Tuesday, August 31, 2021

Michigan Dentist Charged for Fraud

 If true, this is a bit of a sad story, but it also has a bit of a techy slant...

A Lansing, Michigan dentist has been charged with 10 counts of defrauding Medicaid.  To be specific, the Michigan Healthy Kids Dental program.  I'm not mentioning names here because "innocent until proven guilty", but this story did get me to thinking about this situation.

Over the years there have been numerous stories of physicians and dentists that have fraudulently billed Medicaid programs for services they did not perform.  Just do a Google search on "Medicaid Fraud" and see how many different cases are identified.

The tech side of this is in the world of Artificial Intelligence and Machine Learning.  I've seen some interesting ideas bantered about regarding using these types of systems to search billing records to look for suspicious patterns that might require closer scrutiny.

Those types of systemic abuses have been happening probably as long as there have been public funds paying for goods and services.  The thing is, those abuses plunder funds needed to help those less fortunate receive care.

I feel in the past the reason these types of cases occur is that it is simply too easy and tempting.  Most reimbursement with public funds are very low from a compensation standpoint and even though it's morally and ethically wrong, people can convince themselves that it is only a few dollars and that it just offsets the lower reimbursements.  But it doesn't matter how you justify it, perpetrating fraud is wrong and illegal while also depriving needed funds from others.

While AI may not be the final answer to solving these types of problems, if it can help authorities find and eliminate these types of fraud cases, maybe it will help keep the money available for those who are in need of those services.

Monday, August 30, 2021

FDA Announces: Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng - Letter to Health Care Providers

 In the continuing struggle for healthcare providers to keep patients and staff safe, one of the most important ways to do so is by using N95 Respirators.  With Covid-19 being airborne and transferred by breathing in viral particles that are floating in the air, respirators can provide protection.

Now comes word from the FDA, that some of these devices may not provide the protection that is needed.  Here is the announcement from the FDA:

Announcement from FDA

The U.S. Food and Drug Administration (FDA) is alerting health care facility risk managers, procurement staff, and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd. (Shanghai Dasheng). The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) revoked all respirator approvals previously issued to Shanghai Dasheng because the company did not implement, maintain, and control a quality management system. All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of the loss of NIOSH-approval.  

How to Identify Affected N95 Respirators 

Affected respirators can be identified by referring to the NIOSH approval numbers below and using the label reference from NIOSH.  Respirators marked with a NIOSH approval label that includes any of the approval numbers listed below are no longer NIOSH-approved. In addition, respirators manufactured by Shanghai Dasheng and marketed using another brand name that include any of the approval numbers below are no longer NIOSH-approved:  

TC-84A-4329, TC-84A-4330, TC-84A-4331, TC-84A-4332, TC-84A-4334, TC-84A-4335, TC-84A-4336, TC-84A-4337, TC-84A-4398, TC-84A-4399, TC-84A-4400, TC-84A-4401, TC-84A-4463, TC-84A-4464, TC-84A-4465, TC-84A-4466, TC-84A-4467, TC-84A-4468, TC-84A-4469, TC-84A-4470, TC-84A-4471, TC-84A-4472, TC-84A-4473, TC-84A-4483, TC-84A-4484, TC-84A-4485, TC-84A-4486, TC-84A-4487, TC-84A-8150, TC-84A-8425, TC-84A-8543, TC-84A-8544, TC-84A-8545, TC-84A-8546, TC-84A-8547, TC-84A-8634, TC-84A-8635, and TC-84A-8636.  

Recommendations 

The FDA recommends health care facility risk managers, procurement staff, and health care personnel to:   

In accordance with the CDC’s recommendation, stop using N95 respirators manufactured by Shanghai Dasheng and intended for emergency use (including those bearing other brand names). 

Replace any Shanghai Dasheng respirators with respirators approved by NIOSH that are found on the NIOSH Certified Equipment List. Respirators on the NIOSH Certified Equipment List are authorized under the Emergency Use Authorization (EUA) for NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency. 

