Science News
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A drug marketed to grow bone in osteoporosis patients also works to heal bone wounds in gum disease patients, a University of Michigan study suggests.
"This new approach for the treatment of periodontal disease could allow us to rebuild some of the bone that is lost due to periodontal disease, which until this point has been very difficult to achieve," said Jill Bashutski, clinical assistant professor at the U-M School of Dentistry and first author on the study. "Current treatments to re-grow bone around teeth affected with gum disease have limited success rates."
The findings are significant because gum disease is the leading cause of tooth loss in adults and is associated with a host of other health problems. Periodontal disease results in loss of teeth and can be devastating because it compromises speaking as well as eating, which can in turn contribute to poor nutrition.
The generic name of the drug is teriparatide and it is marketed by Eli Lilly and Co. under the trade name Forteo. It's a type of parathyroid hormone and the only anabolic (meaning it grows bone) osteoporosis drug approved on the market in the United States. Typically, osteoporosis drugs work by preventing bone loss.
The study appears online in the New England Journal of Medicine Oct. 16 and in the print edition Oct. 28. The study was presented Oct. 16 in Toronto at the annual meeting of the American Society for Bone and Mineral Research.
The study took place at the School of Dentistry's Michigan Center for Oral Health Research, where patients with severe chronic gum disease received the traditional treatment for gum disease, which is periodontal surgery on one-quarter of the mouth. Half of the patients took a six-week course of teriparatide by injection into the skin over the abdomen or stomach, plus calcium and vitamin D supplements, while the other half received a placebo.
After one year, researchers saw a 29 percent improvement in bone-level measurements on x-rays in the teriparatide group, versus a 3 percent improvement in the placebo group, a 10-fold increase.
"I think one really interesting aspect of this study is that even a short dosing of this drug had benefits that lasted a year," said Laurie McCauley, U-M professor and chair of periodontics and oral medicine, and principal investigator on the study.
McCauley's research lab has spent nearly two decades studying how parathyroid hormone works. Animal models suggest that it works even better in certain bone wound-healing situations, such as those that involve surgery, than in osteoporosis, which is a diminishing of the bone rather than a wound.
"There was speculation that the bone that forms in a wound like a fracture or inflammatory disease condition might be more responsive to being built back than other bone," said McCauley, who noted that this proved true in the experimental group.
McCauley said the next step is for U-M researchers to test whether the treatment could be delivered locally to target site-specific bone healing. Forteo is not FDA approved for uses other than osteoporosis, but another possible application could be to help grow bone around dental implants.
Wednesday, November 24, 2010
Taking a Closer Look at Plaque
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A team of University of Rochester scientists is using the technique of Raman spectroscopy to study two common dental plaque bacteria, Streptococcus sanguis and mutans. The relative balance of the two may be an indicator of a patient's oral health and risk for tooth decay -- Streptococcus sanguis is associated with "healthy" plaque, while mutans is associated with tooth decay.
Raman spectroscopy offers the potential to analyze samples of the bacterium in a simple, rapid and quantitative manner as compared to microbiology techniques, including the ability to study spatial distributions of bacterial species, living or dead, within samples.
"We're using Raman spectroscopy to study these oral bacterial biofilms, essentially observing how two species scatter light into shifted wavelengths in a unique way. We can then use these characteristic spectra to identify 'unknown' samples of these species," says Brooke Beier, a Ph.D. candidate at the University of Rochester's Institute of Optics. "Studying the spatial distributions of the good vs. bad bacteria under various growth conditions may help scientists determine more effective treatments to prevent tooth decay."
With the ability to identify biofilm samples by species, the researchers can now move on to the study of biofilms grown from a mixture of liquid cultures, where the two species may interact as they grow together.
A team of University of Rochester scientists is using the technique of Raman spectroscopy to study two common dental plaque bacteria, Streptococcus sanguis and mutans. The relative balance of the two may be an indicator of a patient's oral health and risk for tooth decay -- Streptococcus sanguis is associated with "healthy" plaque, while mutans is associated with tooth decay.
Raman spectroscopy offers the potential to analyze samples of the bacterium in a simple, rapid and quantitative manner as compared to microbiology techniques, including the ability to study spatial distributions of bacterial species, living or dead, within samples.
