Australian Dental Journal, April, 1967 105

Observations on the cariostatic effect of calcium sucrose phosphate in a group of children aged 5-1

years *

Preliminary report

Robert Harris,+ Rezso G. Schamschula,tt Geoffrey Gregory,ttt Miriam Roots,$ and John Beveridge$$

Introduction Much evidence has been accumulating during

the past decade which indicates that phos- phates may bring about significant reduction i n the development of carious lesions when they are added to the diet of rats.

It is well known that dietary changes may have marked effect on the incidence of caries in such animals as rats and hamsters. Never- theless, it is unwise to infer that results so obtained will be produced in human caries. The effect of total mineral deprivation on rats' teeth is variable and Jenkins") does not place much value on these experiments, because the deprivation greatly reduces appetite and therefore the intake of all nutrients. However, Clarke and Smith(2) showed that the ash content of incisors fell by a smaller amount than occurred in the ash of bone. Gaunt and Irving(*) studied the effects of variation in the Ca/P ratio and i n

* Lecture presented at the 18th Australian Dental Congress, Melbourne, February-March, 1967.

The financial support of the Colonial Sugar Refining Company Ltd. in the conduct of this clinical trial is gratefully acknowledged.

t Director, Institute of Dental Research, Sydney. t t Formerly Senior Research Officer Institute

of Dental Research, Sydney ; now Princihal, Dental Training College, Papua-New Guinea.

t t t Reader, Department of Statistics, University of Melbourne.

$ Dietitian, part-time, United Dental Hospital, Sydney.

$$Professor of Pediatrics and Head of the School of Pediatrics, University of New South Wales.

Jenkins, G. Neil-The physiology of the mouth. Oxford, Blackwell Scientific Publications, 1966 (P. 224).

t2)Clarke. Miriam F.. and Smith. A. H.-Deflcient saline diet and development' of teeth. Am. J. Physiol.. 112: 2, 286-293 (June) 1935.

(*)Gaunt. W. E.. and Irvinx, J. T.-The influence of dietary calcium and phosphorus uuon tooth formation. J. Physiol., 99 : 1, 18-29 (Dec.) 1940.

7

the percentage of calcium and phosphorus on the weight, composition and histological structure of bones and teeth. They concluded that teeth were much less affected than bones and were not affected at all, if the diet con- tained more than 0.4 per cent of calcium and phosphorus, and further that the bones were more sensitive to a high than to a low Ca/P ratio; whereas in the groups with a low per- centage of calcium and phosphorus the teeth were only affected by a low Ca/P ratio.

The histological changes were increased width of predentine, interglobular spaces and vascular inclusions but no direct relevance to the caries resistance of the teeth was found.

There appears to be some relation to caries resistance in the effect of the Ca/P ratio on the composition of the teeth. For where the ratio is high, enamel formed has a high carbonate content and is more liable to caries than the enamel of control animals,(4' although McClure and McCann(B did not And this effect. Many writers have referred to the lower caries prevalence in peoples living on diets devoid of refined carbohydrates. Osborn(6) found that the South African Bantu living in towns and consuming westernized foods had higher caries incidence than those living in their native kraals. He suggested that refinement removed

(') Sobel A. E.. Shaw, J. H Hanok A and Nobel S.-Calcification. XXVI. Carids &sceDtibiliti in relation to composition of teeth and diet. J. D. Res., 39 : 3. 462-472 (May-June) 1960.

(5) McClure, F. J., and McCann, H. G.-Dental caries and combosition of bones and teeth of white rats: effect of dietary mineral supple- ments. Arch. Oral Biol., 2: 2, 151-161 (July) 1960.

Osborn. T. W. G.. and Noriskin. J. N.-The relation between diet and caries ' in the Soith African Bantu. J. D. Res., 16: 5, 431-441 ( O r t ) 1937.

I06 Australian Dental Journal, April, I967

some protective factors and thought that this may be some form of phosphate.

Ericsson(') in a review indicated that phos- phates, mainly calcium, constitute the bulk of substances lost from the dental tissues in caries. An acid dissolution process is over- whelmingly probable, and phosphate ions are known both to play a part in the carbohydrate degradation leading to decalciflcation beneath the plaque and to exert a buffering effect in the pH range around neutrality. On the other hand, an uptake of calcium and phosphate ions by the tooth surface is well established, and this seems to have a reparative effect in incipient caries in some instances, also a solubility reducing action.