Contact group purchasing organizations, distributors, and state or regional resources if you are having difficulty obtaining NIOSH-approved respirators through existing vendors. 

Report any issues with the quality or performance of respirators to the FDA.  See “Reporting Problems to the FDA” below. 

Background 

An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles.  The edges of the respirator are designed to form a seal around the nose and mouth. 

FDA Actions 

The FDA is alerting health care facility risk managers, procurement staff, and health care personnel about serious concerns with the quality of certain N95 respirators manufactured by Shanghai Dasheng. The FDA is assessing the extent of the concerns and is working with NIOSH to understand and address the issue. 

The FDA will continue to keep health care providers and the public informed as significant new information becomes available. 


Thursday, August 26, 2021

Anatomage Spins Out its 3D Dental Technology Business As Osteoid

Almost from the day I began to use CBCT (Cone Beam Computed Tomography) in my practice, which was back in 2008, I was smitten with Invivo's Anatomage software.  When it first hit the market, Anatomage was a truly stunning piece of software.  At the time it was probably the most impressive 3D software available.

In the years since, there have been quite a few other companies that have entered the space and there are now some pretty impressive competitors.  However, Anatomage has a done a tremendous job of upgrading and improving as well.  Even after all these years, Anatomage continues to be one of the best on the market.  I continue using it today for a couple of reasons.

The first reason is the imaging aspect as well as my familiarity with it.  Anatomage has always provided imaging, filters, features, and tools that give me everything I need to evaluate my cone beam images as well as to virtually treatment plant cases.

The second reason I still love it is the program's interface.  Let's face it, a program that provides incredible graphics and tools to enhance those graphics can often be unwieldy.  Anatomage has always been intuitive and easy to use.  I was impressed with it the first time I saw it... and I continue to be.  It has an interface that is easy to understand and the tools are well designed for the end user.  I've evaluated a fair number of CBCT reader programs over the years and many have incredible features but are incredibly difficult to use.  Not so with Anatomage.  The user interface is easy to understand and the program is easy to use.

Now, as it continues to evolve, the company is creating a 3D Dental Division that is is calling Osteoid.  Here are the details:


Anatomage, a market leader in medical visualization technology, announced that the company has spun out its 3D dental business as a wholly owned subsidiary called Osteoid. Calvin Hur, an over 20-year veteran of the 3D design and printing industry, will lead Osteoid as its CEO, where he will oversee strategic direction and product roadmap. Anatomage founder and CEO Jack Choi will continue to serve Osteoid as an advisor.

The move will allow each company to focus on expanded innovation in its core specialty. Anatomage will focus on its medical and educational solutions. Osteoid will focus solely on 3D dentistry solutions, including the award-winning Invivo 3D dental imaging solutions, as well as its Invivo Workspace cloud-based platform, and solutions for precision surgical guide fabrication.

Backed by resources from its Anatomage parent, Osteoid will make significant investments in R&D and Go-To-Market initiatives that deliver even more precision and efficiency in visualizing unique anatomy for implant planning, orthodontic, endodontic and prosthodontic applications, and more. Recognizing the pivotal role of key opinion leaders in the dental and supplier ecosystem, Osteoid also will incorporate customer-driven innovation by developing Osteoid’s solutions cooperatively with strategic partners.

With the dental imaging market projected to grow to $4.1 billion by 2025 (Markets and Markets, March 2020), Osteoid is positioned to capture growing demand for digital dental solutions. For over 10 years Osteoid’s Invivo 3D imaging products have served the broad needs of thousands of dental professionals who give these solutions high marks for high quality 3D rendering and design capabilities for restorations, using an intuitive interface and simple workflow. Invivo solutions help visualize anatomy, diagnose, share cases with other professionals and perform fast and intuitive implant planning.

Forthcoming new offerings including Invivo6 Plus for 3D Design, added features for Invivo Workspace, and added capabilities for precision surgical guide production will help dental professionals to become more connected, for even greater precision and efficiency across their businesses.

