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Uses

Prevention of Dental Caries

Fluoride is used to reduce the incidence of dental caries and to slow or reverse the progression of existing dental lesions. Exposure to small amounts of oral and topical fluoride on a daily basis will reduce the risk for dental caries in all age groups. It was previously hypothesized that fluoride inhibited dental caries by a preeruptive effect (i.e., incorporation into developing dental enamel), but further laboratory and clinical research now indicates that the predominant effect is posteruptive, making consistent maintenance of a small amount of fluoride in saliva and dental plaque important.

Combined use of fluoridated dentifrices and fluoridated water has been found to provide greater protection against dental caries than either source alone. The US Centers for Disease Control and Prevention (CDC) recommends that adults and children at low risk for dental caries drink water with an optimal fluoride concentration and brush their teeth twice daily with a fluoridated dentifrice to prevent and control dental caries; those at higher risk for dental caries may require additional exposure to fluorides (e.g., mouth rinses, dietary supplements, preparations applied by dental personnel). The American Dental Association (ADA) and some clinicians recommend that, in patients without dental caries and with no apparent increased risk for dental caries, adequate water fluoridation or oral fluoride supplementation, combined with daily use of fluoridated dentrifice and semiannual topical applications of fluoride by dental professionals, may be appropriate. Individuals with, or at increased risk for, dental caries may require additional exposure to fluorides. Those with low rates of dental caries, or with a slightly increased risk, may require the addition of sodium fluoride 0.05% mouth rinse or 0.4% stannous fluoride gel. Those with moderate to high rates of dental caries, or with a moderately to greatly increased risk, also may require daily use of a neutral sodium fluoride 1.1% gel or an acidulated phosphate fluoride gel containing sodium fluoride 1.1%.

Patients at increased risk for dental caries include those with low socioeconomic status or low levels of parental education, those who do not seek regular dental care, and those without dental insurance or access to dental services. Additional risk factors include a high incidence of dental caries in older siblings or caregivers, root surfaces exposed by gingival recession, high levels of infection with cariogenic bacteria, impaired ability to maintain oral hygiene, malformed enamel or dentin, reduced salivary flow (because of medications, radiation, or disease), low salivary buffering capacity (i.e., decreased ability of saliva to neutralize acids), and wearing of space maintainers, orthodontic appliances, or dental prostheses. The risk of dental caries can increase if these risk factors are combined with dietary practices conducive to dental caries (i.e., frequent consumption of refined carbohydrates). The dental or health-care provider must periodically evaluate the individual's risk for dental caries, current fluoride sources, and potential for enamel fluorosis before recommending supplemental fluoride therapy.

Community Water Fluoridation

The most effective means of providing optimal levels of fluoride to large segments of the population is fluoridation of public water supplies. The CDC states that there is good evidence to support fluoridation of the public water supply to prevent and control dental caries. The optimal concentration of fluoride ion in drinking water to prevent dental caries is approximately 1 ppm (mg/L); however, optimal concentrations range from 0.7-1.2 ppm (mg/L) depending on the annual mean maximum daily temperature of the area, and concentrations should be at the lower end of the range in warm climates where more water is likely to be ingested. The National Academy of Sciences (NAS) states that the Adequate Intake (AI) of fluoride to prevent dental caries in children older than 6 months of age and in adults is 0.05 mg/kg daily, which coincides with the average dietary intake by US infants and children since 1980 in areas with optimally fluoridated water. Average dietary intakes for adults living in US communities with fluoridated water have ranged from 0.02-0.05 mg/kg daily. (For a definition of Adequate Intake and limitations on its use relative to Recommended Dietary Allowances [RDAs] and other reference values for dietary nutrient intakes, see Uses: Dietary Requirements, in Calcium Salts 40:12 and in the Vitamin D Analogs General Statement 88:16.)

In some communities where fluoridation of the water supply was not possible (e.g., rural areas), fluoridation of the school's water supply (at a concentration of 4.5 times the optimal concentration to compensate for the more limited consumption of fluoridated water outside the school) was promoted to provide a source of fluoride for children in the community. Although studies evaluating the effects of school water fluoridation reported a 40% reduction in dental caries in school children, the trials were not blinded and lacked concurrent controls. Therefore, CDC states that the appropriateness of this practice is limited and alternative fluoride sources should be considered.

Because consumption of commercially available beverages (including bottled water) in the US and Canada is displacing the consumption of tap or well water, the relative importance of fluoridation of local community water on fluoride intake may be affected. Some evidence indicates that more than 50-75% of fluid intake in children and adolescents may be from commercially available beverages. Thus, the fluoride concentration of water used in the preparation of these commercial beverages is an important factor affecting fluoride intake in the US and Canada. Despite this, however, current recommendations for fluoride supplementation in children continue to be based on the fluoride concentrations in local drinking water.(See Prevention of Dental Caries: Oral Fluorides, in Uses.)