Several different lines have been followed in research on the role of phosphates and extensive experiments with different phosphate additives in the diet of animals have yielded differing results.

Klein and McCollum@) reported an increase of dental caries in rats with a decrease in phosphorus content of the diet but later thought this might be due to the particle size of the constituent^.(^) Blackberg and Berke,(I0) Agnew, Agnew and Tisdall,(") Rosebury and KarshancLI) have all noted reductions in dental caries experience when phosphates were added to the diet of rats or hamsters.

In some instances the results have been enhanced when sodium chloride has been added simultaneously and, where fluoride has been added, the results have been found to be independent and additive.(ls

The phosphates used have included the ortho- phosphates, metaphosphates, pyrophosphates, tri-

(7 ) Ericsson, Y.-Phosphates in relation to caries. Internat. D. J., 1 6 : 3, 311-317 (Sept.) 1965.

(a)Klein, H.. and McCollum. E. V. A.-A ure- liminary- note on the significance of the phos- phorus intake in the diet and blood phosphorus concentration in the exoerimental uroduction of caries immunity and caries su&eptibility in the rat. Science, 74: 662 (Dec.) 1931.

@)Klein, H., and McCollum. E. V. A.-The sia- niflcance of food particle size in the etiology in microscopic dental decay in rats. J. D. Res., 13: 1, 69-71 (Feb.) 1933.

(10) Blackberg. S. N.. and Berke. J. D.-Dental caries experimentally produced in the rat. J. D. Res., 12: 4, 609-627 (Aug.) 1932.

(n)Agnew, Mary C., Agnew, R. S., and Tisdall F. F.-The production and prevention of dentai caries. Am. D. A. J., 20: 2, 193-212 (Feb.) 1 S R R

(18 Rik&ry, T., and Karshan, M.-Susceptibility to dental caries in the rat. V. The influence of calcium, phosphorus, vitamin D and corn oil. Arch. Path., 20: 5. 697-707 (Nov.) 1935.

(=)Barnard, P.. and Johansen E.-Effect of CaHPO, and N a F dietary ' supplements on experimental caries. J. D. Res. (Abs.), 37: 1, 82 (Feb.) 1968.

phosphates and the organic compounds disodium glycerophosphate, sodium and calcium phytate, fructose diphosphate, calcium sucrose phos- phate. Feodorov,'") in a study on rats, observed that calcium glycerophosphate as a food addi- tive a t the rate of 0.025 gm. per rat daily had twice the caries preventive effect of sodium fluoride in the drinking water at 1.0 mg. per litre. Later studies,(') where the calcium glycerophosphate was incorporated in a denti- frice (calcium glycerophosphate 2.6, carboxy- methylcellulose 2.0, chalk 29.6, salt 2.9, glycerine 20.0 and water 43.0) showed a caries reduction of approximately 48 per cent, where- as the caries reduction with sodium fluoride paste was only 16 per cent. Stookey and Muhler("') have reported results on the use of sodium dihydrogen phosphate (NaH,PO,) used as an additive in presweetened cereals in the diet of rats which showed an increase in the total amount of phosphorus of 0.08 per cent. The additive nullified the effect of the sweetening agent in the phosphate enriched cornflake diet; it was further noted that the additive also reduced the amount of caries, even when added to non-sweetened cereals in the cariogenic diets. Incidentally, higher caries rates were noted in the rats eating corn and rice cereals compared with the wheat and oat breakfast cereals.

More recently Lilienthal and his co-workers") studied the effect of calcium sucrose phosphate on the caries prevalence in rats. They noted variable results not only with that phosphate but with others and there was a variation as between phosphates. The phosphorus content of the calcium sucrose phosphate added at 1 per cent was equivalent to the phosphorus content supplied by 0.3 per cent dicalcium phosphate. While calcium sucrose phosphate at this level caused a marked reduction in caries activity, the dicalcium phosphate did

(14) Fedorov, Y. A.-The effect of phosphorus, calcium and fluorine compounds on experi- mental dental caries in white rats. Doklady Akad. Nauk. U.S.S.R., 137: 6, 1481-1484, 1961 (trans..)

(m)Fedorov, Y. A.-The study of localized action of calcium glycerophosphate and sodium fluoride on dental caries in experimental white rats. Doklady Akad. Nauk. U.S.S.R., 161: 1, 244-247, 1965 (trans.).