"We're using Raman spectroscopy to study these oral bacterial biofilms, essentially observing how two species scatter light into shifted wavelengths in a unique way. We can then use these characteristic spectra to identify 'unknown' samples of these species," says Brooke Beier, a Ph.D. candidate at the University of Rochester's Institute of Optics. "Studying the spatial distributions of the good vs. bad bacteria under various growth conditions may help scientists determine more effective treatments to prevent tooth decay."
With the ability to identify biofilm samples by species, the researchers can now move on to the study of biofilms grown from a mixture of liquid cultures, where the two species may interact as they grow together.
Substantial Consumption of Fluoride Increases Chance of Mild Fluorosis
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Young children who consume substantial amounts of fluoride through infant formula and other beverages mixed with fluoridated water or by swallowing fluoride toothpaste have an increased chance of developing mild enamel fluorosis, according to research published in the October issue of The Journal of the American Dental Association and supported by the National Institute of Dental and Craniofacial Research. However, experts say, children can continue using fluoridated water and fluoride toothpaste because fluoride has been proven to prevent tooth decay, and mild fluorosis does not negatively affect dental health or quality of life.
"Nearly all of the fluorosis in our study participants was mild. A recent review of the effects of mild dental fluorosis on oral health-related quality of life concluded that the effect of mild fluorosis was not adverse and could even be favorable," according to the study. "This suggests that concerns about mild dental fluorosis may be exaggerated. Therefore, no general recommendations to avoid use of fluoridated water in reconstituting infant formula are warranted. "
According to the American Dental Association, mild enamel fluorosis appears as barely noticeable faint white lines or streaks on tooth enamel that may occur when children ingest excess fluoride while their teeth are developing.
Researchers concluded that substantial fluoride consumption from beverages with fluoridated water, including infant formula, by children between the ages of 3 to 9 months, elevates a child's prospect of developing mild enamel fluorosis. Substantial fluoride consumption from beverages with fluoridated water and from fluoride toothpaste by children between the ages of 16 to 36 months also elevates a child's probability of developing mild enamel fluorosis.
The American Academy of Pediatrics recommends breastfeeding for infants. If parents are concerned about reducing the chances of their infants developing mild fluorosis through consuming substantial amounts of infant formula mixed with fluoridated water, the researchers suggest that they consult with their family dentist or physician. The researchers also encourage parents to follow recommendations to use small (smear or pea-sized) amounts of fluoridated toothpaste and ensure proper supervision of the child's tooth brushing.
Researchers recruited mothers of newborn infants from eight Iowa hospital postpartum wards between 1992 and 1995 for their children's participation in what would become known as the Iowa Fluoride Study, an investigation of dietary and non-dietary fluoride exposures, dental fluorosis and dental cavities. Researchers sent questionnaires to the parents at regular intervals and 630 children underwent visual dental examinations using standardized techniques and portable equipment. The leader of the research team was Steven M. Levy, D.D.S., M.P.H., the Wright-Bush-Shreves Endowed Professor of Research in the Department of Preventive and Community Dentistry at the University of Iowa's College of Dentistry and Professor of Epidemiology at the College of Public Health.
Young children who consume substantial amounts of fluoride through infant formula and other beverages mixed with fluoridated water or by swallowing fluoride toothpaste have an increased chance of developing mild enamel fluorosis, according to research published in the October issue of The Journal of the American Dental Association and supported by the National Institute of Dental and Craniofacial Research. However, experts say, children can continue using fluoridated water and fluoride toothpaste because fluoride has been proven to prevent tooth decay, and mild fluorosis does not negatively affect dental health or quality of life.
"Nearly all of the fluorosis in our study participants was mild. A recent review of the effects of mild dental fluorosis on oral health-related quality of life concluded that the effect of mild fluorosis was not adverse and could even be favorable," according to the study. "This suggests that concerns about mild dental fluorosis may be exaggerated. Therefore, no general recommendations to avoid use of fluoridated water in reconstituting infant formula are warranted. "
According to the American Dental Association, mild enamel fluorosis appears as barely noticeable faint white lines or streaks on tooth enamel that may occur when children ingest excess fluoride while their teeth are developing.
Researchers concluded that substantial fluoride consumption from beverages with fluoridated water, including infant formula, by children between the ages of 3 to 9 months, elevates a child's prospect of developing mild enamel fluorosis. Substantial fluoride consumption from beverages with fluoridated water and from fluoride toothpaste by children between the ages of 16 to 36 months also elevates a child's probability of developing mild enamel fluorosis.
