New assay to study the reduction of certain pathogens after the scaling and root planing procedure
LAVAL, Quebec, May 18, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) and its oral health business, OraPharma, today announced the publication of a new study, which showed that ARESTIN®(minocycline HCI), 1mg decreased certain pathogenic burdens, also known as infection burdens, in adults with periodontitis when applied immediately after scaling and root planing (SRP) and again at a three-month reapplication, versus SRP alone. ARESTIN is an FDA-approved antibiotic applied locally to pockets of gums in adults with periodontitis after an SRP procedure and is used as part of an overall oral health program. ARESTIN should not be used in people who are allergic to minocycline or tetracyclines.
The investigator-initiated study, sponsored in part by Bausch Health and conducted by researchers at the University of Minnesota School of Dentistry, appeared today in theJournal of Periodontology.The study showed that application of minocycline immediately after the initial SRP and reapplication 3 months after the SRP decreased certain major pathogens and may have contributed to improvements in probing depth (PD), clinical attachment loss (CAL), bleeding on probing (BOP) and gingival index (GI) compared with SRP alone.
“Dental practices need to think about periodontal disease and the role of major pathogens that originate in the mouth, can travel, and can be associated with other systemic outcomes such as diabetes and cardiovascular disease,” said Richard Nagelberg, DDS, Director of Medical Affairs at Bausch Health. "This study represents an important avenue to help manage periodontal disease and we hope it will encourage further research in the area of periodontal disease progression and how it may relate to the oral-systemic connection."
Since the pivotal trial, there has been a gap in the literature regarding whether minocycline HCI microspheres, 1mg reduced specific periodontal pathogens. This study identified that the administration of minocycline HCI microspheres, 1mg, significantly decreased specific periodontal pathogens.
The aim of the study entitled,Effect of scaling and root planing with and without minocycline HCl microspheres on periodontal pathogens and clinical outcomes: a randomized clinical trial,was to determine whether minocycline HCl plus SRP contributed to the improvement of certain clinical measures commonly seen in patients with gum disease. A secondary objective was to determine whether minocycline HCl microspheres with SRP reduced specific pathogens responsible for periodontitis compared to SRP alone. Saliva and clinical outcomes were collected for both groups at baseline before the SRP, 1-month reassessment, and 3- and 6-month periodontal assessments. Minocycline microspheres (MM) were placed in pockets ≥ 5 mm immediately after the SRP and immediately after the 3-month periodontal maintenance. This study reported that of 11 pathogens that play an instrumental role in periodontitis, there were six periodontal pathogens that had a statistically significant decrease at 1 month and four periodontal pathogens with a statistically significant decrease in periodontal maintenance at 6 months versus the SRP group alone. This study also reported that minocycline HCI plus SRP achieved greater improvement for probing depth, bleeding on probing, gingival index, and improvement in clinical attachment loss by six-month periodontal maintenance versus SRP alone.
Study limitations include the lack of an examiner blinded to clinical outcomes and the lack of patient-reported outcome measures. The principal investigator (PI) collected saliva, recorded clinical measurements, and provided treatment for both groups. Participants in this study were predominantly from the Midwest region, Caucasian and over the age of 50 years, which does not represent the general population of individuals with periodontitis.
"There was a greater decrease in Tannerella forsythia, Treponema denticola, Fusobacterium nucleatum/periodonticum, Prevotella intermedia, Parvimonas micra, and Eikenella corrodens in the SRP+MM group," said Dr. Nagelberg. It is notable that minocycline HCl microspheres, 1 mg immediately after SRP procedures, reduced these specific periodontal pathogens at the 1-month reassessment.