(Ie) Stookey, G. H., and Muhler, J. C.-Anticario- genic effect in the rat of cereals fortifled with soluble phosphate. J. D. Res., 45: 3, 866-864 ( May-June) 19 6 6.

(IT) Ltlienthal, B., Buah, Elizabeth, Buckmaster, M., Gregory, G., Gagolski J., Smythe B M Curtin, J. H., and Nap'per, D. H.-The carid: static effect of carbohydrate phosphates in the diet. Austral. D. J., 11: 6, 388-396 (Dec.) 1966.

Australian Dental Journal, April, 1967

not produce a significant reduction until present at a level of 1.0 per cent. Further- more, where 10 p.p.m. sodium fluoride was added to the drinking water, further reduction in the caries activity was noted.

A difference in caries reduction was also noted depending upon the manner in which the calcium sucrose phosphate was in- corporated in the different diets. For example, bread baked with 2 per cent of the phosphate showed a significant reduction in caries. The admixture of powdered crackers and the phos- phate was not as efficacious as when calcium sucrose phosphate was intimately mixed with the cracker before baking.

McClure(ls)(lg) has studied the effect of phos- phate additive on rodent caries and also when it was administered by intubation(")(") and it appeared fairly clear that the effect was localized in the oral cavity. McClure(a) sug- gested, on the results of unpublished data, that a sugar phosphate might well be useful as an additive in the study of the effects of phosphates on caries in man.

Dawes and Shaw(=) found no differences in serum and salivary calcium and inorganic phosphate analyses among three groups of rats, two of which had lower caries prevalence and postulated that the effect must have arisen from local action on the tooth surface.

Napper and Smythe(=) and Brady, Napper and Smythe'") have shown that the action of calcium sucrose phosphate was not to decrease the solubility of hydroxyapatite, in the manner of fluoride ions, but to inhibit the rate of dis- solution of hydroxyapatite by adsorption at kink sites on the hydroxyapatite crystal surfaces.

I07

(18) McClure, F. J.-Further studies on the cario- static effect of organic and inorganic phos- phates. J. D. Res., 42: 2, 693-699 (Mar.-Apr.) 1963.

(19) McClure, F. J.-Cariostatic effect of phosphates. Science, 144: 1337-1338 (June 12) 1964.

("0) McClure, F. J., and Muller, A., Jr.-Further observations on the cariostatic effect of phos- phates. J. D. Res., 38: 4 , 776-781 (July-Aug.) 1959.

(fl) McClure, F. J.-Cariostatic effect of dietary vs. intubated phosphate. Arch. Oral Biol., 1 0 : 6, 1011-1013 (Nov.-Dec.) 1965.

(B) Dawes, C., and Shaw. J. H.-Dietary phosphate supplementation and its effect on dental caries and nalivarv serum concentrations of calcium - and inorpakc phosphorus in the rat. Arch. Oral Biol., 10: 4 , 567-577 (July-Aug.) 1965.

(")Napper, D. H.. and Smythe, B. M.-The dis- solution kinetics of hydroxyapatite in the presence of kink poisons. J. D. Res. (in press).

(~4 ) Brady. B. H. G., Napper, D. H., and Smythe, B. M.-The dissolution kinetics of hydroxy- matite. Nature, 212: 5057, 77-78 (Oct. 1) 1966.

C

The results of animal studies suggested that caries preventive action using the same principles could be achieved in humans. A number of studies have been reported (StrB1- fors,(=) Ship and Mickelsen,("), Bibby,(n' and Averil, Friere and Bibby,(=) in which a phos- phate has been used as a food additive. Recognizing that there are many difficulties in the setting up and carrying through of a clinical trial on humans, these results are equivocal. In the case of StrBlfors, fluoride was found to be present in the phosphate used during the first year of the study at. 250 p.p.m. and the source of phosphate was changed (20-25 p.p.m. fluorine) for the second year. His estimate of the effect on caries was judged by radiographic examination of the upper central teeth. Ship and Mickelsen found, after three years, no difference in caries activity in children who had consumed bread which contained 2 per cent CaHPO, and a control group. Averill and Bibby, in a two-year study, added 2 per cent dicalcium phosphate to the flour and sugar used in the preparation of bread, pastries, desserts and table sugar eaten by children, aged 8-12 years, and found no difference i n caries activity between test and control. Averill, Friere and Bibby found in Brazilian children, 6-13 years of age, no significant difference between the test and control groups of those surfaces present and non-carious at commencement of the study, where dicalcium phosphate was used as a food additive. There was a significant difference in the caries activity of those surfaces erupted during the study, when the second molars and premolars were selected for examination.

