FREQUENTLY ASKED QUESTIONS

PATIENT ASKED QUESTIONS
  1. 0
    Is OMIT effective?
    The oral mucosal tissue is known to be a natural site for promoting immune tolerance. Previous studies have demonstrated that when allergenic proteins are introduced to the oral cavity, they are contacted and processed by immune cells that are embedded in the oral tissues. Delivery of allergenic proteins to the oral cavity can occur via several modes, including combination of the proteins with OMIT specialized toothpaste. A recently published study demonstrated that OMIT was able to improve the quality of life in people suffering symptoms of respiratory allergies while reducing symptoms and medication use comparable to that of sublingual immunotherapy drops (SLIT). [1]
  2. 1
    What is the youngest age for a patient to be tested for allergies?
    As a general statement, pediatricians do not test until after a child’s first birthday. This is completely up to the pediatrician and the needs of the patient, based on clinical and family history.
  3. 2
    Is there an age limit for the testing and/or immunotherapy treatment?
    No. Both the finger stick test and the Allerdent® OMIT treatment can be recommended at any age when it becomes necessary.
  4. 3
    Are there any side effects using Allerdent® OMIT based toothpaste?
    It is normal in the first 2 weeks of using the toothpaste to experience some tingling, itching, or mild swelling in the lining of the mouth, which resolves spontaneously. Other than this, there are no severe side effects reported.
  5. 4
    Should patients expect any irritation or sores from the toothpaste at all?
    While mild, transient irritation in the mouth is common during the first 1-2 weeks of OMIT, sores in the mouth have not been reported. But if they occur from other medical reasons, the physician should consider decreasing the dose of OMIT or holding the therapy until the sores heal.
  6. 5
    Can OMIT using Allerdent® replace normal toothpaste?
    Yes. It is a fully functional toothpaste that will clean your teeth. OMIT based Allerdent® contains same ingredients as are used in standard, non-fluoridated toothpastes. Allerdent® behaves, tastes, and smells like standard toothpastes. Berry and mint flavored Allerdent® are currently available. Since the dosing with Allerdent® is generally recommended to be 2 minutes only once per day, patients can use their own brand of toothpaste at other brushings.
  7. 6
    What happens if another child uses the Allerdent® toothpaste?
    There is no harm other than wasting a prescribed toothpaste. They will simply receive some allergens to which they are very likely not allergic.
  8. 7
    Is the Allerdent® toothpaste FDA approved?
    The allergy extracts that are used for OMIT based Allerdent® are FDA-approved for injection underneath the skin (subcutaneous) for the purpose of allergy desensitization and are used in SLIT. Different extracts may be mixed together in specific combinations and, in addition, may be administered without needles (sublingual immunotherapy - SLIT). This is termed “off label” usage of extracts and is common for a wide variety of medications, supported by extensive medical literature. When a medication is used in an “off label” fashion, insurance companies may not reimburse it. However, a lack of FDA approval does not mean that a medication is ineffective, unsafe, or hasn’t been studied.
  9. 8
    What is in the Allerdent® toothpaste?
    In addition to the regular toothpaste ingredients, Allerdent® contains the natural allergen non-food proteins obtained from a pharmacological source that are driving the patient’s symptoms and have thus been prescribed by the physician to treat the non-food allergies identified in the finger stick blood test using only 10 drops of blood.
  10. 9
    Is there a limit on how long I can use the Allerdent® toothpaste?
    Most immunotherapy regimens take 3-5 years. Under supervision of a medical professional, a longer treatment regimen may be possible.
  11. 10
    When will I see results from the Allerdent® toothpaste?
    As with other allergy immunotherapy treatments, many patients on OMIT based Allerdent® may begin noticing a reduction in symptoms and medication use within the first few months. However, immunotherapy regimes generally take 3-5 years to build up and maintain long-term, persistent tolerance to the allergens, even though symptom reduction has already been experienced by the patient. It is important for patients to continue with immunotherapy even after they start to feel better.
  12. 11
    Can I build up a tolerance to Allerdent®, such that the symptom reduction becomes diminished over time? This is a common issue with antihistamines and other symptom management medications.
    No - This should not occur. All allergy immunotherapies, including OMIT, have the effect of treating the actual immunological roots of the disease. Immunotherapies like Allerdent® are therefore known as “disease modifying” therapies. Conversely, antihistamines (like all other over the counter drugs) work by temporarily reducing or masking the symptoms of allergy. They do not have a significant effect on the immunological cause of the disease. Accordingly, long-term use of antihistamines can sometimes gradually reduce their effect on patients, which can be frustrating.
  13. 12
    Why is Allerdent® toothpaste (OMIT) more effective than subcutaneous allergy shots (SCIT)?