The previous pivotal study (Williams et al., 2001) was conducted to determine whether minocycline HCI plus SRP reduced pocket depth in patients with moderate to advanced generalized adult periodontitis versus SRP alone. Subjects treated with minocycline HCI plus SRP were found to have statistically significantly reduced probing depth compared to those treated with SRP alone or SRP + vehicle 9 months after initial treatment.
about the study
A total of 70 participants were randomized to receive SRP alone, or SRP with minocycline HCl microspheres, 1mg after the procedure and again at the 3-month periodontal visit. Participants in both groups received periodontal assessments at baseline, one month, three months, and six months after the initial SRP procedure. The primary objective of this study was to determine the adjuvant effects of minocycline microspheres (MM) on clinical outcomes of PD, CAL, BOP, and GI after SRP+MM compared to SRP alone. Secondary outcome variables were the relative numbers of 11 periodontal pathogens in saliva after SRP+MM compared to SRP alone. Bacterial load and pathogenic load were determined using a salivary test.
Microorganisms and secondary periodontal measurements were compared between groups using generalized linear mixed-effects models, with fixed effects for group, visit, site (for clinical measurements), and group-by-visit and group-by-site interactions, and random effects for participant and site within the group. participant. Mean changes from baseline were compared between groups using group-per-visit interaction tests.
The six periodontal pathogens observed in the test group to have a statistically significant decrease compared with the SRP group alone at the one-month follow-up visit wereTannerella forsythia (Tf)(0,003),treponema denticola(Td)(0,01),Fusobacterium nucleatum/periodonticum (Fn/Fp)(0,0009), Prevotella intermedia (Pi)(0,04),Parvimonas micra (Pm)(<0,0001),eEikenella corrodens (Ec)(0.02). Furthermore, the four periodontal pathogens observed in the test group to have a statistically significant decrease compared to the SRP group alone at the last six-month visit wereFusobacterium nucleatum/periodonticum (Fn/Fp)(0,02),Prevotella intermedia(0,05),Campylobacter rectus (Cr)(0,04) eEikenella corrodens(0,0002).
Study limitations include the lack of an examiner blinded to clinical outcomes and the lack of patient-reported outcome measures. The principal investigator (collected saliva, recorded clinical measurements, and provided treatment for both groups. Participants in this study were predominantly Midwest, Caucasian, and older than 50 years, which does not represent the general population of individuals with periodontitis .
Statistical analysis for this research was supported by a grant from the National Institutes of Health’s National Center for Advancing Translational Science.
Important safety information for ARESTIN®
RECOMMENDATION
ARESTIN® (minocycline HCl) Microspheres, 1 mg is indicated as an adjunct to scaling and root planing (SRP) to reduce pocket depth in patients with adult periodontitis. ARESTIN can be used as part of a periodontal maintenance program that includes good oral hygiene and SRP.
IMPORTANT SAFETY INFORMATION
ARESTIN is contraindicated in any patient who has a known sensitivity to minocycline or tetracyclines. Hypersensitivity reactions and hypersensitivity syndrome including, but not limited to, anaphylaxis, anaphylactoid reaction, angioedema, urticaria, rash, eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis may be present. Swelling of the face, pruritus, fever and lymphadenopathy have been reported with the use of ARESTIN. Some of these reactions were severe. Post-marketing cases of anaphylaxis and severe skin reactions such as Stevens Johnson syndrome and erythema multiforme have been reported with oral minocycline, as well as acute photosensitivity reactions.
THE USE OF TETRACYCLINE CLASS DRUGS DURING DENTAL DEVELOPMENT MAY CAUSE PERMANENT BREACH OF THE TEETH, THEREFORE THEY SHOULD NOT BE USED IN CHILDREN OR PREGNANT WOMEN OR INFANTS.
Tetracyclines, including oral minocycline, have been associated with the development of autoimmune syndromes, including a lupus-like syndrome manifested by arthralgia, myalgia, rash, and swelling. Sporadic cases of serum sickness-like reaction have presented shortly after oral use of minocycline, manifested by fever, rash, arthralgia, lymphadenopathy, and malaise. In symptomatic patients, diagnostic tests should be performed and treatment with ARESTIN discontinued.
The use of ARESTIN in an acute abscess periodontal pocket or for use in alveolar bone regeneration has not been studied.
The safety and efficacy of ARESTIN have not been established in immunocompromised patients or those with coexisting oral candidiasis. Use with caution if predisposed to oral thrush.
In clinical trials, the most frequently reported non-dental adverse events were headache, infection, flu-like illness, and pain.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
Cliqueherefor complete prescribing information.