The reason for the marked difference between results achieved in the use of phosphates as cariostatic agents in rodents' teeth and in studies on humans is not certain, although there is a lesser phosphate content in rats' saliva and there are other differences such as the degree of cariogenicity of the diet, the caries susceptibility of the animal strain, the

(5) Str%lfors, A.-The effect of calcium phosphate on dental caries in school children. J. D. Res., 4 3 : Suppl. 6, 1137-1143 (Nov.-Dec.) 1964.

(a) Ship, I. I., and Mickelsen, 0.-The effects of calcium acid phosphate on dental caries in children : a controlled clinical trial. J. D. Res., 4 3 : SUPPI. 6, 1144-1149 (Nov.-Dec.) 1964.

w) Averill. H. M., and Bibby. B. G.-A clinical test of additions of phosphate to the diet of chll- dren. J. D. Res., 43: Suppl. 6, 1150-1155 (Nov-Dec.) 1964.

(28) Averill H. M., Friere, P. S., and Bibby B. G.- The effect of dietary phosphate suiplements on dental caries incidence in tropical Brazil. Arch. Oral Biol.. 11: 3, 315-322 (Mar.) 1966.

108 Australian Dental Journal, April, 1967

pure bred beagles and rats. The animals were fed on diets containing 2, 5, and 10 per cent calcium sucrose phosphate over a period of two years. No abnormalities were found in growth, general health, in the blood or in the urine and in organs at post mortern.(=)

The acceptable daily intake of phosphates for man has been set out in World Health Organization Technical Report No. 281, 1964, and for calcium in W.H.O. Technical Report No. 230, 1962. For communities with low calcium intake, the intake for phosphates is 30 mg./kg. body weight as a total dietary phosphate; where the calcium intake is high, the phosphate intake may be raised to 70 mg./kg. body weight. Since 2-3 gm. of calcium per day can be taken without detrimental effect (W.H.O. Technical Report No. 230, 1962) and there is no evidence that a daily intake as high as 1300 mg. calcium per day is un- desirable, the average weight of carbohydrate available per head per day is 420 grams (Food and Nutrition, Notes and Reviews, Australia, 1964) to which is added 1 per cent of calcium sucrose phosphate (7.5 mg. calcium/kg. body weight and 6.7 mg. phosphorus/kg. body weight) leads t o calcium and phosphorus levels which are well within acceptable limits.

On the basis of the animal studies on caries the laboratory investigation on the inhibition of subsurface decalcification of enamel, the small but significant reduction in incidence of dental caries when calcium sucrose phos- phate was incorporated in a dentifrice, the toxicity tests, the dietary allowances as set down by the World Health Organization and other authorities, it was considered that suf- ficient information was available to proceed with a clinical trial of the efficacy of calcium sucrose phosphate as a cariostatic agent in the diet of humans.

oral microflora, the length of the feeding period, the care and housing of the animals, the stage of maturation of the enamel when the teeth a re exposed to the diet.

Nevertheless, some results(=) obtained from the use of a dentifrice in which calcium sucrose phosphate was incorporated showed a small but significant reduction in dental caries in certain teeth.

Calcium sucrose phosphates are among the many sugar phosphates known to occur widely in natural products. Some have been isolated and also prepared synthetically. Calcium sucrose phosphates were first prepared in 1910 by Neuberg and Pollak by the reaction of phosphorus oxychloride on an aqueous solution of sucrose in the presence of excess calcium oxide. This gave a mixture of various sucrose phosphates, the nature and proportions of which are, however, constant and approximate to the formula of the mono-orthophosphate ester of sucrose-C,,H,,O,,PCa2H,O.

Sucrose phosphoric acid ester was manu- factured in Germany and the calcium salt marketed under the name Calcium Hesperonal and used as a substitute for glycerophosphate which had become expensive during wartime. The Colonial Sugar Reflning Company Ltd. has produced a substance which is a mixture of the same calcium sucrose phosphates as those produced by Neuberg and Pollak but it contains different proportions of the sucrose phosphates and more inorganic calcium phos- phate, The calcium sucrose phosphate is a flne, white powder, which is not hygroscopic but is readily soluble in water in all pro- portions. In vitro studies have shown that the subsurface decalciflcation of enamel, recognized as an early stage in the initial carious lesion, can be inhibited by the addi- tion to the system of calcium sucrose phosphate in amounts as low as 0.6 per cent.