“Dental practices need technology partners with a total commitment to innovation, so we can continually improve care to patients. As an Invivo software user I’ve found the product to be extremely precise, but more importantly the people behind the company have been incredibly knowledgeable, with a genuine passion for making sure my cases go well,” said Nima S. Massoomi, DMD, MEd, MD, a maxillofacial surgeon and fellowship-trained facial cosmetic surgeon. “Whether as Anatomage or Osteoid, I have appreciated their commitment to our industry, and look forward to following the company,” Dr. Massoomi said.

“Our team is proud to have earned the trust of dental experts for delivering products that streamline the dental workflow,” said Jack Choi, founder and CEO of Anatomage. “As the separate dental-focused entity, Osteoid can remain on the leading edge of 3D visualization technology for the dental industry.”

“Osteoid is on a mission to deliver the future of modern dentistry, and I’m honored to lead such a customer-driven team,” said Calvin Hur, CEO of Osteoid. “We are more focused and committed than ever to helping accelerate the move to digital dentistry.”

For more information on Osteoid’s family of 3D dental imaging solutions visit www.osteoidinc.com.


Wednesday, August 25, 2021

Software enhancements support a higher level of performance of Primescan and CEREC Primemill

Dentsply Sirona is announcing its latest upgrade for both Connect and CEREC Software giving users both new and improved functionalities, and even better performance[1]. Patient communication is also improved with a new visualization step in the model phase. New firmware makes the intraoral scanner twice as fast, provides a higher-performing scanning experience and gives users access to new workflows and even better usability*.

Charlotte/Bensheim, August 25, 2021. The latest upgrade of the Connect and CEREC Software, 5.2, and an improved firmware provide Primescan and CEREC users with additional options for making treatment more efficient, faster, and more convenient with digital workflows. Primescan intraoral scanner’s latest enhancements optimize performance and improve usability as described as follows; Through its enhanced firmware, Primescan captures up to 1.5 million 3D data points per second. With these enhancements, Primescan is significantly smoother and twice as fast, making it again easier to scan successfully even for relatively inexperienced users*.

CEREC Software 5.2: New features and benefits

Important, user-friendly changes and enhancements have been introduced in CEREC Software 5.2. In addition to general quality improvements, CEREC Primemill users can benefit from the availability of Fast Milling mode for crowns made of IPS e.max® CAD (Ivoclar Vivadent). Additionally, posterior and anterior crowns, direct screw-retained crowns, inlays and veneers can now regularly be produced using the Extra Fine grinding mode to create very smooth and very detailed restorations.

On top of viewing the model directly without restoration selected to facilitate communication with patients, the entire CEREC Guide workflow has also undergone improvements. The mode "Full Range Dynamic Occlusion" was introduced for the articulation calculation. This includes a wider range of lower jaw movement in the calculations and thus helps to detect more functional occlusal interferences*. Chairside dentistry therefore takes another step forward with the CEREC Software 5.2.

Primescan: validated for Atlantis Suprastructures

The software enhancement also opens new possibilities for users around edentulous scanning. Based on the validation of the Atlantis IO FLO-S scanbody, Primescan is now the first and only intraoral scanner validated for a full digital workflow for full arch fixed implant restorations with Atlantis suprastructures– a workflow for implant-supported restorations that requires a high level of accuracy.

The suprastructures are ordered by the dental technician from Dentsply Sirona's Atlantis design and manufacturing sites around the globe. “Usually, Primescan for Atlantis Suprastructures not only reduces chair time and simplifies collaboration with my laboratory, but also increases the level of esthetic predictability and a very good fit,” said Dr. Carlos Repullo, a beta tester practicing in Spain.

Additionally, primary impression taking within the Digital Denture workflow to create an individual, customized impression tray can now be performed with Primescan. This regularly offers the patient a more comfortable start into the manufacturing process of their prosthesis.

