Stannous fluoride is a topically administered fluoride preparation. Although water contains fluoride ions, natural water in some areas has a very low fluoride concentration. Topical fluorides, such as toothpastes, mouth rinses, gels, and foams, strengthen teeth already present in the mouth by making them more decay-resistant. In contrast, systemic fluorides, such as tablets, fluoridated water, lozenges, and drops, are ingested, incorporated into forming teeth, and distributed into saliva, which continually bathes the teeth. In addition to stannous fluoride, sodium fluoride and acidulated phosphate fluoride are commercially available topical fluoride preparations. Products vary in the percentage of fluoride ion provided per unit of measure. Fluoride, an important mineral, is the ionic form of fluorine. The negatively charged fluoride combines with positively charged calcium or sodium ions to form stable compounds. Fluoride reduces cavity development in both children and adults. Fluoride also helps repair the early stages of tooth decay even before the decay becomes visible. Stannous fluoride was approved by the FDA in 1956.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-Stannous fluoride is applied to the teeth in the form of gels, mouth rinses, or toothpaste. Instruct patient on proper use of specific products (see Dosage and Patient Information).
-Children require supervision in the use of topical preparations. Stannous fluoride should not be swallowed. Avoid overuse or ingestion of any topical product.
-Patients should not eat, drink or rinse the mouth for at least 30 minutes after use.
Topical stannous fluoride preparations produce few side effects when used as directed. Care should be taken by all patients to avoid swallowing stannous fluoride. Use should generally be avoided in children. Chronic fluoride intake can produce general fluorosis with asthenia, weight loss, and anemia. Skeletal bones may also be affected, and in extreme cases become brittle. If the toothpaste, rinse, or gel is accidentally swallowed, contact a Poison Control Center. If the toothpaste, rinse, or gel is swallowed on a continuous basis, dental fluorosis may develop. Too much fluoride ingestion by children less than 8 years of age can cause mottling, staining, or hypoplasia of tooth enamel. Dental fluorosis is largely a cosmetic issue and is of most concern for children under 6 years of age. Enamel is no longer susceptible once its pre-eruptive maturation is complete.
Stannous fluoride may cause tooth discoloration or staining of natural teeth or of porcelain and ceramic denture restorations. The discoloration of natural teeth typically resolves with continued regular brushing, decreased frequency of use, or discontinuation of stannous fluoride. Patients with porcelain or ceramic dental restorations should only use neutral sodium fluoride to avoid tooth discoloration.
Dyspepsia, abdominal pain, headache, or weakness rarely occur; these symptoms may indicate the unintentional ingestion or improper use of stannous fluoride.
Excessive fluoride ingestion can result in changes in bone mineralization. Also, patients who systemically ingest excessive fluoride during dental enamel development, which typically occurs during the first 8 years of life, may experience dental fluorosis which is characterized by mottling, staining, or hypoplasia of tooth enamel. Patients who have severe dental fluorosis, characterized as pitted and brittle enamel, possibly with areas of brown staining, should not use stannous fluoride.
Stannous fluoride should not be used in neonates, infants, and children younger than 2 years; some manufacturers specifically state not to use in these populations unless recommended by a dentist or physician. The safety and effectiveness of stannous fluoride has not been established in neonates, infants or children younger than 2 years old. Children less than 6 years of age may also inadvertently swallow the gel or rinse. Topical stannous fluoride should not be swallowed. Topical fluoride products can be beneficial to children who live in areas that have an inadequate supply of fluoride in the drinking water. Information on an area's water fluoride concentration may be found at the US Centers for Disease Control website.
Stannous fluoride may cause discoloration or staining of porcelain and ceramic dental restorations. Patients with this type of dental work should use only neutral sodium fluoride.
Topical stannous fluoride preparations (e.g., gels, toothpastes, and mouth rinses) are classified as FDA pregnancy risk category B. When used as directed, topical stannous fluoride preparations are considered safe to use during pregnancy. 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. Appropriate topical application of stannous fluoride should not lead to substantial increases in maternal or fetal systemic fluoride concentrations.