The American Academy of Pediatrics recommends breastfeeding for infants. If parents are concerned about reducing the chances of their infants developing mild fluorosis through consuming substantial amounts of infant formula mixed with fluoridated water, the researchers suggest that they consult with their family dentist or physician. The researchers also encourage parents to follow recommendations to use small (smear or pea-sized) amounts of fluoridated toothpaste and ensure proper supervision of the child's tooth brushing.
Researchers recruited mothers of newborn infants from eight Iowa hospital postpartum wards between 1992 and 1995 for their children's participation in what would become known as the Iowa Fluoride Study, an investigation of dietary and non-dietary fluoride exposures, dental fluorosis and dental cavities. Researchers sent questionnaires to the parents at regular intervals and 630 children underwent visual dental examinations using standardized techniques and portable equipment. The leader of the research team was Steven M. Levy, D.D.S., M.P.H., the Wright-Bush-Shreves Endowed Professor of Research in the Department of Preventive and Community Dentistry at the University of Iowa's College of Dentistry and Professor of Epidemiology at the College of Public Health.
Tuesday, October 5, 2010
Women who get dental care have lower risk of heart disease, says study
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A new study led by a University of California, Berkeley, researcher could give women a little extra motivation to visit their dentist more regularly. The study suggests that women who get dental care reduce their risk of heart attacks, stroke and other cardiovascular problems by at least one-third.
The analysis, which used data from nearly 7,000 people ages 44-88 enrolled in the Health and Retirement Study, did not find a similar benefit for men.
Published online Sept. 29 in the journal Health Economics, the study compared people who went to the dentist during the previous two years with those who did not.
"Many studies have found associations between dental care and cardiovascular disease, but our study is the first to show that general dental care leads to fewer heart attacks, strokes, and other adverse cardiovascular outcomes in a causal way," said study lead author Timothy Brown, assistant adjunct professor of health policy and management at UC Berkeley's School of Public Health.
In the world of health and medical studies, causality is typically determined through randomized controlled trials in which two or more groups of people are essentially equal, except for the receipt of a treatment or intervention, such as a new drug, a periodontal procedure or a health education class. The group that did not receive the treatment – the control group – is compared with the group that did. Differences in outcomes between the groups are attributed to the treatment.
But randomized controlled trials are not always possible, so researchers sometimes turn to a statistical approach called the method of instrumental variables to rule out other potential factors that could account for different outcomes between groups. The use of instrumental variables is common among economists to evaluate the effects of economic policies, but it is less well-known in the clinical setting.
"While relatively short randomized controlled trials of specific types of dental treatment are possible, we can't run long-term randomized controlled trials of whether general dental care reduces cardiovascular disease events like heart attacks and strokes," said Brown, a health economist. "Individuals randomized to the treatment group would enjoy general dental care and those randomized to the control group would get no dental care at all. Many, if not most, people in the control group would simply get dental care on their own, destroying the experimental design, and making the results of the experiment worthless. The method of instrumental variables allows us to avoid this problem."
The method helped researchers rule out self-selection bias, or the possibility that people who seek out dental care are different – perhaps healthier in general – than those who don't.
Data from the Health and Retirement Study had been collected every two years from 1996 to 2004. This longitudinal study followed the same individuals over time, and each biennial survey included questions on whether subjects had visited the dentist and whether they had experienced a heart attack, stroke, angina or congestive heart failure during the prior two years. Deaths from heart attacks or strokes were also included in the analysis. The study took into account other risk factors, such as alcohol and tobacco use, high blood pressure and body mass index.
The fact that men and women did not benefit equally from dental care did not completely surprise the researchers. "To my knowledge, previous studies in this area have found that the relationship between poor oral health and cardiovascular disease markers varies by gender, but none have examined differences between men and women with regard to actual cardiovascular disease events," said Brown, who is also associate director of research at UC Berkeley's Nicholas C. Petris Center on Health Care Markets & Consumer Welfare.