    There is no data yet which compares efficacy of OMIT to that of SCIT. However, patients may find that self-administering allergy immunotherapy by brushing their teeth is easier for regular adherence. One published survey noted patients tended to prefer OMIT over SCIT when offered the choice [2]. Another study demonstrated a trend toward increased adherence with OMIT compared to SLIT [1]. Also, allergy shots have a small risk of triggering serious reactions, and therefore should be administered in a clinical setting. To minimize risk, the extract in allergy shots must be titrated up weekly over 6-9 months just to reach the maintenance level. This dose escalation phase may prolong the time until symptom reduction. However, OMIT treatment can generally initiate at maintenance doses of extract allowing patients to have a reduction in symptoms much sooner. The Allerdent's higher adherence rate in comparison to SCIT or SLIT gives you a much higher chance of successfully treating allergies.
  14. 13
    Is there research on OMIT (oral mucosal immunotherapy)?
    OMIT is essentially an improvement of SLIT (Sublingual Immunotherapy using drops under the tongue). There are hundreds of peer-reviewed publications about SLIT. Some reviews of data from multiple SLIT studies have concluded that SLIT is safe and effective. [3,4,5,6] Another study compared OMIT to SLIT, and showed that OMIT can improve quality of life and decrease symptoms and medication use while also promoting excellent adherence and minimal side effects. [1]
  15. 14
    What if there are "regional" allergies that are not listed on the test? How are they addressed?
    The finger stick IgE test targets a comprehensive sampling of airborne allergens from a variety of regions, so this situation should be very rare. In fact, there may be several regional allergens on the panel, particularly pollens, which are not present in the area where a patient resides. Another key regional variance is within a closely related species within one genus or family of allergens. For example, there are over 60 different oaks that occur in the US, but only a few are available as allergenic extracts. But that's fine, because allergens from different Oak trees cross-react highly in different patients due to genetic similarity. However, if there is a need to test a patient for a particular allergen that is not on the panel or not related to any allergens on the panel, separate testing can be arranged.
  16. 15
    Does OMIT based toothpaste with Allerdent® treat food allergies?
    No – the finger stick blood test using only 10 drops of blood does test for 50 food allergens, but the Allerdent® toothpaste only contains allergens for airborne or non-food allergies. Currently, the standard of care for food based allergies is avoidance of specific foods at this time.
  17. 16
    Is this a vaccine or an immunization?
    It is analogous to a vaccine in that it stimulates cells in the body to protect against potential allergic reactions from future exposures. However, as opposed to other vaccines, the toothpaste does not contain proteins that come from viruses or bacteria. The serum antigens used in Allerdent® are from a biological source, completely natural and with an excellent safety profile.
  18. 18
    Does insurance cover Allerdent®? If so, is there a co-pay or deductible?
    No. The reason is that the allergens are used off label (just as in standard practice for SLIT). Having said this, most health plans have a $20 - $50 office visit copay, so in order to receive weekly on label allergy shots, it can cost a patient $80 - $200 monthly in out of pocket costs. Allerdent® costs around $88 a month, and patients can apply the cost to health savings accounts (HSA, Flex-Spending).
  19. 19
    Can I travel with Allerdent®?
    Yes. Since the toothpaste is stable and only needs to be kept at room temperature, you can take it with you on a plane, to summer camp, vacations, college, etc. When you are away from home, we can have the compound pharmacy mail your refills to where you are temporarily out of the area.
  20. 19
    Can a healthcare provider use only the fingerstick molecular proteomic test results to make the diagnosis of a food or environmental allergy for a patient?
    No, as it is very important to always include a patient’s medical, family history and physical examination in the context of appropriate allergy confirmatory testing, such as the fingerstick test, done with only 5 drops of blood. This is the same for food or environmental allergies in the evaluation of patients with allergies and asthma (approximately 90% of all asthmatics have allergies as a triggering event). All our fingerstick test reports say that the report alone is not a diagnosis and a diagnosis of allergies is only made by a clinician in conjunction with a physical examination and medical history.
PHYSICIAN ASKED QUESTIONS
  1. 0
    My patient has sensitivities to practically all of the allergens tested. How do I decide which to put in the treatment pump?
    While only non-food based allergens diagnosed in the finger stick test go in the treatment pump, it is usually not necessary to put all of the positive allergens in. Based on the patient’s history, pick some of the most clinically-relevant non-food based allergens, keeping in mind that the higher levels of sensitivity are more likely to be the ones causing symptoms. If all of the allergens tested are high grade, consider having that patient see an allergist/immunologist before starting them on Allerdent®.
  2. 1
    What is the ideal number of non-food allergens to include in the treatment pump?
