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Tarheel Varnish

Feb. 1, 2000
North Carolina program focuses on fluoride varnish to prevent caries among rural Appalachian children.

North Carolina program focuses on fluoride varnish to prevent caries among rural Appalachian children.

Cathleen Terhune Alty, RDH

Smart Smiles is a three-year pilot program underway in the rural western part of North Carolina. The program targets children between the ages of nine months and three years who have a high caries risk. Smart Smiles is designed to promote good dental health through consumer education and the prevention of decay by applying a fluoride varnish.

Douglas Sailer, community development director for the North Carolina Partnership for Children and regional administrator for the program, said the program came as a regional response from local Smart Start partnerships. "The local Smart Start nonprofit organizations in western North Carolina identified dental health as a priority need for pre-school-aged children. The Smart Smiles pilot project was then created in collaboration with local partnerships for children, the North Carolina Dental Health Section, The Ruth and Billy Graham Children`s Health Center, and the University of North Carolina Schools of Dentistry and Public Health."

Sailer noted, according to national statistics, a general improvement in the oral health status of children. Yet, in certain subgroups such as children 5 years old and younger, he said dental caries remains one of the major health problems in the United States. Research links early childhood caries to low socio-economic status. In North Carolina, about 31,000 or 40 percent of children in kindergarten suffer from early tooth decay. He emphasized that the pilot program is focusing on children with the greatest potential for disease.

Eleven counties in the Appalachian region of North Carolina were selected to be in the study because of the high prevalence of early childhood caries. The program treatment package includes oral hygiene instruction, education for both the caregiver and medical personnel, a nondiagnostic dental screening for obvious caries, and the application of a fluoride varnish.

The program has some unique features. According to Dr. James W. Bawden, former dean of the dental school at the University of North Carolina and who has been involved with the project since its inception, the product that is put on the child`s teeth is a topical fluoride varnish. Three fluoride varnish products are currently on the market. Dr. Bawden suggests that dental professionals carefully research the literature to determine amount and quantity of data documenting the safety and effectiveness of each product.

Not all of the products in their current formulation have been tested clinically. One of the products has been used successfully and safely for more than 25 years in Europe and Scandinavia as a caries preventative. The varnish has been approved by the Food and Drug Administration in the United States as a cavity prep liner and desensitizing agent. But it is being used "off label" (see related article), which means it is being used for a purpose not specified in the information provided with the product. The ADA has given one of the varnish products its seal of approval as a caries prevention agent, although this fact can`t be printed on the product label until the FDA approves it for caries prevention.

Dr. Bawden said, "There are about 109 published research papers and over 40 clinical trials with one of the varnishes, a real mountain of data. The product does at least as well as what we`re using if not better."

Under the pilot program, a thin layer of the varnish is applied to the newly erupted teeth of a high-risk, 9-month-old child who resides in this 11-county study area. A caramel-colored droplet of the varnish is applied to the child`s dry tooth. The varnish dries almost immediately. Dr. Bawden described the appearance of the treated teeth as "a bit dulled and yellowish" for the first few hours after a varnish application.

Compared to other topical fluoride products, he said the varnish is effective, quick, and easy to apply. He also said it was safe for children because little varnish, if any, is ingested during application, and patient acceptance is good. Dr. Bawden said the varnish has a "mild, salty taste." The parent is told to feed the child a soft diet for the rest of the day so the fluoride remains on the teeth as long as possible. The product is then easily brushed away by the parent the next morning.

He added that parents like the product because, unlike most fluoride treatments, they can actually see that something has been put on the child`s teeth. Under the study parameters, the child will receive an application of the fluoride varnish every six months until reaching the age of three.

Another unique feature to this program is that the fluoride is applied by medical personnel. Sailer said, "The application is quick and easy. Physicians and nurses are amazed at how easily they are becoming acclimated to the application process. During the planning phase, it became apparent that children at this young age were not accessing a dental office for care, but were regularly being seen in pediatric offices, family practice, and public health clinics. General dentistry is not geared toward providing care to such young patients, and in North Carolina there is a shortage of pediatric dentists."

The fact that medical personnel perform the preventive procedure apparently has not raised too many eyebrows in the dental community. "From the beginning, we sought dentistry`s support and expertise," Sailer said. "Dentists seem to be comfortable with trained medical personnel applying the varnish and educating the parent. Smart Smiles has been well accepted by dentists in the local program areas. Pediatricians are also very excited about the project."

Hygienists are involved since each program study area has a Smart Smiles dental hygienist who acts as a local program coordinator. The five hygienists who coordinate local studies are Jessica Norris, Lisa Swan, Melanie Durham, Pat Hedrick, and Diana Rothweiler.

"The hygienist`s role is to coordinate the delivery of services and train medical providers and community outreach/preschool dental education," Sailer said. He added that it was never intended that project hygienists be used as the provider of services, because Smart Smiles was intended to increase access to care for preschool-aged children. "Looking to dentists and hygienists as a sole provider source plays against the idea of creating access," said Sailer.