About ARESTIN
ARESTIN® is an FDA approved antibiotic applied locally to pockets of gums in adults with periodontitis after an SRP procedure and is used as part of an overall oral health program. ARESTIN should not be used in people who are allergic to minocycline or tetracyclines.
In 2001, a pivotal study was performed to: 1) determine whether administration of minocycline microspheres would enhance the therapeutic effect of scaling and root planing in patients with chronic periodontitis and 2) determine whether the compound was safe and well tolerated.
Seven hundred forty-eight (748) patients with moderate to advanced periodontitis were enrolled in a multicenter study, investigator-blinded and randomized to 1 of 3 treatment arms: 1) scaling and root planing (SRP) alone; 2) SRP plus vehicle; or 3) SRP plus minocycline microspheres. The primary outcome was reduction in probing depth at 9 months. Clinical assessments were performed at baseline and 1, 3, 6, and 9 months.
Minocycline microspheres plus scaling and root planing provided substantially more reduction in probing depth than SRP alone or SRP plus vehicle. The difference reached statistical significance after the first month and was maintained throughout the trial. It was observed that the improved outcome was independent of the patients' smoking status, age, sex or baseline disease level. There was no difference in the incidence of adverse effects between treatment groups.
About the risks of periodontitis
According to the National Health and Nutrition Survey (NHANES), 42.2% of US adults have periodontitis. There are certain factors that increase your risk of developing gum disease such as smoking, diabetes, poor oral hygiene, obesity and diabetes. Additionally, gum disease can provide a gateway for bacteria to enter the body and trigger systemic health issues and inflammation in the body, although more research is needed.
About OraPharma
OraPharma is a specialty pharmaceutical company committed to partnering with dental professionals to improve oral health. Founded over 25 years ago, OraPharma includes a curated portfolio of treatments for periodontal disease and various regenerative solutions for oral surgery. More information can be found athttps://www.orapharma.com/.
Sobre a Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a diversified global pharmaceutical company whose mission is to improve people's lives with our healthcare products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health through our majority stake in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments by building an innovative company dedicated to advancing global health. For more information visitwww.bauschhealth.comand connect with us atTwittereLinkedIn.
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FAQs
What is ARESTIN microspheres used for? ›
ARESTIN® (minocycline HCl) Microspheres, 1mg is used in combination with scaling and root planing (SRP) procedures to treat patients with adult periodontitis (gum disease). ARESTIN® may be used as part of an overall oral health program that includes good brushing and flossing habits and SRP.
What are the indications for use of ARESTIN? ›INDICATIONS AND USE
ARESTIN is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. ARESTIN may be used as part of a periodontal maintenance program which includes good oral hygiene and scaling and root planing.
ARESTIN (minocycline hydrochloride) microspheres, 1 mg is a subgingival sustained-release product containing the antibiotic minocycline hydrochloride incorporated into a bioresorbable polymer, Poly (glycolide-co-dl-lactide) or PGLA, for professional subgingival administration into periodontal pockets.
What is the mechanism of action of ARESTIN? ›Mechanism of Action
Arestin uses patented microsphere technology to deliver minocycline, a tetracycline antibiotic, beneath the gum, directly into the infected periodontal pocket.
How effective is ARESTIN for smokers with gum disease? In a clinical study, smokers treated with ARESTIN + scaling and root planing (SRP) showed a 29% reduction in pocket depth vs SRP alone.
How much does ARESTIN cost per tooth? ›The cost of Arestin varies from office to office and depends on the number of teeth and pockets involved. Each pocket greater than 5mm will require one dose and is considered one site. Each tooth can potentially have six sites that might require Arrestin. Most dental offices charge between $45 and $85 per site.
Is ARESTIN dental necessary? ›If your gums present with an infection or gum disease, your hygienist may recommend Arestin. Arestin is a prescription local-antibiotic treatment for chronic periodontitis, an infection of the gums. If this condition is not treated, it can lead to bone loss and eventually even tooth loss.