Some community water supplies naturally contain fluoride at concentrations exceeding 2 ppm, a concentration associated with an increased risk for development of enamel fluorosis in children 8 years of age or younger. (See Cautions: Effects on Teeth.) In communities where the concentration of fluoride in the water supply exceeds 2 ppm, an alternative source of drinking water should be used for children 8 years of age or younger.

In areas where naturally occurring concentrations of fluoride in drinking water are inadequate and community water fluoridation programs are not available or feasible, daily administration of individualized fluoride supplements is used in children to provide adequate levels of fluoride ion to protect against dental caries. Fluoride supplements can be administered orally or applied topically directly to the teeth. The route of administration depends partly on the age of the child. Oral administration of fluoride is the method of choice, especially for young children. Topical application or oral rinsing solutions may be preferred for children whose permanent teeth have already erupted. Children younger than 14 years of age who are highly susceptible to dental caries may benefit from receiving both oral and topical fluoride supplements.

Oral Fluorides

Sodium fluoride oral solutions and oral tablets are used as dietary supplements for the prevention of dental caries in children in areas where the concentration of fluoride ion in drinking water is less than optimal. Dosage is based on the concentration of fluoride in the drinking water and the child's age. Consideration also should be given to sources of fluoride other than the child's primary drinking water (e.g., other water supplies in the home, childcare settings, school; bottled water or processed beverages; dentifrice or mouth rinse) before selecting the dosage of fluoride to be prescribed.Oral fluoride supplements should not be used in areas where the fluoride content of drinking water exceeds 0.6 ppm (mg/L). The CDC states that there is good evidence to support the use of oral fluoride supplements in children 6-16 years of age who are at increased risk for dental caries and whose primary drinking water has a low fluoride concentration; however, clinical trials conducted in children younger than 6 years of age have been flawed in design and conduct, and there are no clinical studies to confirm the effectiveness of oral fluoride supplements in controlling dental caries in adults and children older than 16 years of age. Beginning in 1979, infant formula manufacturers in the US began to uniformly manufacture ready-to-use and liquid concentrate formulas with defluoridated water so that these preparations contain low fluoride concentrations (less than 0.3 ppm [mg/L]); therefore, fluoride concentrations in infant formulas that require reconstitution depend on the amount of fluoride added locally as fluoridated water prior to use.

The ADA, American Academy of Pediatric Dentistry (AAPD), and American Academy of Pediatrics (AAP) currently state that in areas where oral fluoride supplements are necessary, children should receive fluoride supplements daily from 6 months of age until approximately 16 years of age to provide maximum benefit to both deciduous and permanent teeth. The ADA, AAPD, and AAP currently recommend that children 6 months to younger than 3 years of age receive 0.25 mg of oral fluoride daily in areas where the concentration of fluoride ion in drinking water is less than 0.3 ppm (mg/L); children 3 to younger than 6 years of age should receive 0.5 or 0.25 mg of oral fluoride in areas where the concentration of fluoride ion in drinking water is less than 0.3 or 0.3-0.6 ppm (mg/L), respectively. Children 6-16 years of age should receive 1 or 0.5 mg of oral fluoride in areas where the concentration of fluoride ion in drinking water is less than 0.3 or 0.3-0.6 ppm (mg/L), respectively.

Although fluoride is distributed into milk, concentrations generally are less than 0.05 ppm (mg/L) and infants who are solely breast-fed ingest considerably less fluoride than infants receiving formula diluted with fluoridated drinking water. In the past, the ADA, AAP, and most clinicians have stated that oral fluoride supplements should be considered for infants who are solely breast-fed (i.e., those not receiving water, juice, or solid foods), especially those breast-fed for more than 6 months. However, the ADA and AAP currently do not recommend oral fluoride supplements in infants younger than 6 months of age, since limited evidence (based on caries rates between solely breast-fed infants not receiving fluoride supplements and infants receiving formula diluted with fluoridated water) suggests that fluoride supplementation may not be necessary for solely breastfed infants living in areas with adequately fluoridated water.

Sodium fluoride is commercially available in multivitamin or multivitamin/iron preparations for use as oral fluoride supplements in infants and children. However, the ADA currently states that the fixed proportion of fluoride contained in these combination preparations makes it difficult to appropriately adjust the amount of fluoride needed in areas where drinking water contains substantial but inadequate concentrations of fluoride.

Sodium fluoride has been administered orally to pregnant women to prevent caries in the deciduous teeth of their children; however, the ADA states that well-designed studies demonstrating the safety and efficacy of prenatal fluoride supplementation are lacking and currently does not recommend use of fluoride supplements during pregnancy. The ADA also states that fluoride dietary supplements administered to pregnant women will not affect permanent dentition in their children because the permanent teeth do not begin to develop in utero. In addition, the CDC states that there is good evidence that fluoride supplements administered orally to pregnant women provide no benefit for their children.