Connect SW 5.2 now supports bridges on implants

This Connect software update brings new possibilities to the implant workflows. Due to Primescan’s very high level of accuracy, dentists can now perform long span implant supported bridges, for example “all on 4” or “all on 6” cases, depending on the individual case. This means a new indication for practitioners working with Connect Software.

“Primescan firmware enhancements make the digital workflow even faster and easier than before*,” explained Dr. Alexander Voelcker, Group Vice President of Global Digital Solutions Marketing at Dentsply Sirona. “In addition to significantly increased speed, the smoothness of the scan has also been improved*. For clinicians working with Primescan in their practice, these improvements regularly mean more efficient workflows, even greater reliability, and, at the same time, a very comfortable patient experience.”

Learn more about Primescan and connect with dental industry professionals at Dentsply Sirona World 2021

This year’s Dentsply Sirona World will be a three-day event in Las Vegas from September 23-25. The event comprises General Sessions, a live surgery, Breakout Sessions within 12 educational tracks, an exhibit hall, celebrity entertainment, health and wellness sessions, and numerous networking opportunities for the dental community. This year will also have a virtual registration option to access the event virtually, as well as an option to live stream the daily general sessions and live surgery for free to maximize the opportunities to reconnect.

Onsite participants will have the exciting opportunity to hear from inspirational speakers live, including Mel Robbins, whose popular TEDx talk has been viewed more than 25 million times, and be treated to three evenings of unforgettable entertainment, including a concert from this year’s headliners, the DJ duo The Chainsmokers, a Grammy-winning electronic music and production duo. 

Clinical education is paramount to empowering dental professionals to provide the best possible care to their patients, and our extended program will combine product demonstrations and experiences from experts from all over the world. Dentsply Sirona World 2021 is the ultimate dental experience, offering engaging and dynamic speakers, educational sessions, networking opportunities, health and wellness sessions and educational webinars and more.


Tuesday, August 24, 2021

Starting Evaluation of PacDent's ProMate™ Cordless Hygiene Handpiece



We are currently getting ready to evaluate the new cordless prophy handpiece from PacDent, the ProMate™CL.  Every member of the hygiene team will be giving it an extensive spin (literally) and I'll be reporting back here what they report back to me.

Here are the specifics from PacDent:

The ProMate™ CL Cordless Hygiene Handpiece has been designed to provide the clinician with an ergonomic handpiece that delivers independence from heavy cord-drag, dual-mode speed control, and operator comfort during prophylaxis procedures. Pac-Dent's cordless prophy handpiece provides the flexibility of using any preferred disposable prophy angles (DPA) on the market. The sterilizable outer sheath has been designed to be steam autoclavable in compliance with the CDC’s sterilization and infection control guidelines. A disposable polyethylene barrier is available to cover the handpiece


Cordless. Effortless. Extraordinary.


● Made with the Clinician in Mind – Cordless design eliminates drag and pulling
    and increases mobility

● Ultralight Construction 3.8 oz. – 20% lighter than industry-leading low-speed
    handpieces

● Extraordinary Performance – Dual-mode speed control with 6-speed settings

● Dual-Mode Control – Ergonomic, quick-touch button and Bluetooth-powered
    foot pedal

● Universal Compatibility – Use all your favorite disposable prophy angles

● Amazing Battery Life – Lasts through a whole day’s worth of procedures





 

Monday, August 23, 2021

AAE Position Statement on Vital Pulp Therapy

 


Last week the American Association of Endodontists released a position paper on Vital Pulp Therapy.  While the group is obviously focused on endodontic specialists and the challenges they face, this topic is something that applies to anyone performing restorative as well as endodontic procedures in the clinical environment.

VPT (Vital Pulp Therapy) is a topic that has received a lot of interest and a fair bit of research lately, especially with the increasing number of biomaterials entering the market.  I found it a very informative read. 

I have posted the information here.  The association has the paper available as a pdf file on their website.  If you would like to have the paper in its entirety and save the pdf, follow this link.  