Toxicity studies in rats by Li l ienthaP) have shown that calcium sucrose phosphate mixed with food at a level of 10 per cent for a period of three months showed no ab- normalities in growth, hematological data, urine analysis and all animals appeared healthy when sacriflced and no pathological changes were found post mortem.

Long-term toxicity studies were undertaken by Hazelton Laboratories Inc., Virginia, using

(9) Lilienthal B.-Private communication 1965. me) Lilienthal: B.-Personal communicatioh, 1963.

Material and methods In order to implement such a trial the

cooperation of a number of charitable and religious organizations was sought and their permission obtained to participate in the study. Certain factors limited the availability of some institutions and their wishes to participate of necessity had to be declined because of the rapid transfer of children through their respective institutions. The location of the Homes in relation to a central

Paynter, 0. E.-Private communications, 1964, 1965, 1966.

Australian Dental Journal, April, I967

Control Treatment

102 40 209 171 321 197

109

Totals

142 380 518

point of distribution of foods was a minor but important feature and the proximity of Homes to the metropolitan Sydney area ensured a uniformity of geographic and climatic elements. By contrast a small group of four Homes was located in a city in the Southern Tablelands of New South Wales where fluoridation has been in operation since 1961.

Before the administration of the calcium sucrose phosphate was commenced, a survey was undertaken of the dietary regime in each Home. One Home waa excluded from the study because daily fluoride medication had been introduced.

TABLE 1 Children, aged 5-17 years, examined after m e year in

Age group

5- 8 .. 9-12 . .

13-17 .. Totals 632 I 408 I 1040

Prior to the implementation of the pro- gramme honorary medical and dental ofacers of the various institutions were consulted and their cooperation sought. Every endeavour was made to ensure that the pattern of dental treatment remained unaltered and no attempt was made to improve methods of oral hygiene as practised by the children.

Two groups of subjects were selected, one to receive the treated food and the other to be used as a control. In order to have a suitable and valid result a n estimate of the size of the groups, based upon the data pre- sented in Barnard's survey,'") showed that approximately 400 children in each group were required.

The study was commenced in February- April, 1965, with children who lived i n 19 Homes and followed the same pattern of life so that they spent approximately the same amount of time in the Homes each year. Nine Homes cared for boys, seven for girls and

(32) Barnard, P. D.-Dental survey of State school children in New South Wales, Jan. 1954- June, 1955, N.H.M.R.C. Sp. Rpt. Series No. 8, Canberra, 1956.

three for both boys and girls. Eight institu- tions were allocated to the treatment group and eleven to the control group, which included three Homes caring for both boys and girls. In a trial of this type it is impracticable to have treatment and control subjects within one institution because of the necessity for strictly controlling the test diets.

Approximately equal numbers of children, aged 5-17 years, were originally in the treat- ment (619) and the control (608) groups. However, the initial examination revealed that there was an imbalance between the numbers in the age-groups of boys in the two groups with more boys over the age of 12 years in the test group. The records of the institutions showed that a n inevitable loss of children occurred and in order to correct this im- balance, which would be aggravated as the study proceeded, 292 boys, aged 12-16 years, were added to the control group in September, 1965. Table 1 shows the numbers remaining for the second examination. It was recognized that the majority of children over 12 years of age in the control group had an average of seven months between the first and second examinations compared with twelve months for the others. However, this disadvantage was considered to be outweighed by the avail- ability of sufficient control children of appro- priate age for the later years of study. I t should be emphasized, however, that all chil- dren present in the Homes at each annual examination will be included and, as the study will extend over a period of more than three years, i t will be possible to have a reasonable number of children in each of the age-groups participating for a t least two years.

The examination for dental caries was divided into two parts: (i) the clinical examination of all cleaned and dried surfaces of the teeth was made with a mirror and probe with standard tungsten filament illumin- ation: ( i i ) the proximal surfaces of the posterior teeth were examined by means of standard interproximal X-ray examination. The radiographic data were examined by standard illumination and assessed by two examiners.