Topical Fluorides

Sodium fluoride, acidulated phosphate fluoride (sodium fluoride and phosphoric acid), and stannous fluoride are applied directly to the surfaces of teeth in the form of solutions, foams, creams, or gels for the prevention of dental caries in children and adults. Topical application of fluoride can be used as an alternative to oral administration to provide supplemental fluoride to children who live in areas with inadequate concentrations of fluoride ion in drinking water. Topical application of fluoride also can be used to provide additional anticaries benefits in areas where drinking water contains adequate concentrations of fluoride ion.

The effectiveness of topically applied fluoride varies according to the concentration of fluoride ion in the preparation and the method and frequency of application; efficacy also may depend on the duration of use. The CDC states that there is good evidence to support the use of topical fluorides (rinses, gels) in patients at increased risk for dental caries. The CDC also states that there is good evidence obtained from one or more properly conducted randomized clinical trials to support the use of fluoridated dentrifices in all individuals; in children younger than 2 years of age, other sources of fluoride should be considered when weighing the risks and benefits of using fluoridated dentrifice. Topical application of sodium fluoride solutions (usually a 2% solution) has been reported to result in a 30-40% reduction in the incidence of dental caries in children 6-12 years of age. In more recent studies, semiannual application of fluoride preparations by dental personnel reportedly resulted in an average reduction of 26% in the incidence of dental caries in the permanent teeth of children residing in areas without fluorodated water. The beneficial effects of topical fluorides (e.g., dentifrices, gels, rinses) have not been adequately studied in adults; however, teeth remain susceptible to caries throughout life, and administration of topical fluoride could be effective in preventing dental caries at any age. On the basis of available evidence from clinical studies, the CDC states that in patients at increased risk for dental caries, the recommended frequency for application of topical fluorides by dental personnel is semiannually.

Oral rinsing solutions containing 0.05 or 0.2% sodium fluoride and oral rinsing solutions of acidulated phosphate fluoride containing 0.02% fluoride ion are used to provide additional anticaries benefits in children 6 years of age and older. Oral rinsing solutions containing 0.63% stannous fluoride are diluted and used as 0.1% solutions to provide additional anticaries benefits in children 12 years of age and older. When recommended by a clinician, some of these solutions (e.g., Phos-Flur) can be used as a rinsing solution and then swallowed to provide topical and systemic fluoride in children 3 years of age and older who live in areas where the fluoride content in drinking water is less than optimal. (See Oral Fluorides under Uses: Prevention of Dental Caries.) Daily use of oral rinsing solutions containing 0.05% sodium fluoride or once-weekly use of rinsing solutions containing 0.2% sodium fluoride reportedly results in a 30-40% reduction in the incidence of dental caries in children who live in areas without fluoridated drinking water and also has been shown to provide additional anticaries benefits in children who live in areas with optimally fluoridated drinking water. Preliminary data indicate that there is no substantial difference in effectiveness between daily and weekly use of sodium fluoride oral rinsing solutions.

Acidulated phosphate fluoride gels or solutions containing 0.5-1.23% fluoride ion have been effective when used topically to control dental decay that frequently follows xerostomia-producing radiation therapy of tumors of the head and neck; these preparations are often used in conjunction with a saliva substitute (e.g., Xero-Lube) in patients with this condition. Gels containing 0.4% stannous fluoride also have been used to prevent decalcification in orthodontic patients and to protect against postirradiation caries.

Certain dentifrices containing sodium fluoride (e.g., Crest Cavity Protection Gel, Colgate Total) or sodium monofluorophosphate (e.g., Aquafresh Extra Fresh Toothpaste, Colgate Cavity Protection Gel, Colgate Cavity Protection Toothpaste) have been shown to be effective in reducing the incidence of dental caries in children when used in association with a program of good oral hygiene.

Intake from fluoridated dental products such as dentifrices and mouth rinses adds considerable fluoride, often approaching or exceeding that from diet, particularly in young children who have poor control of the swallowing reflex. Although exposure from professionally applied products (e.g., rinses and gels with high fluoride concentrations) occurs less frequently, such products also contribute to fluoride intake.

Desensitizing Dentin

Sodium fluoride and acidulated phosphate fluoride are used topically to desensitize exposed root surfaces of teeth. It has been suggested that the effectiveness of topical fluoride therapy for this condition may be increased by concomitant iontophoresis, but the efficacy of this procedure has not been established.

Bone Diseases

Sodium fluoride is used orally to increase bone density and relieve bone pain in the treatment of various metabolic and neoplastic bone diseases.

Oral administration of sodium fluoride (30-100 mg daily), in conjunction with calcium and vitamin D or calcium and estrogen, has been effective in reducing skeletal fracture rates in patients with osteoporosis. However, further study is needed to evaluate the efficacy of sodium fluoride for the treatment of osteoporosis compared with treatment with estrogens, calcium, and vitamin D and to determine which patients may respond to sodium fluoride treatment.

Although results of some studies are conflicting, oral sodium fluoride (100-200 mg daily), alone or in conjunction with calcium carbonate, has been used with some success as an adjunct in the management of bone lesions in multiple myeloma.