"We think the findings reflect differences in how men and women develop cardiovascular disease," said study co-author Dr. Stephen Brown, a first-year obstetrician/gynecologist resident at the West Virginia University Charleston Division School of Medicine. "Other studies suggest that estrogen has a protective effect against heart disease because it helps prevent the development of atherosclerosis. It's not until women hit menopause around age 50 to 55 that they start catching up with men."
The study authors suggest that for dental care to have a protective effect, it should occur early in the development of cardiovascular disease.
The researchers did not have data on the type of procedures used during the dental visit, but they pointed to other studies that indicated three-fourths of older adult dental visits involved preventive services, such as cleaning, fluoride and sealant treatments.
Oral health experts recommend twice-yearly visits to the dentist, as well as brushing and flossing at least twice a day. Those wearing dentures should make sure they stay clean to prevent the growth and buildup of plaque and bacteria.
A new study led by a University of California, Berkeley, researcher could give women a little extra motivation to visit their dentist more regularly. The study suggests that women who get dental care reduce their risk of heart attacks, stroke and other cardiovascular problems by at least one-third.
The analysis, which used data from nearly 7,000 people ages 44-88 enrolled in the Health and Retirement Study, did not find a similar benefit for men.
Published online Sept. 29 in the journal Health Economics, the study compared people who went to the dentist during the previous two years with those who did not.
"Many studies have found associations between dental care and cardiovascular disease, but our study is the first to show that general dental care leads to fewer heart attacks, strokes, and other adverse cardiovascular outcomes in a causal way," said study lead author Timothy Brown, assistant adjunct professor of health policy and management at UC Berkeley's School of Public Health.
In the world of health and medical studies, causality is typically determined through randomized controlled trials in which two or more groups of people are essentially equal, except for the receipt of a treatment or intervention, such as a new drug, a periodontal procedure or a health education class. The group that did not receive the treatment – the control group – is compared with the group that did. Differences in outcomes between the groups are attributed to the treatment.
But randomized controlled trials are not always possible, so researchers sometimes turn to a statistical approach called the method of instrumental variables to rule out other potential factors that could account for different outcomes between groups. The use of instrumental variables is common among economists to evaluate the effects of economic policies, but it is less well-known in the clinical setting.
"While relatively short randomized controlled trials of specific types of dental treatment are possible, we can't run long-term randomized controlled trials of whether general dental care reduces cardiovascular disease events like heart attacks and strokes," said Brown, a health economist. "Individuals randomized to the treatment group would enjoy general dental care and those randomized to the control group would get no dental care at all. Many, if not most, people in the control group would simply get dental care on their own, destroying the experimental design, and making the results of the experiment worthless. The method of instrumental variables allows us to avoid this problem."
The method helped researchers rule out self-selection bias, or the possibility that people who seek out dental care are different – perhaps healthier in general – than those who don't.
Data from the Health and Retirement Study had been collected every two years from 1996 to 2004. This longitudinal study followed the same individuals over time, and each biennial survey included questions on whether subjects had visited the dentist and whether they had experienced a heart attack, stroke, angina or congestive heart failure during the prior two years. Deaths from heart attacks or strokes were also included in the analysis. The study took into account other risk factors, such as alcohol and tobacco use, high blood pressure and body mass index.
The fact that men and women did not benefit equally from dental care did not completely surprise the researchers. "To my knowledge, previous studies in this area have found that the relationship between poor oral health and cardiovascular disease markers varies by gender, but none have examined differences between men and women with regard to actual cardiovascular disease events," said Brown, who is also associate director of research at UC Berkeley's Nicholas C. Petris Center on Health Care Markets & Consumer Welfare.
"We think the findings reflect differences in how men and women develop cardiovascular disease," said study co-author Dr. Stephen Brown, a first-year obstetrician/gynecologist resident at the West Virginia University Charleston Division School of Medicine. "Other studies suggest that estrogen has a protective effect against heart disease because it helps prevent the development of atherosclerosis. It's not until women hit menopause around age 50 to 55 that they start catching up with men."
The study authors suggest that for dental care to have a protective effect, it should occur early in the development of cardiovascular disease.
The researchers did not have data on the type of procedures used during the dental visit, but they pointed to other studies that indicated three-fourths of older adult dental visits involved preventive services, such as cleaning, fluoride and sealant treatments.
Oral health experts recommend twice-yearly visits to the dentist, as well as brushing and flossing at least twice a day. Those wearing dentures should make sure they stay clean to prevent the growth and buildup of plaque and bacteria.