All observations were recorded by a n assistant on the one form which hae provision for the relevant data for the identiffcation of the child, frequency of toothbrushing, the institution and the dental caries status.

I10 Australian Dental Journal, April, I967

The observer made his examination and announced his assessment of the carious lesion according to the numerical system for each of the tooth surfaces:

0 Unerupted tooth: no par t of crown visible. 1 No evidence of dental caries, past or

2 Initial caries: present.

A. Pits and fissures: there is a defifiite resistance to the withdrawal of the specified explorer and there is no hard sound tooth enamel felt at the depth of the pit or fissure.

B. Smooth surfaces: there is obvious de- calcification of the enamel but the lesion is wholly within the enamel.

C. Proximal lesions, anterior teeth: the lesion is wholly within the enamel as seen by reflected light or as felt by the probe.

D. Proximal lesions, posterior teeth: the assessment is made from radiographic examination.

3 Early caries: A. Pits and fissures: there is no obvious

open cavitation but the depth of the lesion is such that the whole point of the probe disappears within the tooth.

B. Smooth surfaces: the depth of the lesion has reached the dentino-enamel junction.

C. Proximal lesions, anterior teeth: the dentino-enamel junction as seen by reflected light or as felt by the probe.

D. Proximal lesions, posterior teeth: the assessment is made from radiographic examination.

4 Obvious open cavitation due to caries in- volving the dentine or dentine and pulp, all zinc oxide temporary dressings and obvious recurrent caries. Posterior teeth only: any lesion involving more than one surface is classified separately with respect to all surfaces involved. It is unlikely. however, that a lesion normally classified as 2 or 3 would involve more than one surface.

6 Surfaces with a restoration.

8 Surfaces which cannot be satisfactorily examined by direct observation or radio- graphic means.

Standardization of methods: ( i ) A plane mirror with standard probe,

point 1.5-2.0 mm. in length and standard taper, was used. All probes were measured

wire eauge and were replaced after ten full-mouth clinical examinations.

( i i ) A Planet 12 volt lamp was used u 1 1 1 ~

source of standard illumination. (iii) Calibration of examiners was carried

out before the trial commenced and repeated prior to subsequent examinations.

( iv) The dental examinations were made by the same examiner throughout the trial and a reserve examiner has been recruited. Both examiners have been trained with the super- vising examiner.

(v) Repeat examinations: wherever pos- sible and subject to cooperation of the school teachers (since examinations are conducted during school hours) replicate examinations are made of 10 per cent of the children at each Home or Institution and the observations used as a check on the consistency of the examination. I n addition independent examin- ations on a number of children a re made by the supervising examiner and a recorder using identical facilities. The results of these independent examinations are assessed and discussed.

(vi) A tape recording of all observations is made and used for checking where doubt may have existed during the writing down of the examiner’s assessments.

I t was decided the criterion of effectiveness of the additive should be the change in the mean number of DMF teeth per child or the change in the mean number of DMF surfaces per child at the second and subsequent examinations. Since the analysis of data was to be performed by computer, the more refined DMF surface change per subject was used.

Prior to commencement of the trial a dietary survey was made covering the daily food intake and the eating practices i n all institutions. The average consumption of processed carbohydrate foods, based on this

6 Tooth extracted or accidentally lost: a pilot study, is shown in Table 2. In general note is made if extraction for orthodontic the consumption of carbohydrate foods in purposes can be determined. these institutions was higher than that found

in a survey undertaken some years ago at a face occurdng independently from the Sydney boarding school.(a*) existing restoration.

7 New lesions on a previously restored sur-

Loh, P.-Private communication,

Australian Dental Journal, April, I967 I l l

Ib. carbo- hydrate/ child/ day

0.167 0.033 0.041 0.008

0.018 0.039

0.040 0.028 0.030 0.372 0.078

0.864

Dietary supervision is to be maintained TABLE 2 throughout the trial by regular visits of a Carbohydrate intake of children i n the trial

Per- centage of total carbo-

hydrate (0.854

lb.) ______

19.5 3 . 9 4 . 8 0 . 9

2 .1 4 . 6

4 .7 3 . 3 3 .5

43.5 9 . 1

_ _ ~

dietitian whose task is to ensure that the intake of food remains approximately the same in calories and in general composition during the trial as before it commenced. At each visit the dietitian makes observations on: (i) the amount of food received into each Home during the current week; (ii) the amount of waste in preparation of the food; (iii) the amount of food left over at the end of the meals; (iv) the actual serving of the indi- vidual meals throughout a day. Supervision of the invoices for foods before and during the trial and of the storeroom in which the food is kept is to be under the general sur- veillance of the dietitian.

