fluoride varnish in children

What is it?

            “Dental caries comprise the single most common chronic disease affecting children in the United States today,” (Lewis et al., 2000). While education and preventative visits to a dentist have certainly reduced the number of incidences, the issue remains a prominent one.

            Professionally applied topical fluoride agents, for practical purposes, utilize high fluoride concentrations to deposit considerable amounts of fluoride in short periods of time. Fluoride varnish is one such agent as a simple, effective professionally applied topical agent.

            Duraphat, marketed by Colgate Oral Pharmaceuticals, yields 2.26 percent fluoride from a suspension of sodium fluoride in an alcoholic solution of natural varnish substances in colophonium base and has been restricted to use on sensitive teeth by the FDA (Vaikuntam, 2000).

            Duraflor, marketed by Medicom, “is similar to Duraphat in formulation and contains 5% sodium fluoride varnish in an alcoholic suspension of natural resins.”  They have also added xylitol for sweetness, allowing for more customer satisfaction.  It is, however, less viscous than Durphat (Vaikuntam, 2000).

            Fluor Protector, marketed by Ivoclar of Amherst, NY, derives from “a polyurethane base with 1% difluorosilane”.  Less viscous than either of the afore mentioned products, Fluor Protector has a lower ph than Duraphat as well (Vaikuntam, 2000).

            Cavity Shield, marketed by Omnii Products of Florida, is the newest product available.  “A 5% sodium fluoride varnish in a resinous base, each millimeter contains 50mg NaF.”  Unit-dosed, its greatest asset thus far is the improvement on cost-effectiveness, correct dosage, and prevention of over-ingestion (Vaikuntam, 2000).

History

            In the early 1970s, fluoride varnishes developed out of the drive to improve on current methods of fluoride use. This method, brought to Europe first, prolonged the contact time of fluoride with tooth enamel. “In Denmark, for example, more than 90 percent of municipal caries-preventative programs provided fluoride varnish to children up through 18 years of age” (Beltran-Aguilar & Goldstein, 2000).

            First approved by the United States Food and Drug Administration in 1994 (Beltrane-Aguilar & Goldstein, 2000), the process has also been endorsed by the American Dental Association (Beltran-Aguilar & Goldstein, 2000).

            The FDA considers use of the varnish “off-label” though not illegal. “If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects” (1998).

            The poor and minority groups of this country have traditionally been in a substandard slot for health care. Dental hygiene is no exception to this rule. Charlotte Lewis and peers have sited a study from the national Institute of Dental and Craniofacial Research, which states “80% of caries occur in only 25% of children. Latino, American Indian and Alaska Natives are at especially high risk for developing early childhood caries, sometimes called ‘baby bottle tooth decay’” (2000).

            All clinical trials use children as the subjects and show an average improvement of 38% in “caries reductions to permanent teeth” based on a meta-analysis conducted by Helfenstein and Steiner (Beltran-Aguilar & Goldstein, 2000).

Safety

            Due to the high concentration of the fluoride content in varnishes, many are concerned with the safety of the patient – particularly the children. “Over-application is a common occurrence and one must be careful to apply just the required amount on the tooth surface” (Vaikuntam, 2000).

            Home application is possible, but since a professional is not present in these cases to ensure proper drying time, thus consuming larger doses of the fluoride through salivation. Going to licensed professionals for the application will significantly reduce this risk.

            “In addition, as fluoride is released from the varnishes after treatment, some fluoride will be ingested” (Beltran-Aguilar & Goldstein, 2000). The same study indicated that the higher amount of peak fluoride concentrations in the blood stream of children came immediately following the application, with decreasing levels the longer the varnish was on the teeth. The data was comparable similar to those found in fluoridated toothpaste, fluoride tablets and considerably lower than those using the fluoride gels (Beltran-Aguilar & Goldstein, 2000).

            “Two cases of contact allergy to Duraphat varnish have been reported.” One case was a skin-related reaction and the other was a “stomatitis” in a patient. Both are believed to be related to the colophony base of the varnish (Beltran-Aguilar & Goldstein, 2000).

            With proper training and attention to detail while utilizing the varnish- many of the risks associated with the application can be avoided. Parents need to be reminded of the protocol prior to the first meal, thereby allowing the child the best possible situation to inhibit over-ingestion the first place.

            Cavity Shield offers a promising future in eliminating the risk factor and improving the over all safety of this procedure.

Application

            Following a thorough cleaning of the teeth, they are then dried with cotton.  Most varnishes set in wet conditions, so complete drying is not necessary. Following application instructions, the proper amount of varnish is then applied and allowed to dry. The application times seem to vary according to each study (Vaikuntam, 2000).

            Duraphat and Duraflor set leaving a brownish-yellow sheen that will dissipate after daily brushing recommences.

