proactive oral healthcare for youngsters, finally resulting in a more healthy and less expensive method to pediatric dentistry.

I urge you to strongly contemplate including hydroxyapatite varnish to your record of coated advantages. I’m assured that this resolution would have a major constructive affect on the oral well being of your pediatric sufferers.

Thanks in your time and consideration. I’d be blissful to supply any additional data, analysis, or reply any questions you could have.

Sincerely,

Anastacia M Whitman, DMD, IFMCP

Board-Licensed Pediatric Dentist

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