Dental Health International Nederland
Basic Package of Oral Care

Jo E. Frencken
Christopher J. Holmgren
Wim H. van Palenstein Helderman

WHO Collaborating Centre for Oral Health Care Planning and Future Scenarios

Chapter 3 - Affordable Fluoride Toothpaste (AFT) for the prevention of dental caries   

The use of fluoride toothpaste is considered to be the most efficient means of controlling dental caries. However, for it to be effective, the fluoride in the toothpaste needs to be bio-
available at a sufficient concentration at the tooth surface. This chapter discusses these aspects and ways in which governments and industry can ensure the availability of effective fluoride toothpaste at an affordable cost to consumers.

Fluoride for the control of caries
Exposure to the correct amount of fluoride is considered by the World Health Organization to be the most effective preventive measure against caries. Unfortunately, in most non-EME countries the recommended fluoridation of water and salt may not be easily attainable, since they lack the required infrastructure, technology and resources, particularly in rural areas. A report of an international workshop on fluoride states unequivocally that fluoride toothpaste is one of the most important delivery systems for fluoride. The caries-reducing effect of fluoride is almost exclusively topical, which explains the anti-caries efficacy of fluoride toothpaste.

Why fluoride toothpaste?

The anti-caries efficacy of fluoride toothpaste has been proven in an extensive series of well-documented clinical trials. These studies have involved different sources of fluoride (sodium fluoride, sodium monofluorophosphate, etc.), different levels of fluoride (mainly 1,000 and 1,500 ppm F _) and different abrasive systems (for example, silica, chalk, alumina, etc.).
     In many EME countries, there have been substantial reductions in dental caries over the past few decades. The number of teeth affected by caries (DMFT) decreased from about 8 to about 1.5 for 12-year-olds. Most scientists agree that the decline in dental caries in EME countries can be attributed mainly to the widespread use of fluoride toothpaste, particularly through twice-daily toothbrushing with fluoride toothpaste.
     Variations in the level of dental caries, both within and between non-EME countries, have been reported, so it is difficult to draw strong conclusions regarding the trend in dental caries in these countries. In areas with ongoing traditional lifestyles, the prevalence of dental caries may remain fairly stable. In some urban areas, the level of dental caries may increase. This assumption is based on changing dietary patterns and increased sugar consumption. In general, it can be concluded that there are contrasting trends in caries prevalence in children in EME compared to non-EME countries: EME countries have a decreasing trend while non-EME countries with improving economies show an increasing trend.
The interesting phenomenon in EME countries is that the incidence of caries has declined tremendously, although the total amount of sucrose consumption per capita has hardly changed. Where oral hygiene with fluoride toothpaste is adequate, diet has become a less significant factor in caries prevention. Hence, promotion of the exposure to fluoride through twice-daily toothbrushing with fluoride toothpaste is the first step in the prevention of caries. More than one billion people in EME countries use fluoride toothpaste for toothbrushing. This proven oral hygiene adjunct is the best cariesreducing measure. Therefore, widespread and
regular use of fluoride toothpaste in non-EME countries would have an enormous beneficial effect on the incidence of dental caries and periodontal disease. Nevertheless, in non-EME countries, widespread and regular use of fluoride toothpaste is uncommon. In addition to the benefits for preventing caries, toothbrushing has a favorable impact on the condition of periodontal tissues.

Developing an effective, low-cost fluoride toothpaste

The price of toothpaste is often too high in non-EME countries. Therefore many people cannot afford to use it regularly. Collaboration between the WHO Oral Health Program and industry resulted in the development of a new, low-cost fluoride toothpaste (SMFP), which proved to have anti-caries efficacy in a school-based oral health program in Indonesia.

Supervised daily toothbrushing with SMFP toothpaste (1,000 ppm F _) in a Chinese kindergarten, under conditions prevailing in a rural county in China and with minimal involvement of oral health personnel, also demonstrated the effectiveness of this preventive approach. After three years of study, a 43 percent reduction in caries was found among children who performed daily supervised toothbrushing with fluoride toothpaste and who received oral health education as compared to control children. In each of these studies, cooperation among dental academia, local government authorities and industry was the key to success.


Access and promotion

Promotion campaigns are required to attain widespread and regular use of fluoride toothpaste by people in non-EME countries. An important aspect in the outcome of such activities is the cost of the promoted toothpaste. All parties involved, i.e. governments, toothpaste manufacturers, the dental profession, and most important, the general population, would benefit if twice-daily toothbrushing with a pea-sized quantity of fluoride toothpaste were to become a widespread habit. Therefore, these parties should combine their efforts to reduce the price and to stimulate the use of fluoride toothpaste with anti-caries efficacy.