Introduction 

The American Association of Endodontists is dedicated to excellenc3e in the art and science of endodontics and to the highest standards of patient care.  The basis for endodontic treatment utilizes the best available evidence from scientific and clinical studies in concert with the accumulated clinical knowledge and judgment of the practitioner.  

Vital pulp therapy (VPT) techniques are means of preserving the vitality and function of the dental pulp after injury resulting from trauma, caries, or restorative procedures. VPT procedures have traditionally included indirect or direct pulp capping, and partial or complete pulpotomy.

For years, the focus of VPT was on the preservation of the radicular pulp in immature adult teeth, so as to assure completion of root formation (apexogenesis). Today, the focus of VPT is broader; practitioners may have treatment options to consider other than pulpectomy or root canal therapy (RCT) in mature teeth, including teeth previously thought to have irreversibly inflamed pulps. 

This position statement addresses diagnostic considerations, caries management, pulp management, placement of biomaterials, and restoration.  The intent of the authors is to consider vital pulp therapy from the perspective of the practice of specialty Endodontics. However, this statement may be of use to any practitioner in assessing whether they have the appropriate expertise and armamentarium to perform VPT procedures in appropriately selected cases.

Diagnostic Considerations for VPT 

A basic tenet for clinical dentistry is that treatment is recommended and performed after the formulation of a sound diagnosis. This has been considered of particular relevance when vital pulp therapy was to be considered. 

The current AAE diagnostic terminology assigned a vital pulp to one of three categories: "normal", "reversible pulpitis" or "irreversible pulpitis" (which could be symptomatic or asymptomatic).

Traditionally the designation of a pulpal diagnosis is based upon the clinician’s consideration of a patient’s pain history, and appropriate clinical testing to assess the status of the pulp including the application of cold stimulus and electric pulp testing. These tests would be best termed pulp sensibility tests, as definitive tests of pulp vitality, such as measures of pulp oxygen tension, are not currently available for clinical use.

The primary provoked response to pulp sensibility testing, indicating more severe pulpal inflammation is described as an exaggerated and “lingering” response to cold stimulus, with the underlying pathomechanisms of c-fiber sensitization and inflammation-induced hypersensitivity.

In addition to such pulp sensibility testing, percussion tests may infer pulpal conditions from the presence of symptomatic apical periodontitis; with the presence of percussion pain, i.e., mechanical allodynia, the pulp is considered to be in an irreversibly inflamed state.

Diagnostic quality intraoral radiographs of the suspected teeth are recommended to evaluate accurately the extent of root formation and other concomitant hard tissue changes.

Historically, there has been a widespread belief that, even in aggregate, clinical test results are not well correlated with histologic descriptions of the pulpal status.

The viewpoint that VPT is an option only for
cases where testing results were consistent
with “reversible pulpitis” has recently been challenged.10,11,12 Based on clinical, biological and theoretical considerations, the irreversibility of the pulpal disease has come into question. Histologic evidence of the progression of pulpitis suggests that there is no discrete boundary that would render a pulp beyond repair.11 Rather, pulpitis may be interpreted as a temporally and spatially graded disease, with some suggesting the following terms for gradation: “initial”, “mild”, “moderate” and “severe pulpitis.” 

Research is underway to understand the role of inflammatory mediators that better indicate pulpal status.13,14 For example, point of care analysis could use dentinal fluid15 (without pulp exposure) or pulp blood16 (with pulp exposure) to determine markers associated with tissue degradation, such as matrix metalloproteinase-9. 

In the absence of clinically available molecular biologic tests, direct observation of the pulp (use
of a surgical microscope is recommended) can
give relevant information for determining the suitability of the case for VPT. First, a misdiagnosed necrotic pulp can be accurately identified. Secondly, direct observation of pulp tissue during and after achieving hemostasis offers additional diagnostic information about the condition of the pulpal tissue.17 Utilizing direct visualization of the pulp, it appears that even symptomatic pulps may be candidates for VPT.