The addition of calcium sucrose phosphate to these foods? was made as shown in Table 3.

The estimated average intake per child of 4.3 gm. of calcium sucrose phosphate would mean about 500 mg. of calcium per day: an increase of about 50 per cent on the existing

Sugar, white Sugar, brown Flour, S.R. Flour, plain Golden syrup and/or Honey . . Jam .. Weetbix and/or Cornflakes Oatmeal . . Tinned fruit Bread . . Biscuits . . _ -

Total

calcium intake of children in these institu- tions. At intervals throughout the trial dietary surveys are being made to ensure that the dietary pattern remains unchanged and samples of the food obtained from each insti- tution a t weekly intervals are tested for the presence and amount of the additive. More information on the calcium absorption and excretion will be given by Professor Beveridge, who will report on the medical survey.‘”)

Sugar, white . . Sugar, brown . . Flour, S.R. .. Flour, plain . . Golden syrup and/or

Honey . . .. Jam . . Weetbix and/or

Cornflakes .. Oatmeal . . .. Tinned fruit . . Bread . . . . Biscuits . . ..

Results The observations made in 1965 and 1966

have been recorded and analysed to demons- trate any differences which may exist in the dental caries experience of the treatment and the control groups. The reduction in numbers of children seen at the examination held at the end of the flrst year is indicative of the problems encountered in this type of study.

In all 1,040 children were present at the flrst and second examinations and their results have been grouped into three classes in the ages 5-8, 9-12 and 13-17 years. Table 4 shows the DMF surfaces for boys and girls in both control and treatment groups in 1965 and the mean number of new carious surfaces in 1966.

1.0 1.0 1.0 1.0

1.0 1 .0

O* O* 0 . 2 t 0 .63 1 . 0

t The compounding and supply of these foods to the Homes in the test grouD was under the control of the Colonial Sugar Reflning Company Ltd. (G Manuscript in preparation.

Average 1 con-

Food tion Ib./

child/ day

0.167 0.033 0.054 0.011

0.024 0.054

0.053 0.040 0.149 0.776 0.103

1.464

Per- centage carbo-

hydrate

100 100

76 76

76 72

75 70 20* 48 76

I

* Of this 20% carbohydrate about 11% or 12% comes from added sugar.

TABLE 3 Levels of addition of calcium sucrose phosphate

Food

Percentage CaSP added on finished weight of

food

lb. CaSP/ ohild/day

0.00167 0.00033 0.00054 0.00011

0.00024 0 * 00064

0 0 0*00030 0.00468 0.00103

Total . . I . . I 0.00942

* Not treated, as normal use of treated sugar or syrups should result in the addition of approximately 0.3% CaSP to total carbohydrate.

t 1% on total carbohydrates. 2 1% on flour. 0.00942 Ib. = 4 . 3 g. CaSP/child/day.

I12

No. child.

122 33

155

237 84

321

355 67

422

898

Australian Dental Journal, April, I967

Discussion In a trial of this nature it is essential to

have sumcient chidren in both test and control groups to yield data capable of valid inter- pretation. Furthermore, because of the nature of dental caries and its variable spread of attack on individual teeth and its variability as between individuals, it is also essential to extend to a minimum of three years the course of a clinical trial designed to measure a cario- static effect. The Commission on Oral and

~~

Mean DMFS

3 . 1 3 2 . 9 7

3 . 0 9

11 .23 13 .27

11 .76

2 9 . 7 9 36.97

30.92

19 .27

_ _ _ ~

_ _ _ ~

~~

_ _ _ ~

-___

____-_

~~

It will be noted that at the begipning of the trial the children in the treatment groups (619) had an average caries prevalence measured in DMF surfaces (20.43) higher than that of the children in the control group (19-27). In the oldest group this relationship was reversed (29.11; 30.92). The increase in caries attack has been expressed in Table 4 as the mean number of new DMF surfaces observed a t the 1966 examination for the chil- dren also present a t the 1965 examination.

No. child.

80 22

TABLE 4 DMF aurfaceafor boya and girla in control and treatment groups in 1965 and the mean number of NEW c a r d

auqfacea in 1966

Mean new

DMFS ___-

4 . 3 5 3 . 0 9

Control Group

NO. child.