Toothpaste is often regarded by governments as a cosmetic product and is, therefore, subject to a higher level of taxation. This, in turn, makes toothpaste less affordable. Governments should recognize the enormous benefits of fluoride toothpaste to oral health and should take the responsibility to reduce or eliminate the tax burden on this product. Preferential tax consideration for toothpaste should be considered only when the toothpaste has been shown to have not simply appealing claims but proven anti-caries efficacy as well.
     The highest priority for toothpaste manufacturers should be to produce toothpaste with anti-caries efficacy, which people will buy and use. An affordable fluoride toothpaste that is "low cost" should not imply "low quality". Efficacy should be the highest priority. Fortunately, fluoride is a comparatively inexpensive ingredient. In contrast, such cosmetic components as flavor and packaging, which contribute to the intrinsic consumer appeal of toothpaste, are relatively expensive.                
Manufacturers are striving to produce lower-cost packaging for toothpaste. For example, sachets, rather than tubes, have been tried and have not detracted from consumer appeal. Moreover, producing paste in smaller containers lowers the unit cost to the consumer, which can also influence the decision to buy.

With economic growth, lifestyle changes often follow. People start to change their diets, pay more attention to their appearance and buy products, such as carbonated soft drinks, snacks and cosmetics, associated with these changes. However, it remains uncertain how people will decide which items get priority. The consumer may regard toothpaste primarily as a cosmetic that helps improve his or her looks and the way his or her mouth feels. Hence, the use of toothpaste may well fit into the new lifestyle. Advertisements for toothpaste should appeal to public sentiments of changing lifestyle and awareness of good oral health. This requires cooperation among government, toothpaste manufacturers and the health care profession in national advertisement campaigns. These campaigns should be combined with long-term reinforcement programs of oral health education, stressing the use of oral hygiene with fluoride toothpaste at an early age.

Using fluoride toothpaste effectively
Oral hygiene education should include advice on toothcleaning habits. Research has shown important links between the anti-caries efficacy of fluoride toothpaste and the way in which it is used. The two most important factors are brushing frequency and rinsing habits. Twice-daily brushing is recommended because it improves anti-caries efficacy compared to brushing once a day.                Thorough rinsing after brushing reduces the efficacy because it reduces fluoride in the mouth to sub-optimal concentrations. Therefore, no rinsing, or only once after brushing, is recommended.
      Education should also be targeted at the amount of toothpaste used. It is now recommended that only a "pea-sized" amount of toothpaste, about 0.5 g, be used. Toothpaste can be used with a toothbrush or chewing stick if that is the cultural norm. This small amount of fluoride toothpaste does not appear to reduce the effectiveness of the toothpaste. Besides, by using a smaller amount of toothpaste per brushing, the toothpaste will last longer, thereby making it more affordable. The main reason for recommending a pea-sized amount of toothpaste is the concern for young children who are less able to expectorate and who may ingest too much toothpaste, which might lead to dental fluorosis. To prevent dental fluorosis, it is also recommended that an adult supervise toothbrushing of children younger than six years of age. Clear instructions on the efficient use of the toothpaste, including the optimum amount of toothpaste to use, correct rinsing methods, and advice on supervising young children, should be printed on the toothpaste package.

Ensuring the efficacy of fluoride toothpaste
Recent analyses of toothpaste in several non-EME countries have shown that not all fluoride toothpaste on the market contains sufficient amounts of free ionized fluoride (NaF) or ionizable fluoride (SMFP). The efficacy of fluoride toothpaste depends on the amount of free ionized or ionizable fluoride.
     Most fluoride toothpastes, particularly private brands, are categorized as cosmetic products. They do not require approval from any regulatory body and therefore need not demonstrate proven anti-caries efficacy. Besides, many non-EME countries do not have adequate control mechanisms. Analyses are needed in non-EME countries to monitor locally available fluoride toothpastes for their anti-caries efficacy. The WHO Collaborating Centre in Nijmegen, the Netherlands, can act as an independent institute for monitoring the amount of free ionized or ionizable fluoride in locally produced toothpastes.
     The fluoride toothpastes on the market have varying concentrations of fluoride. The best choice might be toothpaste with between 1,000 and 1,500 ppm fluoride, since it seems that 1,000 ppm fluoride in toothpaste is more effective than lower concentrations of fluoride. A higher concentration of fluoride (>1,500 ppm F _) in toothpaste has the inherent risk of causing dental fluorosis when used by young children.


Recommendations

1.      Affordable fluoride toothpaste with anti-caries efficacy should be made available to all to ensure that all populations are exposed to adequate levels of fluoride by the most appropriate, cost-effective and equitable means.
2.     The packaging of the fluoride toothpastes should be clearly labeled with:
•     The fluoride concentration and the descriptive name of the fluoride compound;
•     Descriptive names of other ingredients, such as abrasives;
•     Production and expiration date;
•     Instructions for using a pea-sized amount of paste;
•     Directions for proper rinsing after brushing;
•     Advice for adult supervision of toothbrushing by young children.
3.      The method of dispersal of toothpaste should facilitate the use of small amounts of the paste.
4.     An independent laboratory should monitor the fluoride content of toothpaste.
5.      Fluoride toothpaste that meets recommended standards for efficacy should be tax-free and classified by governments as a therapeutic agent rather than a cosmetic.