What is ARESTIN® (minocycline HCl) 1 mg Microspheres?
ARESTIN® is an effective antibiotic treatment that comes in powder form. This powder is placed inside infected periodontal pockets just after the dental professional finishes the scaling and root planing (SRP) procedure.
How does ARESTIN® work?
ARESTIN® powder contains "Microspheres," which are tiny, bead-like particles that are smaller than grains of sand and are not visible to the eye. The Microspheres are filled with the antibiotic minocycline, and they release the drug over time into the infected periodontal pocket, killing bacteria that live there.
ARESTIN® is proven in clinical studies.
ARESTIN® Microspheres continue to fight the infection for up to 21 days after SRP. In clinical studies, ARESTIN® has been proven to be more effective than using SRP alone. ARESTIN® also significantly reduced the size of periodontal pockets compared to SRP alone.
Periodontal Disease and ARESTIN®: Frequently Asked Questions
The following questions and answers should help you understand periodontal disease and treatment with scaling and root planing (SRP) + ARESTIN® (minocycline HCl) 1 mg Microspheres.
Q. What is adult periodontitis?
A. Adult periodontitis is a bacterial infection causing destruction of tissue and bone around your teeth and can lead to tooth loss.
Q. What is periodontal disease?
A. Periodontal disease is a bacterial infection leading to damage to the gums, tissues and bone around your teeth. The destruction of tissue and bone causes "pockets" around teeth and can lead to tooth loss. With proper treatment, patients have a better chance of saving their teeth and controlling further disease progression.
Q. What is scaling and root planing?
A. Scaling and root planing is a non-surgical procedure performed by a dental professional. It involves a deep cleaning above and below the gum line to remove plaque that builds on the teeth.
Q. Why would you use an antibiotic to treat Periodontal disease?
A. Periodontal disease is caused by a bacterial infection, and so the use of an antibiotic is an important part of controlling the disease in addition to a mechanical procedure called scaling and root planing. The antibiotic helps to stop the bacteria which causes periodontal disease.
How do I know if I'm at risk for Periodontal disease?
A. There are a number of important factors that may put someone at risk for periodontal disease. It is important to talk to your dental professional about your specific risk factors. One important factor that can lead to Periodontal disease is inadequate oral hygiene. Brushing, flossing regularly and regular dental cleanings help prevent plaque buildup and therefore help guard against Periodontal disease.
Q. Are there other factors that may contribute to Periodontal disease?
A. There are a number of important factors that may contribute to Periodontal disease. These factors may or may not include: a genetic predisposition, some prescription medications, diabetes, pregnancy, stress, smoking, grinding or clenching teeth, poor nutrition, diseases that affect your immune system and tooth irregularities.
Q. How should I take proper care of my mouth to maintain good oral health?
A. Good brushing and flossing habits are vital to strong oral health, however, regular dental check-ups are the leading way to prevent and treat more serious oral infections.
Q. Are there any Internet websites where I can receive additional information regarding oral health?
A. Yes. Please check out the internet websites for the following organizations: The American Dental Association (www.ada.org), The American Academy of Periodontology (www.perio.org), The American Dental Hygienist Association (www.adha.org), and/or The Academy of General Dentistry (www.agd.org).
Q. What is ARESTIN®?
A. ARESTIN® is a prescription product approved by the Food and Drug Administration (FDA). It is used together with scaling and root planing procedures performed by a trained dental professional for the treatment of adult periodontitis.
Q. What is the active ingredient in ARESTIN®?
A. The active ingredient in ARESTIN® is an antibiotic called minocycline. It is available as a powder-like substance using a microsphere technology.
Q. What are ARESTIN® microspheres?
A. Although the microspheres are not visible, if you could see them, these microspheres are tiny, round, dry-powder beads of different sizes, which contain the active ingredient, minocycline. This technology allows extended release of the minocycline to effectively stop the germs or bacteria that cause periodontal disease.
Q. When is ARESTIN® used?
A. ARESTIN® is used together with scaling and root planing procedures performed by a trained dental professional. Treating periodontal disease with ARESTIN® and scaling and root planing may help you manage adult periodontitis more effectively than scaling and root planing alone.
Q. How does ARESTIN® work?
A. ARESTIN® uses microsphere technology to deliver minocycline, a potent antibiotic in a low dose that kills the bacteria that causes periodontal disease. The active agent, minocycline, is placed painlessly under the gums, directly to the infected site.
Q. Who can benefit from treatment with ARESTIN®?
A. Many patients with periodontal disease can benefit from ARESTIN®. However, ARESTIN® should not be used in any patient who has a known allergy or sensitivity to minocycline or tetracycline. In addition, ARESTIN® should not be used in children or in patients who are pregnant or nursing a baby.
The use of ARESTIN® in an acutely abscessed periodontal pocket has not been studied and is not recommended. While no overgrowth by opportunisitic microorganisms, such as yeast, were noted during clinical studies, as with other antimicrobials, the use of ARESTIN® may result in overgrowth of nonsusceptible microorganisms including fungi. The effects of treatment for greater than 6 months has not been studied. ARESTIN® should be used with caution in patients having a history of predisposition to oral candidiasis. ARESTIN® has not been clinically tested in immunocompromised patients (such as those immunocompromised by diabetes, chemotherapy, radiation therapy, or infection with HIV). If superinfection is suspected, appropriate measures should be taken.
ARESTIN® has not been clinically tested for use in the regeneration of alveolar bone, either in preparation for or in conjunction with the placement of endosseous (dental) implants or in the treatment of failing implants.