Although placebo-controlled studies are lacking, oral sodium fluoride (100 mg daily) reportedly reduces bone pain in patients with metastatic prostatic carcinoma. Oral sodium fluoride (25-60 mg daily) has been reported to stabilize the progression of hearing loss in a limited number of patients with otosclerosis.

There is some evidence that oral sodium fluoride (e.g., 20-30 mg daily as an extended-release preparation) can increase spinal but not femoral neck bone mineral density (BMD) in patients with corticosteroid-inducedosteoporosis. However, controlled studies are needed to elucidate further the potential efficacy of the drug in patients with this condition, and other therapies currently are preferred (e.g., calcium, vitamin D, gonadotrophic hormone replacement) for the prevention and treatment of this condition.

Dosage and Administration

Fluorides are administered orally as sodium fluoride or topically directly onto teeth as sodium fluoride, acidulated phosphate fluoride, sodium monofluorophosphate, or stannous fluoride.

To minimize the risk of fluorosis and the amount of fluoride swallowed and absorbed systemically, children younger than 12 years of age should be instructed and/or supervised carefully regarding proper techniques for use of topical fluoride preparations (e.g., rinsing solutions, gels, dentifrices). When using fluoride-containing dentifrices in children 2-6 years of age, only a pea-sized amount (approximately 0.25 g) of dentifrice should be applied to the toothbrush no more often than twice daily, and the child should be instructed not to swallow the toothpaste. Unless the rinsing solution also is being used to provide oral fluoride supplementation, rinsing solutions should not be swallowed after administration but should be expectorated once rinsing is complete.

Patients receiving fluoride powders or concentrated rinsing solutions should be advised that the preparation must be reconstituted and/or diluted as directed prior to use. Patients receiving fluoride treatment gels or rinsing solutions for self-administration should be advised that these preparations are to be used as directed and should not be used as dentifrices or mouthwashes/gargles, respectively.

Oral Fluorides

To provide protection against dental caries, fluoride preferably should be provided by fluoridation of public water supplies. Oral fluoride supplements should be administered only when community fluoridation programs are not available or feasible and when the fluoride ion concentration in drinking water is 0.6 ppm (mg/L) or less.

Sodium fluoride is administered orally as solutions or tablets. Sodium fluoride oral solutions may be administered undiluted or mixed with cereal, fruit juice, or other foods. Because erupted teeth also benefit from topical fluoride, chewable tablets should be dissolved in the mouth or chewed before swallowing and should preferably be administered at bedtime after brushing the teeth.

Dosage of sodium fluoride is expressed in terms of fluoride ion. Dosage of oral fluoride supplements varies according to the age of the child. To avoid dental fluorosis, dosage also must be adjusted in proportion to the amount of fluoride ion provided in drinking water. Other sources of fluoride also should be considered.

The usual oral dosage of fluoride ion for children who live in areas where the fluoride ion concentration in drinking water is less than 0.3 ppm (mg/L) is 0.25 mg daily from 6 months to younger than 3 years of age, 0.5 mg daily for children 3 to younger than 6 years of age, and 1 mg daily for children 6-16 years of age. The usual oral dosage for children who live in areas where the fluoride ion concentration in drinking water is 0.3-0.6 ppm (mg/L) is 0.25 mg daily for children 3 to younger than 6 years of age and 0.5 mg daily for children 6-16 years of age; oral fluoride supplements are unnecessary in children younger than 3 years of age who live in areas where the fluoride ion concentration in drinking water is 0.3-0.6 ppm (mg/L).

As recommended by the National Academy of Sciences (NAS), the estimated adequate daily dietary intake of fluoride is 3.1-3.8 mg in adults 19 years of age and older and 0.01 and 0.5 mg in infants up to 6 months of age and 7-12 months of age, respectively. The estimated safe and adequate daily dietary intake of fluoride is 0.7, 1.1, 2 and 2.9-3.2 mg in children 1-3, 4-8, 9-13, and 14-18 years of age, respectively. The NAS states that the upper level for the dietary intake of fluoride should not be routinely exceeded, since the amount of fluoride necessary to produce acute toxicity may be only slightly greater than recommended adequate intakes. Because of the risk of dental fluorosis, tolerable upper intake levels recommended by NAS are 0.7, 0.9, 1.3, and 2.2 mg daily for children 0-6 months, 7-12 months, 1-3 years, and 4-8 years of age, respectively. For older children and adults in whom dental fluorosis usually is unlikely, including pregnant or lactating women, the tolerable upper limit recommended by NAS is 10 mg daily, since clinically apparent skeletal fluorosis can occur in this age group at such daily intakes over several years.(See Cautions: Skeletal Fluorosis.) The risk of skeletal fluorosis may be increased in malnourished individuals living in hot climates or tropical areas.

Topical Fluorides

Sodium Fluoride

Sodium fluoride is applied topically to teeth as a 2% solution, 2% foam, 1.1% cream, 1.1% gel, or as a rinsing solution containing 0.05 or 0.2% sodium fluoride. Sodium fluoride also is applied topically to teeth in low concentrations in appropriately formulated dentifrices.