New approach for treating dry mouth
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A newly published study in the October 2010 issue of The Journal of the American Dental Association (JADA), conducted at New York University's College of Dentistry, confirms the safety and efficacy of a new novel method for controlling xerostomia, or dry mouth. The double masked, randomized controlled crossover study concludes that use of a unique mucoadhesive patch, affixed to the hard palate inside the mouth, provides statistically significant and sustainable improvements in salivary flow rates and subjective moistness for dry mouth sufferers. An estimated 30 million Americans deal with this uncomfortable oral health condition.
This latest study comes on the heels of another published study (March 2010 issue of Quintessence International) that showed these patches provided better performance for dry mouth sufferers than a leading over-the-counter dry mouth spray.
Chronic dry mouth is an under-diagnosed condition that can have a detrimental effect on oral health by contributing to tooth decay, gum disease and chronic bad breath. It can be a symptom of other medical conditions, such as diabetes or Sjogren's Syndrome, and is also the result of radiation treatment for head and neck cancer, but it is most often a side effect of many prescription and over-the-counter medications taken daily by millions of Americans (34% of people on three or more medications will likely have this condition).
The mucoadhesive patches tested in the study are available to consumers under the brand name OraMoist™ and sold over-the-counter at retailers, such as Rite-Aid and Walgreen's, nationwide. Approximately one centimeter in diameter, the patches can adhere to any oral mucosal surface, such as the roof of the mouth or inside the cheek, and the study confirmed can yield a "statistically significant improvement in baseline subjective and objective measures of dry mouth for up to 60 minutes – and possibly longer – after application."
The JADA study also found that after two weeks of daily use, participants experienced a statistically significant improvement in baseline subjective and objective measures of salivary flow. This, according to the researchers, suggests a sustained effect.
"One of the results was that after two weeks of use of the patch, the amount of saliva in the mouth had increased even during times when there was no patch in the mouth," says the study's lead author A. Ross Kerr, DDS, MSD, clinical associate professor at New York University College of Dentistry. "In other words, the patch would seem to have a cumulative beneficial effect."
According to Dr. Kerr, OraMoist provides an appealing and convenient alternative to other dry mouth treatments, which are usually in spray, rinse or gel form and require the user to replenish when necessary – which can be up to every 20 minutes. Overnight, the sustained effect is of particular benefit.
"The OraMoist patches offer pleasant tasting and longer-lasting option for the management of dry mouth, which becomes a quality of life issue for sufferers," says Dr. Kerr. In this and the Quintessence International study, approximately 70% of participants stated they would use the patch again.
OraMoist Dry Mouth Patch is a time-released mucoadhesive patch that moistens and lubricates the mouth, while simultaneously stimulating saliva production, day or night. . The patch can last for up to four hours and is the only such sustained release dry mouth product available over-the-counter.
The placebo mucoadhesive patches used in this study were made using the same unique, patented technology as the OraMoist patches. Unlike the unloaded placebo patch, the loaded patch, OraMoist, is enhanced by natural ingredients including natural lipids, oral enzymes, citrus oil, sea salt, calcium carbonate, natural lemon and xylitol. According to the company, the researchers behind the patch believe that these additional ingredients also play a role in inhibiting bacterial growth and promoting oral health. Based on the results of this study, further investigation of these benefits is warranted.
The patented mucoadhesive patch technology was developed by Professor Abraham J. Domb, PhD, Institute of Drug Research, School of Pharmacy, Faculty of Medicine at the Hebrew University. Dr. Domb is a leading worldwide authority on mucoadhesive technology/bio-degradable polymer research. The same patch technology has also been successfully adapted for the treatment of aphtous ulcers, or canker sores.
JADA Study Findings Summary: Use of Mucoadhesive Patch for Relief of Chronic Dry Mouth
Significant increase in objectively-measured salivary flow rates in those using OraMoist
A "sustained effect" for OraMoist – the patients using it benefited more on their 4th and 5th weeks than on their 3rd; increased baseline of improvement
96% of patients said OraMoist was easy to use; 82% said OraMoist did not interfere with eating or talking; 74% said the flavor was pleasant.
OraMoist is safe. There were no adverse events reported in the study.