            Some apply twice a year, some four times a year and others three times within one week.  “It is important to stress that for fluoride varnishes to be effective, reapplication is necessary” (Vaikuntam, 2000). This reapplication process allows for filling of any spaces that may not have adhered properly to the tooth allowing for caries to continue their destruction.

            Follow-up includes no “drink for at least two hours or chew for the next four hours and to avoid rough, hard food for the next 24 hours” (Autio-Gold & Courts, 2001).  As saliva is the main carrier of the fluoride into the blood stream, these directions are important to avoid ingestion.

            The cost of application varies per product used. Duraphat runs $25.00 per 10 ml tube averaging $1-$2 per application. Duraflor is similar at $24-$28 per 10 ml tube. Fluor Protector and Cavity Shield are based on a single dose price, averaging $3-$4 per dose (Vaikuntam, 2000). Obviously, the latter two choices incur more cost but single doses reduce the risk of over-application and contamination.

            The actual cost of the procedure may be a deterrent for some patients, although Medicaid’s Early Periodic Screening Diagnosis and Treatment (EPSDT) will foot the bill.  Some patients still have difficulty if they are uninsured or if their insurance provider disputes the need.

Patient Acceptance

            Patient acceptance comes in three forms – the first is to get them into the office or clinic for check-ups and preventative care. This is by far the first hurdle in getting the treatment to those who need it most, the poor. “Despite higher rates of decay, poor children had one half the number of dental visits, compared with higher income children in 1996” (Lewis, et al., 2000).

            Secondly, costs must factor into the equation, as the line of economical demarcation can be a strong one.  “North Carolina Medicaid is currently piloting a program to reimburse physicians to provide oral health anticipatory guidance and fluoride varnish to children under the age of three” (Lewis et al., 2000).  This will only help to facilitate the disbursement of treatment among the poor.

            Lastly, the patient must be receptive to the intended treatment. “Varnish is still far preferred for treatment of infants and children, running a far reduced risk of over-ingestion when compared to APF gels. Not to mention they are more pleasing to taste, thereby making a prevention children are apt to allow and cooperate with (Bawden, 1998).

            As mentioned earlier, Duraflor uses xylitol in its product, making the taste more appealing for patients. “Xylitol reduces the growth and acid production of Streptococcus mutans, which is the most important bacterium in the pathomechanism of dental caries” (Isokangas et al., 1988). This may be a step toward bettering the experience, making people less adverse to the treatment, while improving overall conditions.

            So how can we disseminate the information regarding the effectiveness of fluoride varnishes? Studies have shown that the use of this treatment far outweighs the other means of providing fluoride to patients. Although the immediate costs will remain the main prohibitive factor, in the end prevention always saves money.

Conclusion

            “Varnish offers considerable advantages in the dental public health setting.  Of particular note, it is practical and safe to apply to the teeth of infants and very young children” (Bawden, 1998).

            Keeping that in mind, one must continue to enhance the environment of its use, and head off current and future issues that could be under our control.

            Costs range near the more common vehicles of fluoride carriage, to include tablets, fluoridated water and APF gels, but with the onset of demand and increased usage, these costs will decline.

            Further advancements and innovations provided by Medicaid and other insurance providers will increase the viability of fluoride varnish as a preventative treatment.

            All dental practitioners must be educated in the proper application and use of varnish. This detail in the beginning will prevent over-application and ingestion of the fluoride, and thereby their harmful effects.

            Educating patients about the great value found in this treatment will further the usage.  Further improvements on the flavor, such as the use of xylitol or other flavor enhancements, will increase the ease of use with pediatric patients.

References

Autio-Gold, J.T., & Courts, F. (2001). Assessing the effect of fluoride varnish on early enamel carious lesions in the primary dentition. Journal of the American Dental Association, 132, 1247-52.

Bawden, J.W. (1998). Fluoride varnish: A useful tool for public health dentistry. Journal of Public Health Dentistry, 58, 266-9.

Beltran-Aguilar, E.D., Goldstein, J.W., & Lockwood, S.A. (2000). Fluoride varnishes: A review of their clinical use, cariostatic mechanism, efficacy and safety. Journal of the American Dental Association, 131, 589-96.

Isokangas, P., Alanen, P., Tiekso, J., & Makinen, K.K. (1988). Xylitol chewing gum in caries prevention: A field study in children. Journal of the American Dental Association, 117(2), 315-320.

Lewis, C.W., Grossman, D.C., Domoto, P.K., & Deyo, R.A. (2000). The role of the pediatrician in the oral health of children: A national survey. Pediatrics, 106, 84-90.

United States Food and Drug Administration. (1998). “Off-Label” and Investigational Use
Of Marketed Drugs, Biologics, and Medical Devices. Retrieved October 11, 2006 from http://www.fda.gov/oc/ohrt/irbs/offlabel.html

Vaikuntam, J. (2000). Fluoride varnishes: Should we be using them? Pediatric Dentistry, 26, 513-6.