Can you brush your teeth after ARESTIN treatment? ›Wait 12 hours before brushing your teeth in areas that have been treated with ARESTIN®. Wait to floss. Wait 10 days before flossing or using toothpicks or other devices that clean between your teeth in areas that have been treated with ARESTIN®.
Does ARESTIN have side effects? ›The most common side effects of Arestin include: headache, gum discomfort, pain, or soreness, and. toothache.
Why did my dermatologist prescribe minocycline? ›Minocycline is a medication used to treat inflammatory acne. The medication is typically prescribed to people aged 12 years and older who have moderate to severe acne.
Can minocycline cause hair loss? ›
Common minocycline side effects may include: numbness, tingling, burning pain; hair loss; discoloration of you skin or nails.
What are the side effects of minocycline HCL? ›Nausea, vomiting, diarrhea, lightheadedness, dizziness, or a feeling of spinning may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Does ARESTIN help bone loss? ›Perform a comprehensive periodontal evaluation.
Explain that you are looking for signs of periodontal disease, such as increasing pocket depth, radiographic bone loss, and bleeding on probing (BOP), as well as measuring for pockets ≥5 mm. NOTE: ARESTIN is not indicated to prevent bone loss or BOP.
After this medication is placed in your tooth pocket(s), do not touch any treated areas for 7 days. Avoid using treated teeth to chew, and do not eat hard, crunchy, or chewy foods for 7 days.
Is ARESTIN FDA approved? ›Approval Date: 2/16/01.
What foods should you avoid with ARESTIN? ›Don't chew gum or eat sticky or crunchy foods immediately following Arestin placement. After the Arestin® therapy bacteria level in your mouth must be kept at minimum.
Is ARESTIN necessary for deep cleaning? ›A dentist or dental hygienist can administer Arestin after scaling and root planing (deep cleaning), a procedure used to treat periodontal disease. When used together with deep cleaning, Arestin significantly reduces the depth of infected pockets and helps prevent progression of periodontal disease.
How long does it take for gums to heal after scaling and root planing? ›Depending on the severity of your sensitivity, your dentist may also prescribe a stronger toothpaste or rinse. Most patients recover from a dental scaling and root planing procedure within three to five days.
How long does ARESTIN last for? ›ARESTIN® starts working quickly, right at the source of infection, and keeps fighting bacteria long after you leave the dental office. ARESTIN® fights infection and inflammation for 30 days,2 and provides significantly better results than scaling and root planing alone for up to 90 days.
What to do after ARESTIN treatment? ›- Don't Touch. Avoid touching areas of your gums that your hygienist has treated.
- Wait to Brush. Wait 12 hours after your treatment with arestin before brushing your teeth.
- Wait to Floss. ...
- Avoid Eating Hard, Crunchy, or Sticky foods. ...
- Always Follow Up. ...
- Keep Your Scheduled Appointments.
Does ARESTIN stain teeth? ›
ARESTIN® contains minocycline, an antibiotic of the tetracycline class, and therefore should not be used in children and in pregnant or nursing women. The use of drugs of the tetracycline class may cause permanent discoloration of the teeth.
How quickly does ARESTIN work? ›For 21 days after the treatment, Arestin continues to fight and kill bacteria, making it one of the most effective treatments out there. This ensures that the treatment is 100% successful and that no other harmful bacteria can infect your gum tissue. In 4-6 weeks you will see the best results from the treatment.
Can I use mouthwash with ARESTIN? ›Avoid using any strong mouthwashes that contain alcohol. 0 Brush your teeth very lightly in the treated area the first night. Then begin flossing lightly as well the next day, gradually increasing to normal force by the week's end.
How long should you wait to floss after ARESTIN is placed? ›Wait 12 hours after your treatment with Arestin before brushing your teeth. Wait to Floss. Do not floss or use toothpicks or any other devices that clean between your teeth for 10 days. Avoid Eating Hard, Crunchy, or Sticky Foods for 1 week after treatment.
Is ARESTIN covered by insurance? ›Insurance Coverage
Most Dental Insurance Companies do not cover or have only partial coverage for Arestin medication. Recently, however, Arestin has teamed up with CVS to help patients with this problem. For patients with treatments requiring Arestin in multiple sites, an Arestin Request Form can be faxed to CVS.