In adults and children 6 years of age or older, rinsing solutions containing 0.05% (10 mL) or 0.2% (10 mL) of sodium fluoride generally are self-administered once daily or weekly, respectively, preferably at bedtime after thoroughly brushing the teeth. The solutions should be rinsed around and between the teeth for 1 minute and then expectorated. Patients should be instructed not to swallow the solution and, for maximum benefit, should not eat, drink, or rinse their mouth for at least 30 minutes after using the rinsing solution.

In adults and children 6 years of age or older, gels containing 1.1% sodium fluoride generally are administered daily, preferably at bedtime after thoroughly brushing the teeth. The gel should be applied in a thin ribbon to the teeth using a toothbrush or mouth trays for at least one minute and then expectorated. Patients should be instructed not to swallow the gel. Children 6-16 years of age should be instructed to rinse their mouth thoroughly after expectorating. For maximum benefit, adults should not eat, drink, or rinse their mouth for at least 30 minutes after using the gel.

In adults and children 6 years of age or older, sodium fluoride gel containing 0.5% fluoride ion (e.g., Thera-Flur-N Gel-Drops) is applied once daily to the teeth by means of trays or mouthpiece applicators. About 4-8 drops of the gel should be placed in the trough of an applicator and the applicator placed over the upper and lower teeth at the same time. The patient should bite down lightly for 6 minutes, and then remove the applicator and rinse.

In adults and children 6 years of age or older, creams containing 1.1% sodium fluoride generally are administered once daily, preferably at bedtime. The cream should be applied in a thin ribbon to a toothbrush; the patient should brush their teeth thoroughly for 2 minutes and then expectorate. Patients should be instructed not to swallow the cream. Children 6-16 years of age should be instructed to rinse their mouth thoroughly after expectorating. For maximum benefit, adults should not to eat, drink, or rinse their mouth for at least 30 minutes after brushing.

Sodium fluoride 2% solutions can be applied topically to the teeth by dental personnel. Although such application previously was commonly employed, particularly for administration in school or other public health programs, such use generally has been replaced by use of acidulated phosphate fluoride. If a 2% solution of sodium fluoride is used, the teeth should be cleaned thoroughly, isolated with cotton rolls, and dried with compressed air prior to topical application. The crowns of the teeth should then be thoroughly wetted with the solution and the solution allowed to remain in contact with the teeth for 3-5 minutes. A saliva ejector should be used to ensure that the surfaces being treated are not contaminated with saliva. The maximum protective effect appears to be obtained with a treatment series of 4 applications of 2% sodium fluoride solution given at intervals of several days following a single prophylaxis. One previously recommended regimen included administration of these treatment courses to children at 3, 7, 11, and 13 years of age if indicated because of inadequate fluoride ion concentration in drinking water.

Sodium fluoride 2% foam can be applied topically to teeth by dental personnel by means of trays or mouthpiece applicators. Some clinicians recommend use of 5 mL per application in adults, with a maximum daily dosage of 10 mL.

For desensitizing exposed root surfaces, 0.2% sodium fluoride rinsing solutions should be used once nightly after brushing and flossing at bedtime. The solution should be rinsed over the affected areas for 1 minute and then expectorated. A paste containing 33.3% sodium fluoride also has been applied topically for this condition.

Acidulated Phosphate Fluoride

Acidulated phosphate fluoride is applied topically to the teeth in the form of solutions, foams, or gels. Following application of acidulated phosphate fluoride gel, foam, or rinsing solution, the patient should not eat, drink, or rinse his mouth with water for 30 minutes.

In adults and children 6 years of age or older, acidulated phosphate fluoride gels containing 0.5% fluoride ion (e.g., APF Gel, Karigel Maintenance APF Gel, Phos-Flur Gel) generally are administered daily, preferably at bedtime after thoroughly brushing the teeth. The gel should be applied in a thin ribbon to the teeth using a toothbrush or mouth trays for at least one minute and then expectorated. Patients should be instructed not to swallow the gel. Children 6-16 years of age should be instructed to rinse their mouth thoroughly after expectorating. For maximum benefit, adults should not eat, drink, or rinse their mouth for at least 30 minutes after using the gel.

Acidulated phosphate fluoride rinsing solutions containing 0.02% fluoride ion (e.g., Phos-Flur) are self-administered, preferably after thoroughly brushing the teeth. The usual dosage of acidulated phosphate fluoride rinsing solution containing 0.02% fluoride ion is 10 mL daily for adults and children 6 years of age or older, preferably at bedtime. The solution should be rinsed around and between the teeth for 1 minute and then expectorated. When a 0.02% solution is recommended by dental or medical professionals to provide a supplemental oral dosage of fluoride in children 3 years of age and older, the solution should be used as an oral rinse and then swallowed; 5 mL of the solution should be used by children 3-14 years of age who live in areas where the fluoride ion concentration in drinking water is less than 0.3 ppm (mg/L), and 2.5 mL should be used by children 3-14 years of age who live in areas where the fluoride ion concentration is 0.3-0.6 ppm (mg/L).

