FREQUENTLY ASKED QUESTIONS

PATIENT
ASKED
QUESTIONS
  1. 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. However, the patient can be tested at any age from infants to adults.
  2. 2
    Is there an age limit for the testing and/or immunotherapy treatment?
    No - Both the finger stick test and the OMIT treatment can be recommended at any age when it is necessary.
  3. 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]
  4. 3
    Are there any side effects and will they be "published" for the patients?
    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. It is up to the doctor to monitor their patients’ progress and publish their findings, results, or unusual side effects.
  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 yet been reported. But if they occur, the physician should consider decreasing the dose of OMIT or holding the therapy until the sores heal.
  6. 6
    Can OMIT using Allerdent® replace normal toothpaste?
    Yes - It is a fully functional toothpaste that will clean your teeth. OMIT contains same ingredients as are used in standard toothpastes. Fluoride may be added per the healthcare provider's discretion. OMIT behaves, tastes, and smells like standard toothpastes. Berry and mint flavored OMIT are currently available. Since the dosing with Allerdent is generally recommended to be only once per day, patients can use their own brand of toothpaste at other brushings.
  7. 6
    Is OMIT safe?
    OMIT has been designed as a related alternative to SLIT with important benefits for the patient. There are a great number of published studies and analyses of SLIT which generally conclude that, when used correctly and under proper medical supervision, immunotherapy extracts applied to the oral cavity are very safe and can be self-administered by patients at home. Future clinical research will focus on the specific safety of OMIT. However, a doctor who considers offering SLIT might review the safety data of SLIT while being mindful of the similarities and differences between SLIT and OMIT. A study comparing OMIT to SLIT suggests that OMIT safety is on par with that of SLIT.
  8. 8
    What happens if anyone uses the toothpaste other than the patient?
    No harm, other than wasting prescribed toothpaste. They will simply receive some allergens to which they are likely not allergic. Allerdent toothpaste cannot induce an allergy in a patient with no history of allergies to the compounds in the toothpaste.
  9. 9
    What is in the Allerdent® toothpaste?
    In addition to the regular toothpaste ingredients, Allerdent® contains the natural allergen proteins that are driving the patient’s symptoms and have thus been prescribed by the healthcare provider to treat the non-food allergies identified in the blood test. Fluoride may be added per the healthcare provider's discretion.
  10. 9
    Is the toothpaste FDA approved?
    The allergy extracts that are used for OMIT 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.
  11. 10
    Is there a limit on how long I can use the toothpaste?
    Most immunotherapy regimens take 3-5 years. Under supervision of a medical professional, a longer treatment regimen may be possible.
  12. 11
    When will I see results?
    As with other allergy immunotherapy treatments, many patients on OMIT 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.
  13. 13
    Can I build up a tolerance to OMIT, 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 OMIT are therefore known as “disease modifying” therapies. Conversely, antihistamines 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.
  14. 13
    Why is 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.
  15. 15
    Is there research on Allerdent (OMIT)?
    OMIT is essentially an improvement of SLIT. And 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]
  16. 16
    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. 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 Oaks cross-react highly in different patients due to phylogenetic 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.
  17. 17
    Does OMIT toothpaste treat food allergies?
    No – the blood test does test for 67 food allergens, but the toothpaste only contains allergens for airborne or environmental non-food allergies.
  18. 17
    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 antigens are from a biological source, completely natural and with an excellent safety profile.
  19. 19
    Does insurance cover OMIT (toothpaste)? 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. OMIT costs around $88 a month, and patients can apply the cost to health savings accounts (HSA, Flex-Spending).
  20. 20
    Can I travel with OMIT (toothpaste)?
    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, the compound pharmacy can mail your refills to where you are temporarily out of the area. Allerdent toothpaste is TSA compliant.
  21. 21
    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 secondary asthma (approximately 90% of all asthmatics have allergies as a triggering event). All of the fingerstick test reports state 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. 2
    What is the ideal number of 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. Currently, a maximum of 10 serum allergens may be added to each individualized prescription.
  2. 2
    Can patients continue OMIT if they become pregnant?
    If your patient is already pregnant, do not start them on OMIT. However, if they become pregnant while on OMIT, there is no need to stop therapy.
  3. 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 positive allergens 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 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 OMIT.
  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. It is important to stress to your patient that they need to continue the full 3 – 5 years of consistent, daily self-administration to hold on to those benefits after stopping therapy.
  6. 5
    It’s been a year since my patient started OMIT, 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 OMIT. 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 OMIT for 5 years.
  7. 6
    Once the prescription for OMIT has been made, is it possible to change it?
    Yes, 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 OMIT?
    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 OMIT?
    Yes - allergy medications, such as antihistamines or nasal steroid sprays, will not interfere with OMIT. 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 OMIT, 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?
    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 OMIT toothpaste?
    If your patient wants to use mouthwash, have them use it before brushing with their OMIT toothpaste instead of after. It is fine for them to rinse out with regular water after brushing.
  15. 15
    What is the youngest age you would consider putting a patient on OMIT?
    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 secondary 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?
    OMIT 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 OMIT for one week.
  19. 18
    Can my patient continue OMIT if they are sick?
    If your patient has a mild illness without fever, it is OK to continue OMIT. However, if they have a fever and feel sick enough to miss school or work, OMIT should be suspended until they are feeling better.
  20. 19
    Can my patient eat and drink around the time they are using OMIT?
    There is no research which has examined the impact of eating and drinking in the immediate period around brushing during OMIT. 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 the toothpaste FDA approved?
    The allergy extracts that are used for OMIT 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.
  22. 22
    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 test (ex. classification 9-10), 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. 23
    Does a patient need to stop any anti-allergy and anti-asthma medications before fingerstick blood testing?
    No – Discontinuation of any anti-allergy and anti-asthma medications is not required prior to the administration of the fingerstick blood test. Specific measurements of IgE related subsets is not dependent on the use of these medications, unlike a scratch test.
  24. 24
    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.