Caries Management 

Complete caries removal is essential to eliminate infected tissues and visualize pulp tissue conditions under magnification when pulpal exposures occur.19,20 Residual caries compromises necessary observations of pulpal inflammation levels and areas of potential necrosis. Accordingly, predictable management of vital pulp tissue should not be performed without complete removal of both demineralized enamel and infected dentin. 

Hard or firm dentin and dentin below white
spot enamel lesions is infected by bacteria in
both active and arrested lesions. Specifically, histobacteriological studies have consistently shown the presence of chronic inflammatory
cell infiltrates and subclinical pulp inflammation where carious tissues are retained, thus potentially compromising pulp vitality.  Additionally, adhesion of bonding resins to sound dentin has shown higher micro-tensile bond strengths compared to caries-affected dentin.

The use of caries detectors or laser fluorescence during caries removal can be helpful adjuncts to assist the clinician in removing diseased tissues, particularly when close to the pulp cavity.25,26,27 Therefore, the clinician can focus on complete removal of demineralized infected dentin, rather than avoiding pulp exposure, to improve the chances of pulpal repair.28 Detectors can create an objective standard for all clinicians during caries removal without reliance exclusively on clinical philosophy or subjective judgement.

Use of Sodium Hypochlorite 

Sodium hypochlorite is an antimicrobial solution that provides hemostasis, disinfection of the dentin- pulp interface, biofilm removal, chemical removal of the blood clot and fibrin, and clearance of dentinal chips along with damaged cells at the mechanical exposure site.

Examination of pulp tissues after exposure with magnification is a critical step in pulp assessment. Hemorrhage must be controlled to allow clinical assessment of inflammatory levels and identify potential necrotic tissues that require removal before application of an appropriate biomaterial. Hemostasis for the pulp tissue is typically achieved by bathing the resected pulp tissue in sodium hypochlorite for 5 to 10 minutes, although recommended durations may vary, either via direct passive irrigation or on a sodium hypochlorite-soaked cotton pellet.

Although several hemostatic options are available, sodium hypochlorite can be used safely in direct contact with pulp tissue at various concentrations, from dilute solutions to full bottle strength, without compromising pulp integrity.  Sodium hypochlorite has not been shown to adversely alter pulp cell recruitment, cytodifferentiation, and hard tissue deposition.  Sodium hypochlorite also eliminates composite staining, addressing an aesthetic concern. 

Use of Contemporary Materials in VPT 

Calcium silicate cements (CSC) have gained momentum for use in vital pulp therapy (VPT) procedures.50,51 CSCs are a class of materials
that include tricalcium silicates, dicalcium silicates, hydraulic calcium silicate cements,
and “bioceramics.” Clinical outcomes have demonstrated consistent success with these materials and mineral trioxide aggregate (MTA) is one of many tricalcium silicates that is widely used and the most extensively studied. When MTA and other CSCs are used for VPT procedures in permanent teeth with symptomatic or asymptomatic irreversible pulpitis, success rates range from 85-100% at 1-2 years.  However, it is noteworthy that calcium hydroxide, glass ionomer cements (GICs) and resin- based materials trail in clinical outcomes and demonstrate a lower range of success varying from 43%-92%.

Immunomodulatory effects of the new generation of biomaterials provide an added and much needed benefit to their biocompatible, osteogenic and bioactive properties.  The formation of mineralized barriers using CSCs show improved quality over calcium hydroxide-based materials.

Silicate materials also possess favorable physicochemical characteristics that include high alkalinity, intratubular mineralization, inhibition
of biofilm formation, reduction of robust pro- inflammatory mediators and post-operative pain during dental pulp procedures.57,58,63,70,71 The newer generations of CSCs do demonstrate improved setting times72,73,74 including modified compositions that reduce tooth discoloration.61,71,72,73,75 The choice of a biomaterial must therefore be made on existing evidence with considerations for patient centered outcomes, reliable mineralized tissue formation and continued pulp vitality. 