Acidulated phosphate fluoride topical gels or foams containing 1.2 or 1.23% fluoride ion are generally applied to the teeth by dental personnel every 6-12 months. In patients with rampant caries, treatments may be repeated once or twice every 6 months.

For desensitizing exposed root surfaces of teeth, a few drops of acidulated phosphate fluoride gel containing 0.5 or 1.2% fluoride ion should be applied to a toothbrush and brushed onto the affected areas each night after brushing and flossing at bedtime. Sensitivity usually is relieved within a few weeks.

Stannous Fluoride

Stannous fluoride is applied topically to the teeth by dental personnel as a 0.4% gel, after thoroughly brushing the teeth. Patients should be advised not to eat, drink, or rinse their mouth with water for 30 minutes following treatment.

In adults or children 12 years of age and older, 0.4% stannous fluoride gels (e.g., Gel-Kam) are administered once daily, after brushing and flossing the teeth, for prevention of dental caries. After shaking the toothbrush to remove excess water, the gel should be applied to cover the bristles; the patient should brush thoroughly, allow the gel to remain on the teeth for 1 minute, and then expectorate. For sensitivity relief, the gel should be administered twice daily (morning and evening) or as recommended by a clinician, using a toothbrush or cotton swab to make certain that all sensitive areas are covered with the gel.

In adults and children 12 years of age or older, 0.63% stannous fluoride rinsing solutions (e.g., Gel-Kam) are administered at least once daily, preferably following regular brushing and flossing of the teeth. The usual dosage of 0.1% rinsing solution should be prepared from the concentrate by pouring the concentrated rinse (0.63%) to the 1/8-oz mark (bottom mark) of the mixing vial and adding water to the 1-oz mark; the resulting solution should be mixed and used immediately. One-half of the solution (0.5 oz) should be rinsed around and between the teeth for 1 minute and then expectorated. This rinsing procedure should be repeated with the remaining solution (0.5 oz). The manufacturer's prescribing information should be consulted for information on preparation and use of the concentrated solution with home irrigators.

Stannous fluoride also is self-administered topically to teeth in low concentrations in appropriately formulated dentifrices.

Cautions

Effects on Teeth

Prolonged daily ingestion of excessive amounts of fluoride during the period of tooth development results in varying degrees of dental fluorosis; children approximately 2-3 years of age appear to be most vulnerable to fluorosis of the permanent teeth. Dental fluorosis, or mottled enamel, is characterized by markings of hypocalcification or hypocalcification and hypoplasia, and the extent of fluorotic changes is dose dependent. Fluorosed enamel has a high protein content, resulting in increased porosity; in moderate to severe forms of fluorosis, the teeth eventually become stained and pitted. Milder forms of fluorosis are characterized by opaque striations that run horizontally across the tooth surface; the striations may become confluent, resulting in white opaque patches, and such changes often are most apparent on the incisal edges of anterior teeth or cusp tips of posterior teeth (''snow capping''). Mild fluorosis has no effect on tooth function and actually may render the enamel more resistant to caries. Even in more advanced forms of enamel fluorosis, the adverse effect generally is considered cosmetic rather than functional. However, the degree of cosmetic change can be extensive, presenting in moderate to severe forms as aesthetically objectionable changes in tooth color and surface irregularities.

When the fluoride ion content of drinking water is 1 ppm (mg/L) or less, faint white flecks on the teeth may occasionally occur. Brownish spots develop on many teeth in most individuals when the fluoride ion content of drinking water is greater than 2 ppm (mg/L), and the enamel has a darker discoloration and loses its smoothness when the fluoride ion content of drinking water is greater than 2.5 ppm (mg/L). Dental fluorosis is the most sensitive index of chronic fluoride poisoning. Dental fluorosis generally does not occur when oral or topical fluoride supplements are administered in the recommended dosages or when excessive amounts of fluoride are ingested after the teeth have developed. Therefore, because the preeruptive maturation of crowns of anterior permanent teeth is complete by 8 years of age, the risk of enamel fluorosis is of greatest concern in children younger than 8 years of age.

Staining or pigmentation (e.g., yellow, brown, brown-black) of the teeth resulting from topical application of concentrated solutions or gels of stannous fluoride has been reported, particularly in patients with poor oral hygiene. The pigmentation, which is probably stannous sulfide, is generally associated with a carious lesion or a hypocalcified area of the enamel or with plaque or accumulated debris, or occurs at the margin of a silicate restoration. Staining also has occurred with stannous fluoride-containing dentifrices, but the risk of staining with these dentifrices appears to be less than that with stannous fluoride-containing solutions or gels because the latter preparations do not contain abrasives, they are in contact with teeth for longer periods of time after application, and the mouth is not rinsed with water after application. To minimize the risk of staining, individuals receiving stannous fluoride-containing preparations should be advised of the importance of good oral hygiene (e.g., adequate brushing). These individuals also should be advised that such staining is not harmful or permanent and can be removed by a dentist or dental hygienist.

