Cathy Hester Seckman, RDH, worked in dentistry 32
years, including 12 years as a pediatric hygienist.
Officially retired from clinical hygiene, she still fills in
occasionally at the same pediatric practice. She is a
frequent contributor to dental magazines, works
part-time as an indexer, and is the author of two novels,
more than a dozen short stories, and an Arcadia
Publishing history of her hometown.
1. United States Department of Health and Human
Services Federal Panel on Community Water Fluoridation. U.S. Public Health Service Recommendation
for fluoride concentration in drinking water for the
prevention of dental caries. http://www.publicheal-
Guidelines.pdf. Published July–August 2015.
2. Hicks J. Pipe dreams: America’s fluoride controversy. Chemical Heritage Magazine website. http://
versy.aspx?page= 1. Published 2011.
3. Kliff S. A brief history of America’s fluoride wars.
Washington Post website. https://www.washington-
of-americas-fluoride-wars/. Published May 21, 2013.
4. Erin Brokovitch [sic] and Dr. Oz [video clip]. You-Tube. Originally aired on: “Breaking news: The Zika
virus: A public health emergency in the making?”;
The Dr. Oz Show; February 1, 2016. https://www.
youtube.com/watch?v=HBHwQ-jf TAY. Published
February 10, 2016.
trast, tells us that fluoridation has indeed been
rejected by some U.S. communities, but the number of communities accepting fluoridation has
increased steadily over the past decade.
9 According to 2014 statistics from the Pew Charitable
Trusts, 74.6% of US citizens in each state, on
average, have access to fluoridated water.
10 In my
state, Ohio, the percentage of residents who receive fluoridated water is 92.2%.
FAN also states that fluoride has been linked
with osteosarcoma, citing a 2006 study by Bassin
et al., from the Harvard School of Dental Medicine.
11 Here’s a concluding quote from the actual
study: “Our exploratory analysis found an association between fluoride exposure in drinking
water during childhood and the incidence of
osteosarcoma among males but not consistently
among females. Further research is required to
confirm or refute this observation,” (emphasis
The American Cancer Association also addressed the question about whether fluoride
might be linked to cancer. Its website reports that
in 2006, the National Research Council updated
a 1993 review of the subject. The conclusion was
that “evidence on the potential of fluoride to
initiate or promote cancers, particularly of the
bone, is tentative and mixed.”
Another FAN claim is that fluoride exposure
“may also lead to increased insulin resistance.”
FAN cites a study that was published in the
Chinese Journal of Endemiology in 2000.16 A look at
the research reveals that the population studied
comprised adults between the ages of 40 and 68
who lived in a remote village with water naturally
high in fluoride.
16 No low-fluoride water or water
improvement was available to the villagers.
For a different viewpoint, consider this article
in the Journal of Dental Research, published in
July 2015: “Low-level fluoride exposure increases
insulin sensitivity in experimental diabetes.” For
purposes of the study, diabetes was induced in
rats, and the rats were then given either 0, 10, or
50 mgF/liter. The results suggested that low levels
of fluoride might enhance glucose stability.
It should be pointed out that we’re still waiting
for the final word on community fluoridation.
Research and reviews of research continue, and
the optimal amount of added fluoride may change
again. These are the current facts, though, and
it’s our responsibility as dental health professionals to understand and present a complete picture
of the ongoing fluoridation controversy to our
to turn for
continued on pg. 82
neutral fluoride dentifrice
containing 1.1% (w/w)
sodium fluoride for use as a
dental caries preventive in
adults and pediatric patients.
Active Ingredient: Sodium
fluoride 1.1% (w/ w)
INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe
and extraordinarily effective as a caries preventive when applied frequently
with mouthpiece applicators. 1-4 PreviDent® 5000 BoosterPlus brand of
1.1% sodium fluoride toothpaste in a squeeze bottle is easily applied onto
a toothbrush. This prescription toothpaste should be used once daily in
place of your regular toothpaste unless otherwise instructed by your dental
professional. May be used in areas where drinking water is fluoridated since
topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
CONTRAINDICATIONS: Do not use in pediatric patients under age 6 years
unless recommended by a dentist or physician.
WARNINGS: Prolonged daily ingestion may result in various degrees
of dental fluorosis in pediatric patients under age 6 years, especially if
the water fluoridation exceeds 0.6 ppm, since younger pediatric patients
frequently cannot perform the brushing process without significant
swallowing. Use in pediatric patients under age 6 years requires special
supervision to prevent repeated swallowing of toothpaste which could
cause dental fluorosis. Pediatric patients under age 12 should be supervised
in the use of this product. Read directions carefully before using. Keep out of
reach of infants and children.