Immediate Placement of Permanent Restorative Material 

Restoration of the teeth is a critical step in endodontic procedures. Immediate restoration should be a part of the restorative treatment plan for a tooth receiving VPT. 

Teeth undergoing VPT using CSCs as the primary sealing material and restored immediately
with a long-term restoration have a high
success rate.  Although studies have shown some success with delayed final restoration in the short to medium term, long-term assessments have demonstrated that a minimal time span84 between placement of a foundational restoration after vital pulp treatment is a strong predictor for successful outcomes.

Indicated advantages of immediate restoration include benefits in the prevention of microleakage, protection of the biomaterial layer, reduction of post-operative sensitivity and thermal conductivity, and establishment of a foundation for cuspal coverage restoration should it be required. No negative impacts of restoring the teeth immediately have been indicated.

An appropriate waiting period is recommended prior to additional tooth preparation for definitive (cuspal coverage) restoration. A practitioner, using professional judgment and clinical expertise, should consider absence of signs and symptoms and susceptibility of the tooth to fracture to whether the tooth is ready for a definitive restoration after completion of VPT.

Summary

The primary goal of VPT procedures is the creation of optimal conditions for pulp tissue repair and preservation. The amount of pulp tissue removed or retained is dependent on tissue viability assessments based on access for visualization to evaluate hemorrhage control and clinical tissue removed or retained is dependent on tissue viability assessments based on access for visualization to evaluate hemorrhage control and clinical tissue appearance. 

A pre-treatment diagnosis of irreversible pulpitis is not necessarily an indication for pulpectomy, as more conservative treatment could be considered. 

Procedural decisions for the amount of pulp tissue retention or removal should be based on operator assessments, clinical judgement, overall treatment plan, and the patient’s general oral and systemic health status. Authors would encourage additional clinical trials to assess long-term outcomes of vital pulp therapy and the development of chairside techniques utilizing biomarkers to assess pulpal viability. A review of the endodontic diagnostic terminology used to classify the severity of pulpal disease is also warranted. 


Thursday, August 19, 2021

Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

 The rumor has been circulating about potential booster shots needed for protection from Covid-19.  Here is the latest press release from the FDA:


Today, public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan for COVID-19 booster shots for the American people.

The statement is attributable to Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC); Dr. Janet Woodcock, Acting Commissioner, Food and Drug Administration (FDA); Dr. Vivek Murthy, U.S. Surgeon General; Dr. Francis Collins, Director of the National Institutes of Health (NIH); Dr. Anthony Fauci, Chief Medical Advisor to President Joe Biden and Director of the National Institute of Allergy and Infectious Diseases (NIAID); Dr. Rachel Levine, Assistant Secretary for Health; Dr. David Kessler, Chief Science Officer for the COVID-19 Response; and Dr. Marcella Nunez-Smith, Chair of the COVID-19 Health Equity Task Force:

“The COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant. Recognizing that many vaccines are associated with a reduction in protection over time, and acknowledging that additional vaccine doses could be needed to provide long lasting protection, we have been analyzing the scientific data closely from the United States and around the world to understand how long this protection will last and how we might maximize this protection. The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease. Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.

“We have developed a plan to begin offering these booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence. We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster. We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them.

“We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine. Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.

“Our top priority remains staying ahead of the virus and protecting the American people from COVID-19 with safe, effective, and long-lasting vaccines especially in the context of a constantly changing virus and epidemiologic landscape. We will continue to follow the science on a daily basis, and we are prepared to modify this plan should new data emerge that requires it.

“We also want to emphasize the ongoing urgency of vaccinating the unvaccinated in the U.S. and around the world. Nearly all the cases of severe disease, hospitalization, and death continue to occur among those not yet vaccinated at all. We will continue to ramp up efforts to increase vaccinations here at home and to ensure people have accurate information about vaccines from trusted sources. We will also continue to expand our efforts to increase the supply of vaccines for other countries, building further on the more than 600 million doses we have already committed to donate globally.”

###

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.