In a previous blog, I wrote about how we use multiple flavors of topical in my dental practice and the positive patient experience this creates. In this article, we will look at the topical application technique we use to create maximum patient comfort.

I have often debated in my mind whether topical actually makes patients feel more comfortable when anesthetic will be injected. The scientific literature confirms it works great on the surface of mucosa, but it does not reach nerves under the gums or in teeth. From working with my patients, I know it makes a difference to them in how they perceive the injection feels. And there are studies in which patients overwhelmingly self-report that the initial pinch feeling of the needle entering the tissue is reduced after topical.

Before applying topical, thoroughly dry the area so the topical goes directly on the tissue you want to numb. If topical is applied to saliva, its effectiveness is greatly reduced. Ideally, let the topical work for 60 seconds but minimally 30 seconds prior to beginning the injection. My technique is to thoroughly dry the mucosa, swab the dry area with topical, leave the cotton tip applicator in place against the mucosa, cover it with a 2×2, and have the patient close to hold it in place while I watch the clock for 60 seconds to make sure I am not rushing.

To deliver anesthetic I use The Wand computer-assisted anesthetic delivery technology. While I am waiting for the 60 seconds, I explain to the patient that the anesthetic delivery may be different than they have experienced before and how the anesthetic will be delivered.

In my last blog, I wrote about the value of offering patients a choice of topical flavors. I can also fill some of the 60 seconds by asking the patient if the topical administered tastes like the flavor of topical they selected. As soon as the 60 seconds have passed, I immediately remove the 2×2 and cotton tip applicator and begin delivering the anesthetic.

There is good science behind some types of topical acting faster than 60 seconds, so you may want to do some research and select one of these types.

Even if you think topical is not effective, think about the placebo effect topical has on the patient. We are doing something to improve their comfort. We are actively doing something to make the procedure more comfortable and to help them through the process. I believe this act of caring has value to the patient that even exceeds the value of the numbing effectiveness reported in clinical trials.

Cannabidiol, commonly known as CBD, is getting significant attention in new advances of pain management for its non-psychoactive therapeutic properties. Topical CBD oil has been suggested as a way to non-invasively treat pain caused by temporomandibular disorders. But does the science currently support CBD oil or even prove its efficacy versus a placebo?
CBD smoothies, CBD cream, CBD bath bombs… the consumer market is flooded with a variety of premium products touting everything from anxiety reduction to chronic pain treatment. If you haven’t been asked for your medical opinion about CBD yet, you may be soon.

Topical CBD oil is expensive and trendy. Roll-on applicators are often combined with other active ingredients like menthol and arnica to soothe the symptoms of pain. Roll-on CBD may be infused with essential oils, so it even has a therapeutic aroma. With attractive green packaging and clever names to boot, the purchase can be a no-brainer for those suffering from aches and tension in their jaw.

Evidence-based dentistry demands a suspicious eye. Is all this external dressing, pleasant smells, and clever marketing covering up a dearth of clinical evidence? Let’s take a dive into the science:

What CBD Is and What CBD Isn’t

Cannabidiol has come to prominence as the safer alternative to tetrahydrocannabinol (THC). Evidence has shown it may be effective in the treatment of childhood epilepsy.¹ There is even an FDA-approved CBD-based treatment, Epidiolex, for two severe forms of epilepsy.²

Besides this specific use in the management of epileptic seizures, CBD is sold as a supplement.¹ The number one issue here is the lack of regulation over supplements. You can’t be certain that the amount of CBD stated on the label corresponds to the actual levels in the formulation.¹ Even more concerning, there is no widely accepted, clinical trial approved therapeutic topical or oral dose of CBD designated for the management of chronic pain.¹ Can a treatment be ethically recommended when there is no consensus on effective, safe dose?

Unlike THC, CBD does not cause a high. But it can have side effects such as nausea or even impact the level of medications in the blood.¹ We know very little about the effects of cannabidiol in the context of large sample size human clinical trials. How long should a patient apply CBD for? At what dose should they apply it? How regularly? The answers to these questions are not currently known.

CBD and TMD: Friend, Foe, or Placebo?