Whether or not fluoride is excreted in breast milk is unknown. However, appropriate use of topical stannous fluoride preparations should not result in increased maternal systemic fluoride concentrations. Breast-feeding may result in low concentrations of fluoride in infants. In areas with non-fluoridated water, or where infant formulas are prepared with non-fluoridated water, infants may require fluoride supplementation to help prevent dental caries.
Stannous fluoride is not intended for systemic fluoride treatment; stannous fluoride topical preparations should not be swallowed. All necessary attempts to avoid accidental exposure via systemic ingestion should be taken. Ingestion of fluoride can exacerbate GI disease or ulceration and should be used cautiously in patients with gastric problems.
For dental caries prophylaxis and dentin desensitization*:
Topical dosage (0.63% stannous fluoride concentrate solution):
Adults: Pour the concentrated rinse to the 1/8 fluid ounce mark in the mixing vial, then add water to the 1 fl oz line and mix. Place one-half of the mixed solution into the mouth and vigorously swish for 1 minute, then expectorate. Repeat the one-minute treatment with the remaining solution and expectorate. Do not swallow. Do not rinse, eat, or drink for 30 minutes after use. Use once or twice daily after brushing and flossing.
Children and Adolescents 12 to 17 years: Pour the concentrated rinse to the 1/8 fluid ounce mark in the mixing vial, then add water to the 1 fl oz line and mix. Place one-half of the mixed solution into the mouth and vigorously swish for 1 minute, then expectorate. Repeat the one-minute treatment with the remaining solution and expectorate. Do not swallow. Do not rinse, eat, or drink for 30 minutes after use. Use once or twice daily after brushing and flossing.
Topical dosage (0.4% stannous fluoride gel):
Adults: Shake excess water from toothbrush and cover the bristles with gel. Brush thoroughly. Keep on teeth for 1 minute, then expectorate. Do not rinse mouth or swish with water prior to spitting out. Do not swallow the gel. Do not rinse, eat, or drink for 30 minutes after use. Use once daily after brushing and flossing for caries prevention; use twice daily for sensitivity relief.
Children and Adolescents 6 to 17 years: Shake excess water from toothbrush and cover the bristles with gel. Brush thoroughly. Keep on teeth for 1 minute, then expectorate. Do not rinse mouth or swish with water prior to spitting out. Do not swallow the gel. Do not rinse, eat, or drink for 30 minutes after use. Use once daily after brushing and flossing for caries prevention; use twice daily for sensitivity relief.
Topical dosage (Sensodyne Fluoride Toothpaste):
Adults: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice daily (morning and evening), and not more than 3 times per day. Spit out after brushing.
Children and Adolescents 12 to 17 years: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice daily (morning and evening), and not more than 3 times per day. Spit out after brushing.
Topical dosage (Parodontax Complete Protection Toothpaste):
Adults: Apply toothpaste onto a toothbrush. Brush teeth thoroughly at least twice daily, and not more than 3 times per day. Spit out after brushing.
Children and Adolescents 2 to 17 years: Apply toothpaste onto a toothbrush. Brush teeth thoroughly at least twice daily, and not more than 3 times per day. Spit out after brushing.
Maximum Dosage Limits:
-Adults
No maximum dosage information is available.
-Geriatric
No maximum dosage information is available.
-Adolescents
No maximum dosage information is available.
-Children
2 years and older: No maximum dosage information is available.
younger than 2 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears no dosage adjustments are needed.
*non-FDA-approved indication
Food: (Minor) Eating food, drinking fluid, or rinsing the mouth should be avoided for at least 30 minutes after use. Waiting to eat and drink may extend the benefits of stannous fluoride.