Sensitivity Reactions

Allergic rash and other idiosyncratic reactions have been reported with oral and topical sodium fluoride preparations. Urticaria, exfoliative dermatitis, atopic dermatitis, stomatitis, and GI and respiratory allergic reactions have occurred rarely following the use of dentifrices or multivitamin preparations containing fluoride.

In patients with mucositis, gingival tissue may be hypersensitive to alcohol or other ingredients contained in some oral or topical sodium fluoride preparations.

Skeletal Fluorosis

The principal adverse functional effect of excess fluoride intake is skeletal fluorosis. Prolonged intake of drinking water that contains a fluoride ion concentration of 4-8 ppm (mg/L) infrequently has resulted in an increase in the density of bone mineral to a degree detectable by radiographic studies, and apparent fluoride osteosclerosis has been reported. In one study, however, such intake resulted in 23 cases of osteosclerosis but no evidence of skeletal fluorosis in 170,000 surveyed radiographs. In tropical areas, relatively marked osteofluorotic changes have been associated with drinking water fluoride concentrations of only 3 ppm (mg/L) and were attributed to poor nutrition, hard manual labor, and high levels of water intake. Therefore, the risk of skeletal fluorosis may be increased in malnourished individuals living in hot climates or tropical areas.

In the asymptomatic, preclinical stage, skeletal fluorosis manifests as slight radiographically detectable increases in bone mass, bone ash fluoride concentrations ranging from 3.5-5.5 g/kg, and bone fluoride concentrations that are 2-5 times higher than those of life-long residents of communities with optimally fluoridated water supplies. Stage 1 skeletal fluorosis is characterized by occasional joint stiffness or pain and some pelvic and vertebral osteosclerosis; bone ash concentrations usually range from 6-7 g/kg. In stages 2 and 3, potentially crippling changes may include dose-related calcification of ligaments, osteosclerosis, exostoses, possibly osteoporosis of long bones, muscle wasting, and neurologic defects secondary to vertebral calcification; bone ash concentrations exceed 7.5-8 g/kg.

The risk of developing skeletal fluorosis is related directly to the extent and duration of fluoride exposure, and crippling skeletal fluorosis is extremely rare in the US. Manifestations of milder forms of skeletal fluorosis generally require a fluoride intake of at least 10 mg daily for at least 10 years. Advanced stages of skeletal fluorosis are associated with fluoride intakes ranging from 20-80 mg daily for at least 10 years. At least one case of severe joint pain and stiffness was attributed to fluoride intake of about 50 mg daily for 6 years.

Other Adverse Effects

Laboratory tests indicate that use of acidulated phosphate fluoride may cause dulling of porcelain and ceramic restorations; therefore, use of neutral sodium fluoride solutions may be recommended for patients with these restorations.

Adverse GI effects including GI bleeding, nausea, and vomiting have been reported in patients receiving 40-65 mg of sodium fluoride daily for the treatment of osteoporosis. When large doses of sodium fluoride are used, nausea may be reduced by administering the drug with or immediately following meals.

Adverse rheumatic effects such as synovitis and a plantar fascial syndrome characterized by diffuse pain and tenderness of the plantar portion of one or both feet have been reported in patients receiving an oral sodium fluoride dosage of 40-65 mg daily.

Precautions and Contraindications

Because prolonged ingestion of high doses of fluoride may result in dental fluorosis and osseous changes, the recommended dosage of oral and topical fluoride preparations should not be exceeded, and dosage should be adjusted in proportion to the amount of fluoride ion present in drinking water. In addition, proper techniques for applying topical fluoride preparations should be followed to minimize the amount of fluoride that is swallowed and absorbed systemically.(See Dosage and Administration.)

Sodium fluoride and acidulated phosphate fluoride oral solutions and sodium fluoride oral tablets are contraindicated for use as dietary supplements when the fluoride ion concentration in drinking water is greater than 0.6 ppm (mg/L). Sodium fluoride tablets containing 1 mg of fluoride ion should not be used in children younger than 6 years of age and are contraindicated when the fluoride ion concentration in drinking water is 0.3 ppm (mg/L) or greater.

Because young children usually cannot perform the rinse process necessary with oral rinsing solutions, sodium fluoride and acidulated phosphate fluoride oral rinsing solutions generally should not be used in children younger than 6 years of age, unless otherwise directed by a dentist or physician; children 6-12 years of age should be instructed and/or supervised carefully regarding the proper use of these preparations. Similar precautions should be followed with topical fluoride gels and creams in these age groups. Oral rinsing solutions and topical gels containing stannous fluoride generally should not be used in children younger than 12 years of age, unless otherwise directed by a dentist or clinician. To minimize the risk of dental fluorosis, children 2-6 years of age should be instructed and/or supervised carefully regarding the proper use of dentifrices containing fluorides.

Oral or topical fluoride preparations are contraindicated in individuals who are hypersensitive to fluoride.