A 2020 systematic review with meta-analysis of topical intervention efficacy for temporomandibular disorders compared the current data on treatments such as nonsteroidal anti-inflammatories (NSAIDs), cannabidiol, capsaicin, bee venom, and more.³ Topical therapies are especially attractive because of the serious consequences to long-term oral NSAID use for TMDs.³

Topical doses of a drug or therapeutic can bypass the debilitating side-effects of systemic treatment.³ Topical NSAIDs include diclofenac sodium and methyl salicylate.3 Therapies like bee venom and CBD are called “nutraceuticals,” which refers broadly to food-derived alternatives to pharmaceuticals, usually sold as supplements.³

The 2020 review was only able to find 9 studies regarding topical treatment of TMDs that met rigorous criteria for quality of evidence while also qualifying as randomized controlled trials.³ For topical NSAIDs, the review found no clinically significant difference compared to a placebo.³ Interestingly, ultrasound therapy was found to reduce pain, but applying an NSAID gel with ultrasound had no statistically significant difference compared to ultrasound without the gel.³

The effect of bee venom and capsaicin was similarly inscrutable, with few relevant studies including the proper data values or standard deviations to conduct a meta-analysis.³ The evidence in general was low quality or showed little effect.³

CBD also suffered from a lack of high-quality evidence in the form of studies in humans.³ Animal models have shown that “transdermal cannabinoids” may reduce pain and inflammation, but there is currently no clear evidence for long-term benefits in humans.³

Why is the research for topical treatment of TMD-associated pain so poor? The answer is small sample sizes, poor blinding, and unreported funding sources.³ Because of this, we don’t know whether demonstrated effects, if any, apply to a larger population.

Statistics have less meaning in small sample sizes. Poor blinding means that bias cannot be controlled. Lack of clear funding disclosures may also influence blinding and make it difficult to trust whether research was conducted in good faith.

The Future of CBD in Dentistry

Though data regarding CBD for TMDs is severely lacking, the future may offer some hope. If motivated researchers feel passionately about reducing the burden of chronic pain for sufferers of temporomandibular disorders, they may be able to put forward the time, money, and effort necessary to distinguish the minimum safe yet therapeutic dose of CBD.

They will also have to determine its ideal application parameters and any necessary or helpful active ingredients. They’ll need large numbers of study participants, including hundreds of individuals for control and experimental groups, and a well-considered experimental design.
That outcome may take many years. In the meantime, topical CBD will remain the equivalent of a high-end massage oil.

References:

1. MD PG. Cannabidiol (CBD) — what we know and what we don’t. Harvard Health Blog. Published August 24, 2018. https://www.health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-2018082414476
2. FDA Approves First Drug Comprised of an Active Ingredient Derived from Marijuana to Treat Rare, Severe Forms of Epilepsy. FDA. Published March 27, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms
3. Mena M, Dalbah L, Levi L, Padilla M, Enciso R. Efficacy of topical interventions for temporomandibular disorders compared to placebo or control therapy: a systematic review with meta-analysis. J Dent Anesth Pain Med. 2020;20(6):337-356. doi:17245/jdapm.2020.20.6.337

There is a practice in Ohio I recently work with, in which the dentist and a young hygienist were having a chat about the idea of restorative partnership. When she first heard the idea, her reply was beautiful. She said, “Oh you want me to learn about treatment planting,” and I thought that was just the coolest thing ever because that is what we get to do when we think about developing patients over time. We are planting ideas…planting seeds that we can grow.

When I was still working as a hygienist, I found I was good at talking with patients about what was going on in their mouths… what I saw… what the possibilities were. And I even enjoyed dreaming with patients about what their mouth could be like if they chose to do dentistry proactively rather than reactively. So, it is interesting to me how many hygienists become nervous about the idea of talking about dentistry with patients.

This nervousness exists because we have been taught in and out of hygiene school that it is illegal for hygienists to diagnose. This one barrier has become an incredible obstacle to having conversations about current conditions and possibilities with patients. It does not need to be this way.

When I think about restorative partnership, now, I think of it as treatment planting! The doctor diagnoses and discusses the potential of treatment with the patient. And during recall appointments, the hygienist has amazing opportunity to plant seeds during encouraging conversations. A restorative partner deeply appreciates the developmental path that dental patients are often on and looks for opportunities to plant seeds of awareness, curiosity, and of course, possibilities.

Wouldn’t it be cool if a patient came in one day and said, “You know, we’ve been talking about this idea of comprehensive care… we’ve been talking about the idea of restoring this quadrant… and I want to go ahead with it.” Wouldn’t it be exciting if suddenly what you have been talking about blooms like a beautiful flower?

If you have been thinking about having a conversation with your team members about restorative partnership, starting the conversation around “planting seeds” would be enormously helpful. Think about looking at cases together…creating learning opportunities in your office, where you can start sharing more of your knowledge about what it takes to work in a patient’s mouth, examining photographs together and talking about what you see, talking about the implications and consequences of not having treatment done, and what the benefits could be of thinking about treatment.

The restorative choice is always in the patient’s hands, and what I find to be most exciting about the restorative partnership is the partnership that we, as dental professionals, get to develop with our patients.