As a general rule, you should use a Waterpik to help eliminate bacteria in your mouth at least once a day. While this treatment will not rid you of periodontal disease completely, it can help reduce the amount of bacteria in your mouth, making your antibiotics more effective.
How long does it take for gums to heal after periodontal cleaning? ›On average, it takes about 5 – 7 days for your gums to heal after deep cleaning. During this period, it's possible to experience minor gum soreness, swelling, and tooth sensitivity.
What is the strongest antibiotic for gum disease? ›Metronidazole (Flagyl): This antibiotic may be prescribed to those patients suffering from severe periodontitis. Metronidazole works best when used in a combination with amoxicillin or tetracycline.
What medications are bad for your gums? ›Antidepressants – this range of medicines can cause dry mouth and increase the risk of tooth decay. Antihistamines – can cause dry mouth and an increased risk of gum problems. Antihypertensives (taken to reduce blood pressure) – can lead to an increased risk of gum swelling and overgrowth.
Can you drink on ARESTIN? ›No eating or drinking for 30 minutes following treatment • Avoid touching the treated areas. Wait 12 hours after your treatment before brushing teeth. Wait 10 days before using floss, toothpicks, or other devices designed to clean between the treated teeth.
Why can't you eat dairy with minocycline? ›
Some examples include antacids, didanosine solution, quinapril, vitamins/minerals, dairy products (such as milk, yogurt), and calcium-enriched juice. These products bind with minocycline, preventing your body from fully absorbing the drug.
What is the warning for minocycline? ›This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting.
What happens if you take minocycline for too long? ›Minocycline might increase the risk of systemic lupus erythematosus (SLE), autoimmune hepatitis, and polyarteritis nodosa, generally after 1 year of use (SOR B: based on retrospective cohort and case-control studies). Macrolides are associated with cardiac conduction abnormalities and, rarely, hepatotoxicity.
What effect does minocycline have on the brain? ›Several animal studies have been shown that mincocycline is effective in TBI induced neuronal damage (12, 43-46). In models of acute TBI, minocycline reduced microglial activation (44, 45), perihematomal edema (14, 47), Neurological deficits, and brain atrophy (48).
What does minocycline do to your face? ›Minocycline is an antibiotic that works by preventing bacteria from growing and spreading in the body. Minocycline also kills certain bacteria on the skin that can cause acne. Minocycline kills Propionibacterium acnes, the bacteria that causes acne. It also fights inflammation.
What to avoid when taking minocycline? ›For 2 hours before or after you take minocycline: Avoid taking antacids, laxatives, multivitamins, or supplements that contain calcium, magnesium, or iron. These other medicines can make it harder for your body to absorb minocycline. Avoid driving or hazardous activity until you know how this medicine will affect you.
Who should not take minocycline? ›Minocycline may cause permanent discoloration of the teeth and slow down the growth of bones. This medicine should not be given to children younger than 8 years of age unless directed by the child's doctor.
Does minocycline damage gut? ›Minocycline produces significant derangements in the microbiota of the skin and gut, including many probiotic species, highlighting the potential for more targeted antimicrobial treatments for acne.
Is emotions a side effect of minocycline? ›As with other antibiotics, you may experience side effects while on minocycline. Some people taking this medication report increased symptoms of depression — but others report reduced symptoms of depression.
Can you rebuild bone loss in gums? ›There is good news! In most cases, dental bone loss can be stopped. And with expert periodontal care, you can actually regenerate bone and reverse bone loss.
Does bone grow back after periodontal disease? ›
Can bone regenerate after periodontal disease? Bone cannot regenerate on its own after periodontal disease, but bone grafts, membranes, and tissue-stimulating proteins can be used to promote regrowth in areas where bone has been lost.
What vitamins help with dental bone loss? ›Potassium. Like vitamin D, potassium improves your bone mineral density. It also works with magnesium to prevent your blood from becoming too acidic, which can leach calcium from your bones and teeth.