Q. How do I achieve the best results from my treatment with ARESTIN®?
A. To achieve the best results, follow the instructions given by your dental professional.
You'll also find these important guidelines useful after treatment with ARESTIN®:
- Avoid touching treated areas
- Resume your normal brushing routine 12 hours after treatment
- Wait 10 days before using floss, toothpicks, or other devices designed to clean between teeth
- Resume practice of good oral hygiene, brushing 3 times a day and flossing daily
- For 1 week, avoid foods that could hurt your gums
- Be sure to return for your follow-up appointments, since gum disease can recur and needs to be checked regularly
Q. Is treatment with ARESTIN® a new procedure?
A. The use of a locally administered antibiotic (LAA) is not a new concept. For years, dentists have used antibiotics in conjunction with SRP procedures. However, ARESTIN® is the first LAA with Microspheres that has been proven to be more effective than SRP alone.
What kind of side effects were observed in ARESTIN® clinical trials?
Minimal side effects were reported in clinical studies, and those that were reported were similar to placebo (no treatment at all). In key clinical trials, the most common adverse events associated with treatment were headache (9.0%), infection (7.6%), flu syndrome (5.0%), and pain (4.3%).
Q. If my dental professional is already using scaling and root planing to treat my periodontal disease, can ARESTIN® help?
A. Yes. ARESTIN® used in combination with scaling and root planing is more effective at fighting periodontal disease than scaling and root planing alone. ARESTIN® is placed directly into the infected site and can stop the bacteria, which cause the disease.
Q. Was ARESTIN® tested in clinical studies?
A. ARESTIN® was studied in over 400 adult patients with periodontal disease in three multicenter clinical research trials in the United States. These clinical research studies allowed for the collection of data establishing the safety and effectiveness of ARESTIN®.
Q. How can ARESTIN help periodontal disease?
A. When used together with scaling and root planing, ARESTIN® can significantly reduce the depth of the infected pockets that can form around teeth and help prevent disease progression. The combination of ARESTIN® and scaling and root planing is more effective at fighting periodontal disease than scaling and root planing alone. In addition, ARESTIN has been shown to be particularly effective in patients who are smokers.
Q. What do I need to know after I am treated with ARESTIN® ?
A. After treatment, you should avoid eating hard, crunchy, or sticky foods for one week and postpone brushing for a 12-hour period, as well as touching treated areas. You should also postpone the use of interproximal cleaning devices, such as dental floss, dental tape, toothpicks, etc. for ten days after administration of ARESTIN®. Some mild to moderate sensitivity is expected during the first week after scaling and root planing and administration of ARESTIN® , you should notify your dentist promptly if pain, swelling or other problems occur. To maximize the results of your ARESTIN® treatment, speak with your dental professional and follow the above recommendations.
Q. How long does treatment with ARESTIN® take?
A. Treatment time for placement of ARESTIN® depends on the number of affected periodontal pocket sites, but generally the procedure is relatively fast, easy and comfortable.
A. Treatment with ARESTIN® is easy and doesn't cause discomfort. There is no need for anesthesia or use of needles when ARESTIN® is applied.
Q. What does ARESTIN® taste like?
A. ARESTIN® powder has no taste.
A. No. ARESTIN® is naturally absorbed into the gums, leaving nothing that needs to be removed by your dentist.
A. No. ARESTIN® does not require bandages and won't leak or fall out.
A. Patients treated with ARESTIN® may experience side effects. The most frequent non-dental adverse experiences reported in clinical research trials were headache, infection, flu syndrome, and pain. The most frequent dental treatment-emergent adverse experiences were inflammation of the gums, tooth disorder, tooth caries (cavities), and dental pain. In the clinical research trials, ARESTIN® did not alter taste, stain teeth, or cause upset stomach. Some mild to moderate sensitivity may occur in the first week after scaling and root planing and administration of ARESTIN®. Please notify your dental professional promptly if pain, swelling or other problems occur.
Q. Are there any drug interactions with ARESTIN®?
A. Interactions with ARESTIN® and other drugs have not been studied. We recommend that you consult your physician about any health concerns or conditions you may have, as your physician is familiar with you and your personal medical history.
Q. Can I receive ARESTIN® if I am allergic to minocycline or tetracycline?
A. ARESTIN® should not be used in any patient who has a known allergy or sensitivity to minocycline or tetracycline. To follow good medical practice you should consult with your physician about any health concerns or conditions you may have, as your physician is familiar with you and your personal medical history.
Q. Will ARESTIN® interact with the penicillin I take prior to my dental work?
A. An interaction with ARESTIN® and penicillin has not been studied. We recommend that you consult your physician and/or dentist about any health concerns you may have, as they are familiar with you and your personal medical history.
Q. Can I receive ARESTIN® if I am pregnant or nursing a baby?
A. No. ARESTIN® should not be used if you are pregnant or nursing a baby. You should consult your physician about any health concerns you may have, as your physician is familiar with you and your personal medical history.
Q. What if I am pregnant or nursing a baby and received ARESTIN®?
A. The use of ARESTIN® in pregnant or nursing women has not been studied. We recommend you consult your physician about any health concerns or conditions you may have, as your physician is familiar with you and your personal medical history.
Q. If I have an allergic reaction to either gluten, red or yellow dye or nuts, can I still receive ARESTIN®?
A. Yes, ARESTIN® does contain any gluten, red or yellow dye or nuts or nut by-products.
A. The cost of ARESTIN® varies depending on how much treatment you need. After your dental professional has evaluated your oral health and discussed treatment options, he or she can provide you with an estimate of the cost. Keep in mind that treating periodontal disease today is less costly and better for your health than waiting to treat symptoms at a more advanced stage.