Despite headlines you may have read, heart disease is still the number one killer in the U.S., followed by cancer and then (hopefully only temporarily) COVID-19. Gum disease is on the rise in this country. This condition affects much more than just a person’s mouth. We need to shut down the dangerous anaerobes that live in our tissue and bone that drive the oral and systemic inflammation. The bacteria that live in our mouth do not stay in our mouth! Hygienists are not only cleaning deposits off of teeth; they are managing dangerous bacteria and saving lives!

Patients see their dentist more often than they see their physician. The start to providing optimal care is having informative conversations with our patients when discussing their health history, their medications, and the tie in their periodontal and endodontic health.

Married to a cardiologist, it was beneficial for both my dental patients and his medical patients to receive integrative care, and to that end, we worked together to build a center for my restorative practice that includes oral-systemic health diagnostics, counseling, and treatment.

Pushing the Standard of Care

My practice, Complete Heath Dentistry of Columbus, is distinguished from other practices by pushing the standard of care to treat patients based on his or her risk factors for developing systemic health issues. Saliva/oral DNA testing enables us to take this proactive health approach. This testing allows us to learn if our patients have dangerous oral pathogens. It helps guide us on how to better treat our dental patients with periodontal therapy and with oral probiotics, as well as Perio Protect trays.

My husband, Dr. Eric Goulder, and I opened the first medical center in the United States with an accredited Cardiologist and Dentist to practice the Bale Doneen Method testing and care under one roof. We passionately believe a medical Bale Doneen provider cannot optimally help their patient without the assistance of a dental team that understands the value of their work.

With every patient, we discuss oral health risk factors for cardiovascular disease and strokes. We use saliva/oral DNA testing to proactively calculate the CVD risks of our patients with the recommendation they create a health plan with their doctor geared toward overall health. With focus on prevention and the elimination of disease, we work with patients to achieve optimal oral and systemic health.

Pushing Dental-Medical Integration

Across the country, dentists are teaming with cardiologists to better understand the oral-systemic connection and to help their patients discover developing risk factors for heart attack and stroke, among other diseases such as diabetes. You do not have to have a cardiologist under your roof to similarly help your patients.

You can explain to your patients that one of the most painless tests that can reveal hidden heart attack or stroke risks is a carotid artery scan (CIMT scan) that measures carotid intima-media thickness. It is an important test for individuals with few risk factors for developing cardiovascular issues. Under traditional care, 75 percent of heart attacks happen in people with normal cholesterol levels. Through this no radiation ultrasound procedure, the neck is examined so that a doctor can uncover whether or not a patient is heading for health problems. This screening detects atherosclerosis, a condition where deposits hide within the arteries. Also, it is possible to find the “age” of a patient’s arteries.

Through CIMT ultrasound testing, a cardiovascular problem can be identified 10-15 years prior to an event. While 50% of the population does not know they have a growing cardiovascular problem, this simple test provides an early diagnosis for lifestyle counseling and dental-medical treatment.

Working with your patients and their physicians, you can also recommend the NT-ProBNP blood test that is a part of the blood testing involved with the Bale Doneen Method. This test measures the amount of BNP in the blood.  When the heart is under stress, the body excretes high levels of this substance. If elevated levels are detected, it is a red flag that a person may be heading for a stroke or heart attack.

Dr. Eric Goulder and I are on a mission to push physicians to be proactive, to understand what is going on inside arteries, discover why the disease is present, and observe the disease stabilize after treatment. I encourage you to become familiar with the Bale Doneen Method if you have not already done so and become familiar with cardiologists in your area who can be of assistance to your patients. Two-way referrals are a natural outcome of developing these relationships, and patients are very appreciative.

Key Points:
• Platelet-Rich Plasma (PRP) is not FDA approved. It is an “off-label” therapy.
• PRP is considered safe.
• There is no standardization of PRP treatments, making it difficult to determine how it heals or encourages healing.

If you regularly work with an oral surgeon, you’ve probably heard the term Platelet-Rich Plasma or “PRP.” Put simply, PRP is a technique where blood is drawn from a patient and spun in a centrifuge to produce a clot composed of the patient’s own platelets. This clot is then placed into a wound or surgical site to stem the flow of blood and promote healing. In short, a clinician removes the red blood cells from whole blood.

PRP is an autologous cell therapy. This just means that cells are used on the same patient they came from.

What is PRP and How is it Regulated?