    There is no research currently that has clearly answered that question. Including too few extracts may miss some important sensitivities, while including too many may create competition for the available immune cells in the oral cavity mucosa. The ideal number is individualized for each patient, based on their history and sensitivities diagnosed from the finger stick test.
  3. 2
    Can patients continue Allerdent® if they become pregnant?
    If your patient is already pregnant, do not start them on Allerdent®. However, if they become pregnant while on Allerdent®, there is no need to stop therapy.
  4. 3
    It really seems like my patient has allergies, but all the testing came back negative. Could they still be allergic?
    There is a chance that specific IgE is present in a symptomatic area, such as the nose, but not at detectable levels in the blood. Your patient may also be reacting to non-allergic irritants in the air, such as chemicals, odors, pollution, particles or fluctuations in temperature or humidity. Mold spores in the air can also cause allergy-like symptoms, even if mold sensitivity is not detected via blood testing. Remember to ask about recent water leaks, renovations, or strange odors indoors.
  5. 4
    How long should it take for my patient to start feeling better?
    Typically, symptom relief and decreased need for medications begins within months into therapy using Allerdent®. It is important to stress to your patient that they need to continue the full 3 – 5 years of consistent, daily self-administration, busing their teeth for only 2 minutes a day, to hold on to those benefits after stopping therapy.
  6. 5
    It’s been a year since my patient started Allerdent® but they are still not feeling any better. Should I continue therapy?
    It is important to see your patient regularly in the office to monitor their progress on Allerdent®. If they are not noticing any improvements by that point, go over their history again and see if any other allergens should be added or doses of current allergens increased. If the prescription is modified a year into therapy, it may be best to continue the course of Allerdent® for 5 years.
  7. 6
    Once the prescription for Allerdent® has been made, is it possible to change it?
    Yes, non-food allergens can be added or removed and the dosage can be increased or decreased if needed. There is no requirement that all allergens must be administered at the same dose.
  8. 7
    Do I need to prescribe an EpiPen® for patients receiving Allerdent®?
    Because allergens are brought to the immune system passively, and at a steadier rate, via immune cells in the oral cavity in comparison to allergy shots, the therapy is safe enough to be administered at home. This level of safety has been demonstrated particularly for SLIT, which is related to OMIT [6]. Even though the risk of severe, systemic allergic reactions is extremely small, it’s never the wrong decision to give a prescription for an EpiPen®. It is estimated that about half of OMIT prescribers are giving their patients prescriptions for an EpiPen®.
  9. 8
    Can my patient still use allergy medications while on Allerdent®?
    Yes - allergy medications, such as antihistamines or nasal steroid sprays, will not interfere with Allerdent®. However, your patient should notice that they are using less medications as they continue on OMIT and that the medications are more effective when used.
  10. 9
    How does the effectiveness of OMIT compare to other methods of desensitization?
    There have been no head to head studies comparing OMIT with allergy shots. However, a recently published study demonstrated similar improvements in quality of life along with reductions in symptoms and medication use after 1 year between OMIT and sublingual drops (SLIT) [1].
  11. 10
    During the first week of Allerdent®, my patient called and reported some itching and tingling in the gums and lips. Is this normal?
    About 30-40% of patients will experience some mild, transient itching, tingling or swelling around the lips, tongue and gingiva during the first week or two of therapy. If it is uncomfortable for the patient, the clinician may consider dropping the dose to 1 pump daily for 2 weeks, then resuming the normal daily dose of 2 pumps.
  12. 11
    Do adults and children use the same daily dose of Allerdent®?
    Yes - the dose for both adults and children is 2 pumps daily either given as 1 pump twice daily or 2 pumps once daily. If the clinician desires, they may start young children at 1 pump daily for the first couple of weeks, then escalating to the regular daily dose.
  13. 12
    My patient has another toothpaste that they would really like to keep using. Is that possible?
    Yes - simply have your patient use their OMIT toothpaste once a day (two metered pumps) and then brush their teeth with normal toothpaste at other times during the day.
  14. 13
    Is it OK for my patient to rinse with mouthwash after using their Allerdent® toothpaste?
    If your patient wants to use mouthwash, have them use it before brushing with their Allerdent® toothpaste instead of after. It is fine for them to rinse out with regular water after brushing.
  15. 14
    What is the youngest age you would consider putting a child on Allerdent®?
    At this point, there is no research to guide a cutoff point for the youngest eligible age, though immunotherapy is generally considered for children once they reach school age. Research has demonstrated that young children benefit greatly from starting immunotherapy early because it can prevent further sensitization and the development of asthma.
  16. 15
    My patient has stated that they have difficulty brushing for the full 2 minutes. What can I tell them?
    Two minutes can be monitored by a smartphone’s stopwatch, a second hand on a regular watch or even commonly available toothbrushes that can play a song for 2 minutes. If your patient cannot keep brushing for the full 2 minutes, have them brush for as long as they can, but avoid spitting out the foam until 2 minutes has been reached.