General: Not for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study
conducted in rodents, no carcinogenesis was found in male and female
mice and female rats treated with fluoride at dose levels ranging from 4. 1
to 9. 1 mg/kg of body weight. Equivocal evidence of carcinogenesis was
reported in male rats treated with 2. 5 and 4. 1 mg/kg of body weight. In
a second study, no carcinogenesis was observed in rats, males or females,
treated with fluoride up to 11. 3 mg/kg of body weight. Epidemiological
data provide no credible evidence for an association between fluoride, either
naturally occurring or added to drinking water, and risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems. It has been
shown that fluoride ion has potential to induce chromosome aberrations
in cultured human and rodent cells at doses much higher than those to
which humans are exposed. In vivo data are conflicting. Some studies report
chromosome damage in rodents, while other studies using similar protocols
report negative results.
Potential adverse reproductive effects of fluoride exposure in humans have
not been adequately evaluated. Adverse effects on reproduction were
reported for rats, mice, fox, and cattle exposed to 100 ppm or greater
concentrations of fluoride in their diet or drinking water. Other studies
conducted in rats demonstrated that lower concentrations of fluoride ( 5
mg/kg of body weight) did not result in impaired fertility and reproductive
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been
shown that fluoride crosses the placenta of rats, but only 0.01% of the
amount administered is incorporated in fetal tissue. Animal studies (rats,
mice, rabbits) have shown that fluoride is not a teratogen. Maternal
exposure to 12. 2 mg fluoride/kg of body weight (rats) or 13. 1 mg/kg of
body weight (rabbits) did not affect the litter size or fetal weight and did
not increase the frequency of skeletal or visceral malformations. There are
no adequate and well-controlled studies in pregnant women. However,
epidemiological studies conducted in areas with high levels of naturally
fluoridated water showed no increase in birth defects. Heavy exposure to
fluoride during in utero development may result in skeletal fluorosis which
becomes evident in childhood.
Nursing Mothers: It is not known if fluoride is excreted in human milk.
However, many drugs are excreted in milk, and caution should be exercised
when products containing fluoride are administered to a nursing woman.
Reduced milk production was reported in farm-raised fox when the animals
were fed a diet containing a high concentration of fluoride (98-137 mg/kg
of body weight). No adverse effects on parturition, lactation, or offspring
were seen in rats administered fluoride up to 5 mg/kg of body weight.
Pediatric Use: The use of PreviDent® 5000 BoosterPlus in pediatric age
groups 6 to 16 years as a caries preventive is supported by pioneering
clinical studies with 1.1% sodium fluoride gels in mouth trays in
students age 11 to 14 years conducted by Englander et al. 2-4 Safety and
effectiveness in pediatric patients belo w the age of 6 years have not been
established. Please refer to the CONTRAINDICATIONS and WARNINGS
Geriatric Use: Of the total number of subjects in clinical studies of 1.1%
(w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were
75 and over. No overall differences in safety or effectiveness were observed
between these subjects and younger subjects, and other reported clinical
experience has not identified differences in responses bet ween the elderly
and younger patients, but greater sensitivity of some older individuals
cannot be ruled out. This drug is known to be substantially excreted by the
kidney, and the risk of toxic reactions to this drug may be greater in patients
with impaired renal function. Because elderly patients are more likely to
have decreased renal function, care should be taken in dose selection, and it
may be useful to monitor renal function.
ADVERSE REAC TIONS: Allergic reactions and other idiosyncrasies have
been rarely reported.
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may
result in acute burning in the mouth and sore tongue. Nausea, vomiting,
and diarrhea may occur soon after ingestion (within 30 minutes) and
are accompanied by salivation, hematemesis, and epigastric cramping
abdominal pain. These symptoms may persist for 24 hours. If less than 5
mg fluoride/kg body weight (i.e., less than 2. 3 mg fluoride/lb body weight)
has been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal
symptoms and observe for a few hours. If more than 5 mg fluoride/kg
body weight (i.e., more than 2. 3 mg fluoride/lb body weight) has been
ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium
gluconate or calcium lactate solution) and immediately seek medical
assistance. For accidental ingestion of more than 15 mg fluoride/kg of body
weight (i.e., more than 6. 9 mg fluoride/lb body weight), induce vomiting
and admit immediately to a hospital facility.
A treatment dose (a thin ribbon) of PreviDent® 5000 BoosterPlus contains
approximately 2. 5 mg fluoride. A 3. 4 FL OZ (100 mL) bottle contains
approximately 605 mg fluoride.
DOSAGE AND ADMINISTRATION: Follow these instructions unless
otherwise instructed by your dental professional:
1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon
of PreviDent® 5000 BoosterPlus to a toothbrush. Brush teeth thoroughly
once daily for two minutes, preferably at bedtime, in place of your regular
2. After use, adults expectorate. For best results, do not eat, drink, or rinse
for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse
1.1% Sodium Fluoride
PRESCRIPTION STRENGTH TOOTHPASTE