PRP is a relatively simple procedure that is favored in clinical practice due to its safety and perceived efficacy. Because it is drawn from a patient’s own blood and is similar to a previously cleared therapeutic, it has so far bypassed the lengthy and expensive process of FDA approval for biologics.¹ PRP is not FDA approved, though it is cleared legally for specific therapeutic uses, and therefore guidelines must be followed to adhere to FDA regulations.¹

A 2018 review of the economics and regulatory outcomes for PRP describes the treatment’s 5-to-10-year outlook as enormous, citing “between 380 million and 4.5 billion (USD)” in growth.¹ Procedures may start at a minimum of $500 and can be thousands of dollars.¹

What this means in short is that PRP is an expensive treatment lacking in proven clinical trial data and is not paid for by insurance.¹ This may not sound like a promising description, but it doesn’t mean the treatment is ineffective or not worth the money depending on its application.

PRP is regulated based on certain qualities of how it is collected from the patient and the number of platelets per volume.¹ It often contains a unique combination of leukocytes (immune cells/white blood cells), platelets (cell fragments without a nucleus), and fibrin (fibrous protein necessary for clotting).¹

Why Clinical Trial Data is Limited for PRP

The large variation in techniques used for the collection of PRP, as well as inherent differences in composition that can be attributed to individual patient differences, make it supremely difficult to study the efficacy of the treatment.¹ It also makes it very challenging to compare different treatment styles. It is complicated to design a study with the necessary “statistical power” to draw a valid conclusion from the data. This is true of many biologics or stem-cell based therapies. How do you determine that the effect you are witnessing is truly a result of the cell-based therapy? Moreover, what part of the therapy is generating the effect? Cells are unpredictable.

In order to study the effect of PRP therapeutically, it would be necessary for multiple studies with large sample sizes to use the exact same materials and experimental conditions, all the way down to the exact collecting tube and centrifugation speed.¹ Clear and replicable methodology (the exact steps taken, in what order, with what materials, and for what duration) is often missing in scientific literature due to fears over proprietary information or lack of thorough reporting.

PRP is a Mixture of Many Different Therapeutic Substances

When trying to understand or tease out how PRP effects the surrounding tissue, it’s helpful to think of the clot as an intentionally overcooked minestrone. This soupy, gelatinous mixture was made by a brilliant chef with a few screws loose. We know there are tomatoes and carrots and potatoes, with some vegetable broth and a bit of salt, but some of the ingredients are difficult to identify. Did she throw in a dash of dill? Is it the pepper that’s leaving such a strong aftertaste? Does the minestrone taste good mainly because of the tomato? The tomato is everywhere, so it’s easy to differentiate. But that can’t possibly be the entire picture contributing to such a delicious soup du jour.

PRP is infinitely more complicated than a well-made minestrone. It contains growth factors, AKA a protein or hormone that regulates cell behavior, such as proliferation or healing.¹ But it also contains the immune cells mentioned earlier. And ions. And many other molecules and proteins with diverse purposes in the body. It’s hard to offer a therapy to someone if you don’t fully understand why it works. You know the soup is tasty, but what about this exact combination of ingredients is making it better than the one you make at home from a can?

So far, PRP has been deemed relatively safe.¹ It is considered an “off-label” treatment that was cleared, but not approved, by the FDA under the 510(k) substantial equivalency pathway.¹ This pathway allows transplanted human tissue or other medical devices to be cleared if it similar enough to a prior cleared device.¹ There are pros and cons to off-label use of drugs and biologics.¹ One major con is that there is a dearth of scientific evidence in humans explaining why and how the biologic works.¹

PRP in Oral Surgery

PRP is used for a variety of orthopedic purposes. Oral surgery is just one of the many ways in which this therapy is leveraged. A 2013 study of PRP in dental surgery found mixed results in the literature.² The goal of PRP for tooth extraction is to manage the bleeding and pain of extraction sockets while encouraging bone formation.² Some studies found improved benefits to post-operative pain, bleeding, and bone healing, whereas other studies found no significant effects of PRP, especially long-term for bone growth.² Overall, the review indicates that there is evidence of PRP being effective for soft tissue but not for bone regeneration.²

The body of knowledge regarding Platelet-Rich Plasma will continue to grow in the next decade. Over this period of time, perhaps the FDA approval process will be fruitful and standardized treatments will make their way onto the market.

References:

1. Jones IA, Togashi RC, Thomas Vangsness C. The Economics and Regulation of PRP in the Evolving Field of Orthopedic Biologics. Curr Rev Musculoskelet Med. 2018;11(4):558-565. doi:1007/s12178-018-9514-z
2. Albanese A, Licata ME, Polizzi B, Campisi G. Platelet-rich plasma (PRP) in dental and oral surgery: from the wound healing to bone regeneration. Immunity & ageing. 2013;10(1):23-23. doi:1186/1742-4933-10-23