A newly published study in the October 2010 issue of The Journal of the American Dental Association (JADA), conducted at New York University's College of Dentistry, confirms the safety and efficacy of a new novel method for controlling xerostomia, or dry mouth. The double masked, randomized controlled crossover study concludes that use of a unique mucoadhesive patch, affixed to the hard palate inside the mouth, provides statistically significant and sustainable improvements in salivary flow rates and subjective moistness for dry mouth sufferers. An estimated 30 million Americans deal with this uncomfortable oral health condition.
This latest study comes on the heels of another published study (March 2010 issue of Quintessence International) that showed these patches provided better performance for dry mouth sufferers than a leading over-the-counter dry mouth spray.
Chronic dry mouth is an under-diagnosed condition that can have a detrimental effect on oral health by contributing to tooth decay, gum disease and chronic bad breath. It can be a symptom of other medical conditions, such as diabetes or Sjogren's Syndrome, and is also the result of radiation treatment for head and neck cancer, but it is most often a side effect of many prescription and over-the-counter medications taken daily by millions of Americans (34% of people on three or more medications will likely have this condition).
The mucoadhesive patches tested in the study are available to consumers under the brand name OraMoist™ and sold over-the-counter at retailers, such as Rite-Aid and Walgreen's, nationwide. Approximately one centimeter in diameter, the patches can adhere to any oral mucosal surface, such as the roof of the mouth or inside the cheek, and the study confirmed can yield a "statistically significant improvement in baseline subjective and objective measures of dry mouth for up to 60 minutes – and possibly longer – after application."
The JADA study also found that after two weeks of daily use, participants experienced a statistically significant improvement in baseline subjective and objective measures of salivary flow. This, according to the researchers, suggests a sustained effect.
"One of the results was that after two weeks of use of the patch, the amount of saliva in the mouth had increased even during times when there was no patch in the mouth," says the study's lead author A. Ross Kerr, DDS, MSD, clinical associate professor at New York University College of Dentistry. "In other words, the patch would seem to have a cumulative beneficial effect."
According to Dr. Kerr, OraMoist provides an appealing and convenient alternative to other dry mouth treatments, which are usually in spray, rinse or gel form and require the user to replenish when necessary – which can be up to every 20 minutes. Overnight, the sustained effect is of particular benefit.
"The OraMoist patches offer pleasant tasting and longer-lasting option for the management of dry mouth, which becomes a quality of life issue for sufferers," says Dr. Kerr. In this and the Quintessence International study, approximately 70% of participants stated they would use the patch again.
OraMoist Dry Mouth Patch is a time-released mucoadhesive patch that moistens and lubricates the mouth, while simultaneously stimulating saliva production, day or night. . The patch can last for up to four hours and is the only such sustained release dry mouth product available over-the-counter.
The placebo mucoadhesive patches used in this study were made using the same unique, patented technology as the OraMoist patches. Unlike the unloaded placebo patch, the loaded patch, OraMoist, is enhanced by natural ingredients including natural lipids, oral enzymes, citrus oil, sea salt, calcium carbonate, natural lemon and xylitol. According to the company, the researchers behind the patch believe that these additional ingredients also play a role in inhibiting bacterial growth and promoting oral health. Based on the results of this study, further investigation of these benefits is warranted.
The patented mucoadhesive patch technology was developed by Professor Abraham J. Domb, PhD, Institute of Drug Research, School of Pharmacy, Faculty of Medicine at the Hebrew University. Dr. Domb is a leading worldwide authority on mucoadhesive technology/bio-degradable polymer research. The same patch technology has also been successfully adapted for the treatment of aphtous ulcers, or canker sores.
JADA Study Findings Summary: Use of Mucoadhesive Patch for Relief of Chronic Dry Mouth
Significant increase in objectively-measured salivary flow rates in those using OraMoist
A "sustained effect" for OraMoist – the patients using it benefited more on their 4th and 5th weeks than on their 3rd; increased baseline of improvement
96% of patients said OraMoist was easy to use; 82% said OraMoist did not interfere with eating or talking; 74% said the flavor was pleasant.
OraMoist is safe. There were no adverse events reported in the study.
Friday, October 1, 2010
FDA warns three companies to stop making unproven claims on mouth rinses
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The FDA has issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.
The FDA has issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. These claims suggest the products are effective in preventing gum disease when no such benefit has been demonstrated.