In North Carolina, the state dental practice act prohibits dental hygienists from working without the direct supervision of a dentist who must be on-site. So having hygienists apply the varnish was not feasible. The medical practice act in the state does not restrict a physician from performing dental care.

Sailer said they are hoping to see a quick payoff from the benefits of this program. "Smart Smiles is closely evaluating the program," he said. "The evaluation process has two main points: The effectiveness of fluoride varnish in the prevention of early childhood caries and an evaluation of the service delivery system." The implementation of care delivery is handled by each of six individual project locations. At the end of the study, treatment and service delivery methods will be compared. Sailer hopes that replicable models can be expanded statewide and nationally. Funding for the three-year Smart Smiles program is from the Appalachian Regional Commission.

Cathleen Terhune Alty, RDH, is a frequent contributor to RDH. She resides in Clarkston, Michigan, and can be contacted at [email protected].

Click here to enlarge image

A nine-month-old child receives an oral screening prior to the application of fluoride varnish. The screening is conducted by Pat Holland (left), a registered nurse with the Graham County Health Department in Robbinsville, N.C., while Pat Hedrick, RDH, (center) a project staff member watches.

Click here to enlarge image

The members of the Smart Smiles project hygienist staff are (from left): Melanie Durham, Pat Hedrick, Diana Rothweiler, Jessica Norris, Lisa Swan.

`Off label` drug use

Is it dangerous or libelous to use a fluoride varnish as a cavity preventive? Dr. James W. Bawden`s article in the Journal of Public Health Dentistry stated, "Because of the large body of published data documenting its effectiveness and safety, there is no legal risk in using fluoride varnish off label."

The varnish has been approved by Medicaid programs in at least two states and is used in pediatric dental departments around the country. He also writes that approximately half of all prescriptions issued in the United States during 1998 were written off label. When an off-label use becomes common, he writes, it becomes "the standard care in practice." He does caution dental professionals to research carefully the product literature to determine amount and quality of data documenting the safety and effectiveness of each varnish product.

For more information about fluoride varnishes, Dr. Bawden`s article was published in the Fall 1998 issue of the Journal of Public Health Dentistry. This article presents an overview, clinical application review, public health perspective, and effectiveness conclusions.

Clinical features of fluoride varnish are:

- Quick and easy to apply

- Good patient acceptance

- Can often be applied to teeth in difficult patients where a conventional gel can`t be accomplished

- Concentration of fluoride is twice as high as standard APF gel

- Comparatively small amount ingested during and after treatment

- At least as effective as four-minute APF gel

- Varnish remains on the teeth, especially in the pit and fissure areas and interproximal and cervical areas, releasing fluoride for a number of hours

- No intraoral suction or trays required with application

A dental Web site for parents

Dr. Fred Ferguson of East Setauket, N.Y., is on a quest. His mission? To fill in what he feels is a gaping hole in the life of parents with their newborn infant: simple and complete dental information.

"In my experience as a pediatric dentist, I know that common oral problems in children are totally preventable and predictable," Ferguson said. "Unfortunately, most parents receive no literature containing dental information early in their child`s life, or think of oral health before the birth of their child. By the time some children go in for their first visit to the dentist, there`s already trouble."

With this in mind, Dr. Ferguson launched About Smiles, Inc., and the Web site, The site contains a plethora of dental information for parents and all ages of children, from birth to adolescence. Topics range from thumb-sucking to teenage snacking to the use of mouthguards in sports. Separate age categories - birth to 3 years, 3 years to 6 years, 6 years to 12 years, and 12 years to adolescence - contain checklists to help parents know what to do about their children`s oral health and what trouble signs to look for.

"Most of the information on my Web site could be found in a textbook, but I want to give it to people in a way that they can understand and give them options for handling things such as a child`s pacifier or bottle," Dr. Ferguson said. "Taking care of your teeth begins at a very early age, and how a person`s teeth are treated as a child can affect him or her for the rest of his or her life."

Dr. Ferguson constantly updates the site and will soon have the site translated into Spanish as well as adding sections on oral health products, women`s oral health, and oral health for children with special needs, along with a review of common oral problems that adults can experience. He sees the Internet as the easiest way to teach people the importance of dental healthcare.

"The Web is not threatening for people. It`s in their home. I`m not standing over their shoulders telling them what is right and wrong," Ferguson said. "The entire site is in a question-and-answer style, and it`s going to continue to grow. People can understand any situation if it is put in a way that is user-friendly.

"I`m an educator (he is a professor of pediatric dentistry at the State University of New York at Stony Brook and associate professor in the department of pediatric medicine of University Hospital). I want to give people information so that they can prevent or gain control over their oral-health problems. I`m having fun helping people and seeing the site grow."

For more information, contact Dr. Ferguson at [email protected].