Fluoride reduces the incidence of dental caries and slows or reverses the progression of existing lesions, thereby helping to prevent cavity formation. Acid is formed when cariogenic bacteria in plaque break down sugars and carbohydrates from the diet. Fluoride is released from dental plaque in response to the lowered pH at the tooth-plaque interface. Saliva provides a buffering action that neutralizes plaque acids. If plaque acids are not neutralized, demineralization of the tooth occurs. Carbonated calcium hydroxyapatite largely composes dental mineral. Replacement of a portion of the phosphate in calcium hydroxyapatite with a carbonate results in carbonated calcium hydroxyapatite, which is more soluble, especially in acidic media, than calcium hydroxyapatite. Once the plaque pH is restored, remineralization can take place. The process of demineralization and remineralization is continuous over the life of the tooth. Repeated acid attacks can result in a cavity. The presence of fluoride at the site of remineralization is ideal. The released fluoride, along with the fluoride present in saliva, is taken up with calcium and phosphate by demineralized enamel to establish an improved enamel crystal structure containing fluoroapatite. Stannous fluorophosphate reacts with enamel hydroxyapatite to form fluoroapatite, which is more acid-resistant than the replaced carbonated calcium hydroxyapatite. Thus, topical fluoride use helps reduce cavity formation by transiently increasing the fluoride concentration in saliva. Also, topical fluoride application leaves a temporary layer of calcium fluoride-like material on the enamel surface. The fluoride in this calcium fluoride-like material is released when the pH in the mouth drops in response to acid production, providing fluoride to remineralize enamel. The improved enamel structure that results is more acid-resistant. In addition to helping create an improved enamel structure, fluoride presence in plaque helps reduce acid production from cariogenic bacteria by inhibiting their metabolism of carbohydrates. Fluoride also reduces cariogenic bacteria production of polysaccharides that enhance adherence of the plaque to enamel. Stannous fluoride is comparable to chlorhexidine at reducing oral bacteria, especially in periodontal pockets, and inhibiting the growth of oral bacteria commonly found in dental plaque. Stannous fluoride may also offer anti-plaque and anti-gingivitis properties. The administration of 1.64% stannous fluoride gel to sites of periodontitis has been found to reduce gingival inflammation and decrease the numbers of subgingival motile organisms for 6 to 10 weeks. Stannous fluoride has the ability to decrease dental hypersensitivity. The process is not well understood, although it is thought to be related to the mechanism by which stannous fluoride prevents and reduces caries. There is also evidence that efficacy is due to the occlusion of tubules on the tooth surface by hydrated tin oxide, a byproduct of the reaction of stannous fluoride with enamel hydroxyapatite.
Stannous fluoride is administered topically to the teeth. Fluoride is more readily taken up by demineralized enamel than by intact enamel. Stannous fluoride produces calcium fluoride, stannous fluorophosphate, and hydrated tin oxide. Unlike sodium fluoride, both the anion and the cation of stannous fluoride react with enamel hydroxyapatite, and there is no loss of phosphate ions. Most of the fluoride in teeth is concentrated in dental enamel, and secondly at the dentinoenamel junction. Systemic absorption of properly used stannous fluoride is minute and insignificant. Systemic absorption of improperly used stannous fluoride can be significant. Absorption from the GI tract is rapid and almost complete. Ionic fluoride is the pharmacologically active form, and 15 to 20% of plasma fluoride is ionized. Once absorbed, fluoride is stored in bones and teeth. Skeletal tissue has a high capacity for storage of fluoride ions, and is responsible for maintaining a low level of fluoride in the body. Teeth represent a small repository of fluoride because of their relatively small mass. Fluoride in teeth is not readily released. Serum fluoride concentrations of 5 to 10 micromol/L are believed to be therapeutic.
-Route-Specific Pharmacokinetics
Oral Route
The intra-oral pharmacokinetics of topically applied fluoride have not been well described. For example, the desirability of occasional high fluoride peaks of short duration in the oral cavity versus smaller, more frequent peaks is unknown.