Pharmacokinetics

Absorption

Sodium fluoride and other soluble fluoride salts are readily and almost completely absorbed from the GI tract. The absorption of fluoride from ingested toothpaste containing sodium fluoride or sodium monofluorophosphate (MFP) also appears to be almost complete. A substantial portion of an oral dose of soluble fluoride may be absorbed in the stomach, and the rate of absorption may depend on gastric pH. If fluoride is administered orally as a less soluble salt (e.g., calcium fluoride) or as bone meal, absorption of fluoride is slow and variable. Oral absorption of fluoride may be decreased by simultaneous ingestion of magnesium or aluminum hydroxide. Simultaneous ingestion of calcium also may decrease absorption of large doses of fluoride since calcium fluoride, which is poorly absorbed, may be formed in the GI tract. However, simultaneous ingestion of dairy products containing calcium probably has little effect on absorption of the low concentrations of fluoride present in drinking water. In the absence of high dietary concentrations of calcium and certain other cations, 80% or more of a dose of soluble fluoride probably is absorbed from the GI tract. When administered concomitantly with milk, infant formula, or foods, especially those with high concentrations of calcium or certain other divalent or trivalent cations that form insoluble fluoride salts, absorption of fluoride may be reduced by 10-25%. Although some studies suggested that oral bioavailability of fluoride may increase with concomitant administration of caffeine or other methylxanthines, other studies failed to confirm this finding.

Normal total plasma fluoride concentrations have been reported to range from 0.14-0.19 mcg/mL, of which 15-20% is ionized. Ionic fluoride is the physiologically important form in plasma. The source(s), physiologic importance, and fate of nonionic fluoride (e.g., perfluoro-octanoic acid) present in plasma is not known, but conversion of nonionic to ionic fluoride in plasma does not appear to occur.

Distribution

Following absorption, fluoride is stored in bones and developing teeth. Skeletal tissue has a high storage capacity for fluoride ions and a storage-mobilization mechanism in skeletal tissue maintains a low level of fluoride in the body which may be important in providing a constant supply of fluoride for developing teeth. Although body and tissue concentrations of fluoride are proportional to the chronic level of intake, they are not homeostatically controlled. Because of their small mass, teeth serve as storage sites for only a small fraction of fluoride retained in the body; however, fluoride deposited in teeth is not readily released. The highest concentration of fluoride in dental enamel is present in the outer surface, with the next highest concentration occurring at the dentinoenamel junction.

Although fluoride has been detected in all organs and tissues, very little fluoride accumulates in noncalcified tissues. About 99% of total body fluoride is strongly but not irreversibly bound in calcified tissues. Bone fluoride appears to exist in both a rapidly and slowly exchangeable pool. The rapidly exchangeable bone pool is located in the hydration shells of bone crystallites, where fluoride may be exchanged isoionically or heteroionically with ions in the surrounding extracellular fluid. Mobilization from the slowly exchangeable pool results from resorption associated with bone remodeling. Fluoride concentrations in parotid and submandibular ductal saliva are about 70-90% those in plasma, and concentrations in whole saliva exceed those in ductal saliva. Small amounts of fluoride are distributed into sweat, tears, and hair.

Fluoride crosses the placenta and is distributed into milk. Fluoride concentrations in milk are reported to range from less than 0.05 ppm (mg/L) to 0.13 ppm (mg/L) and generally remain constant regardless of the fluoride concentration in the woman's serum or drinking water. In one study, the concentration of fluoride in milk ranged from 2-8 ng/mL prior to and up to 2 hours after oral administration of a single 1.5-mg dose of sodium fluoride. However, fluoride concentration in milk may be increased when the daily dose of fluoride is greater than 1.5 mg.

Elimination

Fluoride is rapidly excreted principally in urine, although small amounts are excreted in feces. About 90% of fluoride is filtered by the glomerulus and is reabsorbed to a variable degree by the renal tubules; it is not known if tubular secretion of fluoride occurs. The extent of renal tubular reabsorption of fluoride is inversely related to tubular fluid pH. The renal clearance of fluoride in adults is about 30-40 mL/minute. The clearance of fluoride from plasma is about 75 mL/minute in healthy adults, which is approximately equivalent to the sum of renal and calcified tissue clearances of the ion.

The fractional retention or balance of fluoride depends on age-dependent quantitative characteristics of absorption and excretion. Under most dietary conditions, fluoride balance is positive. However, when fluoride intake is inadequate to maintain or gradually increase plasma fluoride concentrations, fluoride excretion can exceed the amount ingested secondary to mobilization from calcified tissues. For healthy young or middle-aged adults, about 50% of absorbed fluoride is retained by uptake in calcified tissues, with the remainder being excreted in urine. In young children, up to 80% of absorbed fluoride can be retained secondary to increased uptake by developing teeth and bone. Based on bone mineral dynamics, it is likely that the fraction of absorbed fluoride that is excreted exceeds the fraction retained in older adults.

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