  17. 16
    Is it important for my patient to do the first brushing in the office?
    It is recommended that the first brushing of the therapy is performed in the physician’s office, both to verify adequate brushing technique as well as to evaluate for any adverse reactions. During the brushing, the patient should be encouraged to keep as much of the foam in the mouth until 2 minutes has been reached. The patient is then observed for an additional 20 minutes and the inside of the mouth examined for any areas of redness or swelling.
  18. 17
    Should my patient on OMIT avoid therapy after dental work, and when can they resume therapy?
    Allerdent® does not have to be suspended for minor dental work such as cleanings and fillings. However, if incisions are going to be made in the gum or more extensive work is necessary (such as extractions or root canal) it is recommended to suspend Allerdent® for one week.
  19. 18
    Can my patient continue Allerdent® if they are sick?
    If your patient has a mild illness without fever, it is OK to continue Allerdent®. However, if they have a fever and feel sick enough to miss school or work, Allerdent® should be suspended until they are feeling better.
  20. 19
    Can my patient eat and drink around the time they are using Allerdent®?
    There is no research which has examined the impact of eating and drinking in the immediate period around brushing during Allerdent®. However, the normal level of mouth saliva is necessary for the allergens to be absorbed, so it is recommended to avoid eating or drinking about 15 minutes before and after brushing.
  21. 20
    Is Allerdent® FDA approved?
    The allergy extracts that are used for Allerdent® are FDA-approved for injection, one extract per injection, underneath the skin (subcutaneous) for the purpose of allergy desensitization. Different extracts may be mixed together in specific combinations and, in addition, may be administered without needles (i.e. to the mucosal lining of the mouth). This is termed off label usage of extracts and is common for a wide variety of medications. When a medication is used in an off label fashion, insurance companies may not reimburse it. However, a lack of FDA approval does not mean that a medication is ineffective, unsafe, or hasn’t been studied. Many medications in cardiology are used off label based on peer reviewed accepted medical literature.
  22. 21
    Will this program impact my relationship with allergists?
    Yes, in a positive way! Currently, 95% of patients do not see an allergist and do not receive treatment; they only mask symptoms with OTC medications. Only 5% of the worst case/food allergic patients spend the time receiving treatment from allergists. Now, you can test your patients in your office. If they are one of the 95%, you can also treat them by brushing their teeth. However, if they have multiple allergies and rate high on the finger stick test, you can refer them to the allergist (with the test result in hand) and provide the allergist with information which historically they have not had.
  23. 22
    Can a healthcare provider use only the fingerstick molecular proteomic test results to make the diagnosis of a food or environmental allergy for a patient?
    No, as it is very important to always include a patient’s medical, family history and physical examination in the context of appropriate allergy confirmatory testing, such as the fingerstick test, done with only 5 drops of blood. This is the same for food or environmental allergies in the evaluation of patients with allergies and asthma (approximately 90% of all asthmatics have allergies as a triggering event). All our fingerstick test reports say that the report alone is not a diagnosis and a diagnosis of allergies is only made by a clinician in conjunction with a physical examination and medical history.
REFERENCES
     ​​
  1. Reisacher WR, Suurna MV, Rochlin K, Bremberg MG, Tropper G. Oral mucosal immunotherapy for allergic rhinitis: A pilot study. Allergy Rhinol (Providence). 2016 Jan;7(1):21-8.
  2. Chester JG, Bremberg MG, Reisacher WR. Patient preferences for route of allergy immunotherapy: a comparison of four delivery methods. Int Forum Allergy Rhinol. 2016 May;6(5):454-9.
  3. Radulovic S, Wilson D, Calderon M, Durham S. Systematic reviews of sublingual immunotherapy (SLIT). Allergy. 2011 Jun;66(6):740-52.
  4. Kim JM, Lin SY, Suarez-Cuervo C, Chelladurai Y, Ramanathan M, Segal JB, Erekosima N. Allergen-specific immunotherapy for pediatric asthma and rhinoconjunctivitis: a systematic review. Pediatrics. 2013 Jun;131(6):1155-67.
  5. Lin SY, Erekosima N, Suarez-Cuervo C, et al. Allergen-Specific Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and/or Asthma: Comparative Effectiveness Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Mar. (Comparative Effectiveness Reviews, No. 111.) Available from: https://www.ncbi.nlm.nih.gov/books/NBK133240/
  6. Canonica GW, Cox L, Pawankar R, et al. Sublingual immunotherapy: World Allergy Organization position paper 2013 update. The World Allergy Organization Journal. 2014;7(1):6. doi:10.1186/1939-4551-7-6.
 
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