Warning letters were sent to, Johnson & Johnson (Listerine Total Care Anticavity Mouthwash), CVS Corporation (CVS Complete Care Anticavity Mouthwash), and Walgreen Company (Walgreen Mouth Rinse Full Action).
These mouth rinse products contain the active ingredient sodium fluoride. The FDA has determined that sodium fluoride is effective in preventing cavities but has not found this ingredient to be effective in removing plaque or preventing gum disease.
“It is important for the FDA to take appropriate enforcement action when companies make false or unproven product claims to ensure that consumers are not misinformed or misled,” said Deborah Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research.
Under federal law, a company cannot claim its product is effective in treating a disease unless those claims have been reviewed and approved by the FDA in a new drug application or the active ingredient has been generally recognized as safe and effective for these claims in an over-the-counter (OTC) drug monograph.
The FDA actions are part of the agency’s effort to curtail an increasing number of Federal Food Drug and Cosmetic Act (FFDCA) violations among the makers/marketers of mouthwashes concerning unproven claims of therapeutic benefits.
To date, the FDA is unaware of any injuries or adverse health effects related to the use of these mouth rinse products. Consumers who have these products may continue to use the products for cavity prevention without risk of injury but should be aware that the FDA has no data to show that these products can prevent gum disease.
Companies that received FDA warning letters are required to take appropriate action to correct these violations within 15 days. Failure to do so may result in seizure of the product, or other civil or criminal penalties.
For more information:
EPA Will Propose Rule to Protect Waterways by Reducing Mercury from Dental Offices
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The U.S. Environmental Protection Agency (EPA) today announced it intends to propose a rule to reduce mercury waste from dental offices. Dental amalgams, or fillings containing mercury, account for 3.7 tons of mercury discharged from dental offices each year. The mercury waste results when old mercury fillings are replaced with new ones. The mercury in dental fillings is flushed into chair-side drains and enters the wastewater systems, making its way into the environment through discharges to rivers and lakes, incineration or land application of sewage sludge. Mercury released through amalgam discharges can be easily managed and prevented.
EPA expects to propose a rule next year and finalize it in 2012. Dental offices will be able to use existing technology to meet the proposed requirements. Amalgam separators can separate out 95 percent of the mercury normally discharged to the local waste treatment plant. The separator captures the mercury, which is then recycled and reused.
Until the rule is final, EPA encourages dental offices to voluntarily install amalgam separators. Twelve states and several municipalities already require the installation of amalgam separators in dental offices.
Approximately 50 percent of mercury entering local waste treatment plants comes from dental amalgam waste. Once deposited, certain microorganisms can change elemental mercury into methylmercury, a highly toxic form that builds up in fish, shellfish and animals that eat fish.
Fish and shellfish are the main sources of methylmercury exposure to humans. Methylmercury can damage children’s developing brains and nervous systems even before they are born.
More information on mercury from dental offices
More information on mercury and the environment
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The U.S. Environmental Protection Agency (EPA) today announced it intends to propose a rule to reduce mercury waste from dental offices. Dental amalgams, or fillings containing mercury, account for 3.7 tons of mercury discharged from dental offices each year. The mercury waste results when old mercury fillings are replaced with new ones. The mercury in dental fillings is flushed into chair-side drains and enters the wastewater systems, making its way into the environment through discharges to rivers and lakes, incineration or land application of sewage sludge. Mercury released through amalgam discharges can be easily managed and prevented.
EPA expects to propose a rule next year and finalize it in 2012. Dental offices will be able to use existing technology to meet the proposed requirements. Amalgam separators can separate out 95 percent of the mercury normally discharged to the local waste treatment plant. The separator captures the mercury, which is then recycled and reused.
Until the rule is final, EPA encourages dental offices to voluntarily install amalgam separators. Twelve states and several municipalities already require the installation of amalgam separators in dental offices.
Approximately 50 percent of mercury entering local waste treatment plants comes from dental amalgam waste. Once deposited, certain microorganisms can change elemental mercury into methylmercury, a highly toxic form that builds up in fish, shellfish and animals that eat fish.
Fish and shellfish are the main sources of methylmercury exposure to humans. Methylmercury can damage children’s developing brains and nervous systems even before they are born.
More information on mercury from dental offices
More information on mercury and the environment
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