This invention concerns a xylitol candy, preferably a hard candy containing as sweetening agent mainly xylitol and being useful in treating and preventing carries. The candy can as sweetening agent contain merely xylitol or in addition other sweetening agents usually used in candy products, such as maltitol, lactitol, sorbitol etc.

The invention also concerns a kitt disclosing said xylitol containing candies, which kitt is suitable for the treatment and prevention of caries.

Xylitol has for long been widely studied whereby also the caries decreasing activity has clearly been demonstrated. These favourable results have been assumed in some extent to depend on the increased saliva secretion. This is the reason for that chewing gum has been a very popular xylitol product. Chewing gum has thus been tested in clinical long term tests and its favourable results have been determined.

The use of chewing gums is, however, not suitable for all occasions. Everyone does not want to chew chewing gum and consider its inconvenient, further chewing requires relatively effective chewing properties, etc.. In some locations and even countries the use of chewing gums is forbidden. There is there- fore a clear need to offer another type of xylitol containing product than chewing gum.

Surprisingly it has now been discovered that the same advantageous deterrent effect on the caries development is achieved by xylitol rich candies slowly dissolving in the mouth. Essential is that the candy do contain sufficient amount of xylitol so, that the amount of xylitol in the candies consumed per day corresponds to the effective amount of xylitol required to treat and prevent caries. The conducted clinical tests reveal that an advantageous daily dose is at least 3 g, preferably 3-10 g and most preferably 5 g per day.

This daily dose may preferably be divided into 4-10 candies per day.

The invention also concerns a kitt suitable for the treatment and prevention of caries, which kitt contains candies, pre- ferably hard candies, containing mainly xylitol as sweetening agent. Characteristic for this kitt is that the total xylitol content of the lozenge therein corresponds to the effective daily dose of xylitol.

Preferably the kitt according to this invention contains a daily lozenge dose containing at least 3 g of xylitol.

Preferably the daily dose is 3-10 g. More preferred is 5 g.

In the kitt the number of daily candies is 4-10. This daily dose may be arrange in one box or the box may be divided in several segments all containing the aforementioned daily dose.

To treat and prevent caries by sucking daily a certain number of xylitol candies would be a very effective way for replacing or supplementing the present widely spread xylitol chewing gum use.

In test studies the caries preventing effect of xylitol chewing gum and xylitol candies were measured under conditions where the products were given to pupils and the products were only used during school lessons on school days, whereby the control group basically did not use xylitol products. Another aim was to test the suitability of schools as a distribution system for xylitol.

A total of 12 schools participated in the test, and a majority of the pupils were born in 1984. Three schools were chosen for control groups, and were not given any additional prevention, two schools were chosen for the xylitol chewing gum group, three schools were chosen for xylitol lozenge group 1 and four schools were chosen for xylitol lozenge group 2. One of the lozenge was a common commercially sold"Plus"-throat lozenge (LEAF Oy) containing xylitol and maltitol. The other product was a preparation containing xylitol and polydextrose. The xylitol content of both lozenges was the same. The daily dose of xylitol in each group was about 5 g, which corresponds to six chewing gums 100 % sweetened with xylitol ("Xylifresh", LEAF Oy) or eight lozenges. Two pieces of chewing gum were

used upon arriving to school, two pieces at lunch time after eating and two immediately before the end of the school day.

Two lozenges were taken upon arriving to school, three after lunch and three immediately before end of the school day. The lozenges and chewing gums were given only on school days. The test lasted two-three school years.

The teeth of the children were controlled annually in September during the course of ten working days. Caries was registered on three various levels Dl, D2 and D3, where D1 means enamel caries, D2 a caries damage of the tooth requiring repair, and D3 so severe damage of the tooth that its treatment requires at least root treatment.

Results After two years of tests the teeth of a total of 629 pupils taken part from the beginning of the test were controlled in clinical inspections. The caries increment in each lozenge and chewing gum groups was practically the same. In classes were lozenge 1 had been used the D2MF caries increment for two years varied between 1,66-1,93, in lozenge 2 using classes between 0,89-2,4, in chewing gum groups 1,3-2,4 and in control groups 1,5-4,4. The caries increment for two years was generally the higher, the higher the initial level of caries accumulation was (Table 1). The total caries accumulation for two years on D2MF level was for one lozenge 1,71, and for the other 1,35, in chewing gum group 1,68 and in control group 3,22. All three xylitol groups differ from the control group statistically significantly (p<0,0001). The xylitol groups did not differ from each other statistically significantly. In comparison with the control groups about 50 % caries reduction was achieved in the test groups (Table 2).

The obtained result was a surprise. According to the present knowledge it would have been assumed that the chewing gum would have been more effective than the lozenge, and that the three month summer holiday would have degraded the results compared to earlier xylitol tests, but this was not the case. The sweet lozenge increased the stimulation of saliva as chewing gum does, but xylitol is assumed to stay longer in the mouth when

dosed in connection with chewing gums, and the retention time in the mouth has been assumed to be beneficial for the caries prevention. In this test xylitol was used only about two hundred days per year, so compared to a daily around-the-year use it was possible to save almost half the production costs without weakening the effect of prevention in comparison with earlier field tests.

Table 1 The average D2MFS index in 1994 and 1996 in 12 schools for children born in 1984 and caries increment in 1994-6.

Product N D2MFS-94 D2MFS-96 increment 1994-96 lozenge 1 29 4,51 6,44 1,93 "80 1,55 3,21 1,66 "86 2,03 3,73 1,70 lozenge 2 25 3,28 5,68 2,40 "35 2,09 2,97 0,89 50 1,20 2,32 1,12 39 1,03 2,43 1,41 chewing gum 88 1,23 2,53 1,31 "44 2,89 5,32 2,43 control 28 3,64 8,03 4,39 "52 0,85 2,33 1,48 73 2,56 6,59 4,03 total 629 Table 2 The total D2MFS index in 1994,1996 for the test and control groups and the caries increment per group. The caries increment for all xylitol groups; lozenge 1, lozenge 2 and chewing gum, between 1994 and 1996 did differ from the total increments of the control group statistically very significantly (***=p<0,0001, t-test). The increments of the xylitol groups did not differ from each other statistically significantly.

Product N D2MFS-94 D2MFS-96 increment lozenge 1 195 2,21 3,92 1,72*** lozenge 2 149 1,71 3,06 1,35*** chewing gum 132 1,78 3,46 1,68*** control 153 2,17 5,40 3,22