Dental practices across the nation are just one category of small businesses that have suffered, both economically and logistically, due to the near-national shutdown in response to the COVID-19 pandemic. And as lawmakers are working on the next relief package, the American Dental Association, on behalf of its 163,000 members, is urging Congress to include language to assist the dental industry in the process of recovery.

The ADA is making a few key recommendations to legislators:

1. Increase flexibility within the Paycheck Protection Program. ADA representatives are asking that the loan forgiveness guidelines allow individual small businesses to make their own decisions regarding payroll and staffing based on individual plans to reopen.

Dentists would like to see Paycheck Protection Program (PPP) loan funds allowed for purchasing additional personal protective equipment (PPE), making safety improvements to offices, and qualifying for tax credit.

2. Allow nonprofit dental and medical organizations to have access to the Paycheck Protection Program or future small business loan programs.

3. Execute better oversight for the distribution and loan forgiveness process in the Coronavirus Aid, Relief, and Economic Security (CARES) Act for PPP loans to guarantee that only those small businesses that were economically distressed as a result of the pandemic receive the funds and forgiveness.

4. Ramp up the production of PPE with more focused distribution to healthcare workers, including dentists.

5. And a big one:Extend the Department of Health and Human Services’ authority to allow licensed dentists to conduct FDA-authorized COVID-19 diagnostic tests until the end of the year.

This last recommendation is an important one as it would help alleviate the burden of hospital emergency rooms across the country who are coping with the pandemic.

Dentists can visit the Legislative Action Center to contact their legislators today regarding these recommendations. For the latest information on COVID-19, visit ADA.org/virus.

Sealants prevent cavities in kids. Science says so.

So why is the Health Resources and Services Administration (HRSA) proposing a watered-down measure, titled “Primary Caries Prevention Intervention as Offered by Primary Care Providers, Including Dentists,” that would take the place of current recommendations on sealants for kids?

That’s what the American Dental Association (ADA) and the American Academy of Pediatric Dentistry (AAPD) would like to know!

Leaders from both organizations sent a letter Aug. 27 to the HRSA in response to a proposed change to the current sealant measures.

“We are writing to express our concerns about the proposed replacement of the Dental Sealants for Children Between 6-9 Years measure,” ADA President Jeffrey M. Cole, ADA Executive Director Kathleen T. O’Loughlin, AAPD President Kevin Donly and AAPD Chief Executive Officer John S. Rutkauskas wrote in the letter. “Research has shown that sealants are effective in preventing occlusal carious lesions in the molars of children when compared with controls without sealants.”

The letter points to an evidence-based clinical practice guideline released in 2016 by the ADA and AAPD that found sealants could minimize the progression of cavities in permanent molars in children and adolescents compared with the nonuse of sealants or use of fluoride varnishes.

“There is in fact evidence to suggest the superiority of resin-based fissure sealants over fluoride varnishes applied to prevent decay in permanent molars,” the letter stated. “While both topical fluoride, as well as dental sealants, are important caries preventive modalities, we fail to see the agency’s rationale for removing the focus on improving sealant rates, especially given the improvement health centers have made.”

As reported by 1,362 administration-funded health centers, their performance improved more than 10% between 2015 –– when the sealant measure was first adopted –– and 2018.

Nearly 53% of children 6 to 9 years old who are at an elevated risk for caries received the recommended sealants. Thirty-six states also have performed better by at least 5% on the measure from 2015 to 2017.

The HRSA explained its rationale in a letter to health centers, stating the fluoride varnish measure would increase the target population from high-risk children who are 6 to 9 years old to children and adolescents as old as 20 and include oral health preventative measures that health centers without dentists can employ.

“The application of fluoride varnish to the teeth of children reduces the risk of development of caries,” the administration stated. “Increasing the use of non-dental providers (i.e., primary care providers) providing fluoride varnish to their patients can reduce the incidence of caries and promote better oral health.”

However, the fluoride varnish measure would track only one application of varnish during the measurement period, contrary to evidence-based guidelines that state topical fluoride should be applied every three to six months in children at an elevated risk for cavities.

The ADA and the AAPD are encouraging the HRSA to only consider metrics that are supported by strong scientific evidence and further tested for validity, feasibility, reliability and usability. The officials noted the sealant measure was developed and tested by the Dental Quality Alliance, an entity convened by the ADA that maintains the measure through a periodic review process to align it with emerging science and implementation experience.

“The use of measures that have not been adequately tested undermines confidence in measures among providers and consumers of health care,” the letter concluded.

Updates on this issue can be found at ada.org.

You may have seen ads for SmileDirectClub, a direct-to-consumer business model that sells plastic aligners to members for straightening teeth. At first pass, it may seem like a good idea. Straighten your teeth without so much as one visit to the orthodontist?

But not everyone is a fan.

The American Dental Association recently sent a complaint letter to the Federal Trade Commission’s Bureau of Consumer Protection, citing concerns over aspects of SmileDirectClub’s marketing and direct-to-consumer sales of plastic teeth aligners.

The letter follows a citizen’s petition filed by the ADA with the U.S. Food and Drug Administration, stating that SmileDirectClub is placing the public at risk by knowingly evading the FDA’s “by prescription only” restriction the agency has placed on teeth aligning materials.

“The ADA took these actions out of concern for patient safety and to enable consumers to take action when negative treatment outcomes occur,” said Dr. Jeffrey M. Cole, ADA president. Dr. Cole outlined practices of SmileDirectClub that the Association believes to be deceptive. These include:

• Informing purchasers they have recourse against SmileDirectClub via arbitration when, in the same document, SmileDirectClub hides a “small print” provision obligating the customer to waive any and all rights the customer “or any third party” may have against SmileDirectClub.
• Encouraging consumers to become customers by telling them individually and directly that SmileDirectClub aligners will correct their overbite, underbite and crossbite conditions or their “extreme” malocclusion. However, when customers complain, SDC invokes other SDC documents that state its aligners cannot treat bite conditions at all and can only treat mild to moderate teeth misalignment, not “extreme” misalignment.
• Claiming that SDC customers receive the same level of dental/orthodontic care as actual dental patients when actually SDC and its affiliated dentists provide virtually no care and, contrary to its claims, SDC does not use teledentistry.

In the initial citizen petition filed with the FDA, the Association states that SmileDirectClub is evading the “by prescription only” restriction that the FDA placed on plastic teeth aligners and on dental impression material.

The ADA argues that SmileDirectClub is cutting out the step of having dentists perform patient exams, meeting the applicable standard of care, as the basis of prescribing orthodontic treatment. Instead, SmileDirectClub requires customers to self-report their dental condition. The ADA argues that self-reporting doesn’t meet the standard of care because it doesn’t satisfy a dentist’s required professional due diligence.

“Moving teeth without knowing all aspects of a patient’s oral condition has the potential to cause the patient harm,” Dr. Cole said. “Orthodontic treatment, if not done properly, could lead to potential bone loss, lost teeth, receding gums, bite problems, jaw pain and other issues. The ADA considers it our duty on behalf of the public to make the relevant regulatory agencies aware of what’s going on so they can consider whatever actions they deem appropriate.

For more information about direct-to-consumer dentistry, visit the ADA’s consumer website MouthHealthy.org/DIYdentistry. And to report poor clinical outcomes associated with medical devices, consumers and health care professionals may use the FDA’s MedWatch voluntary reporting form at FDA.gov.