How long does ARESTIN work in the pocket? ›When placed in a periodontal pocket, Arestin® maintains a high-level of antibiotic right at the gum disease site without exposing the rest of the body to antibiotics. This allows treatment using one-hundredth the usual pill-form dose. It directly fights the gum disease infection for 14 days.
Is ARESTIN good for gum disease? ›ARESTIN® (minocycline HCl) Microspheres, 1mg is used in combination with scaling and root planing (SRP) procedures to treat patients with adult periodontitis (gum disease). ARESTIN® may be used as part of an overall oral health program that includes good brushing and flossing habits and SRP.
What can I eat with ARESTIN? ›Most patients who receive the Arestin® dental treatment experience mild to moderate gum sensitivity. This may also be a result of the scaling and root planing. To deal with tooth sensitivity, stick to soft foods like soups, yogurt, and mashed potatoes until the soreness subsides.
How much does ARESTIN cost per site? ›Arestin is charged out at $35-$110 per site (one tooth may have several sites), if a patient has multiple deep pockets in one quadrant the fees can add up quickly.
Why do we use microspheres? ›What Are Microspheres Used For? Precision microspheres and spherical powdes offer benefits in a wide variety of applications - spacers and tracer particles, fillers, medical spheres, fluorescent markers, density marker beads, flow visualization and more.
What are the benefits of microspheres? ›Microspheres can be used in most processing methods for thermoset and thermoplastic polymers such as extrusion and injection molding. They blend easily into compounds, which makes them adaptable to a variety of production processes, including spraying and casting.
What are the disadvantages of microspheres? ›Synthetic polymeric microspheres
and proved to be safe and biocompatible. But the main disadvantage of these kind of microspheres, are tend to migrate away from injection site and lead to potential risk embolism and further organ damage.
Microspheres produce more reproducible drug absorption. Drug discharge in stomach is hindered and that's why local unwanted effects are reduced. In case of microspheres, better therapeutic effect for short half-life of drugs can be achieved. Dose dumping effect can be reduced by microspheres.
What are microspheres a brief review? ›
They are spherical free flowing particles consisting of proteins or synthetic polymers which are biodegradable in nature. There are two types of microspheres; microcapsules and micromatrices, which are described as, Microcapsules are those in which entrapped substance is distinctly surrounded by distinct capsule wall.
Will my gums go back down after deep cleaning? ›While any gum loss experienced due to gum disease will not grow back, the majority of patients can expect their gums to reattach after undergoing a deep cleaning. This is because all of the harmful bacteria has been removed, allowing the gums to once again be healthy.
Do gums heal after deep cleaning? ›On average, it takes about 5 – 7 days for your gums to heal after deep cleaning. During this period, it's possible to experience minor gum soreness, swelling, and tooth sensitivity.
Can you reverse gum disease without deep cleaning? ›Can You Reverse Gum Disease? Yes, you can. At its earliest stages, you can reverse the early signs of gum disease by becoming more diligent with flossing, brushing and using a tongue scraper. Tongue scrapers can be found at drugstores, but even toothbrushes are now designed with a tongue scraper.
What are the two types of microspheres? ›There are two types of microspheres: monolithic-type (matrix-type) and reservoir-type (capsular); the latter of which are called microcapsules [8]. Microspheres are able to incorporate a wide range of different drugs, they are biocompatible and can be prepared from biodegradable particles.
What is the difference between microspheres and nanoparticles? ›Abstract. Nanoparticles are polymeric particles in the nanometer size range whereas microparticles are particles in the micrometre size range.
What is the drug release mechanism of microspheres? ›release from the microsphere occurs by several mechanisms including diffusion, polymer degradation, hy- drolysis or erosion [48] (Fig. ...
What should you not do after ARESTIN? ›- Don't Touch. Avoid touching areas of your gums that your hygienist has treated.
- Wait to Brush. Wait 12 hours after your treatment with arestin before brushing your teeth.
- Wait to Floss. ...
- Avoid Eating Hard, Crunchy, or Sticky foods. ...
- Always Follow Up. ...
- Keep Your Scheduled Appointments.
The most common side effects of Arestin include: headache, gum discomfort, pain, or soreness, and. toothache.