16 24

Treatment Group

Mean new

DMFS __-___

2 . 1 9 2 . 4 2

-_-____ 1966

40

117 54

2 . 3 3

4.65 5 . 0 6

_____ 159 50

209

280 41

321

632

5 . 9 7 7 . 5 8

6 . 3 5

7 . 2 4 9 . 5 1

7 . 5 2

6 . 5 6

___-

~ _ _ _

~ _ _ _

___-

149 68

217

12.65 8 . 5 6

11 .32 ~~

171

158 39

197

4 . 7 1

6 . 4 6 7 . 7 9

6 . 7 2

~ _ _ _

_ _ _ ~

276 66

342

28 .92 30 .24

29 .11 _____

1965 1966 Sex

No. I >I?an child. DMFS --_ I-

5-8 Male . . Female . .

Total . . 102 I 4 . 0 7 60 I 3 . 2 3

Male .. Female . . 9-12

Total . . Male . . Female . . 13-17

Total . . 619 I 2 0 . 4 3 408 I 5 . 4 7 All children

It will be noted that the difference in favour of the treatment group is greatest in children aged 5-12 years. The difference is significant for the population as a whole; when considered by ages, the differences are significant for the two younger groups of children but not for the older groups.

Dental Statistics of the FBd6ration Dentaire Internationale has recommended preferably a five-year programme for such studies. Where such organizational problems as the produc- tion, distribution and consumption of foods containing the agent have to be solved in relation to children living in a number of different institutions, the difficulties of con- tinuing the trial for five years and maintain- ing the standard of control in subjects and personnel severely limit the application of the FBdBration Dentaire Internationale recom- mendation. The results reported herein there- fore must be viewed as only a progress report

It is to be noted that the incidence of dental caries in the control group, expressed as DMF surfaces per child a t each age-group from 5-17 years determined on the 1966 observations, is somewhat higher than that seen in the 1965 results.

Australian Dental Journal, April, 1967 I I3

and an indication that calcium sucrose phos- phate as a food additive, as used in this study, has reduced the amount of dental caries by a significant amount (1-97 surfaces per subject i n the age-group 9-12 years, 1.42 surfaces per subject in the age-group 5-8 years). The older children (13-17 years) showed a similar reduction (1.25 surfaces per subject) but this was not significant.* In assessing these latter results it is to be emphasized that in the age groups 13-17 years of the 422 children origin- ally i n the control group, 255 boys were from a boarding school whose first dental examina- tions were made five months after that for the other children. It is therefore reasonable to accept the interpretation that the caries increase for that group over a twelve-month period might be greater. This may account for the reduced difference between the treat- ment and control groups at the higher age level. This point should be clarified in sub- sequent examinations.

The control of food intake cannot be totally implemented, since the children in many cases attend schools away from their institutions. However, frequent and regular inspections of the kitchens, food provisioning and the pur- chasing systems were made and ensured a minimum variation from the original pattern.

The medical observers found no differences in the values recorded in their several studies between the test and control groups.

*These figures are calculated on the mean differences in new D M F surfaces for boys and girls.

Summary 1. A first progress report on the value as

a cariostatic agent of the addition of calcium sucrose phosphates to carbohydrate foods in the diet at the average rate of 4.3 gm. per day for each of 408 children, aged 5-17 years, demonstrates 8 beneficial effect. 2. The result has been compared with the

caries increase i n a control group of 632 chil- dren, aged 5-17 years.

3. The average reduction in dental caries per child 6-8 years of age is 1.42 surfaces, 9-12 years of age is 1.97 surfaces and 13-17 years of age is 1.25 surfaces. 4. The reduction is consistent for the popula-

tion as a whole. 5. Considered by ages the reduction is

significant for children aged 5-12 years of age.

Acknowledgement

This study could not have been contemplated nor carried out without the assistance of many ancillary staff from the Institute of Dental Research and the Colonial Sugar Refining Company Ltd. whose ser- vices are gratefully acknowledged. T w o should, however, receive special mention : Miss Wendy Silver, dental nurse and secretary, and Mr. F. L. Higgs, X-ray technician, whose cooperation enabled the major portion of the radiographic work to be completed after normal working hours.

The Institute of Dental Research, United Dental Hospital, 2 Chalmers Street,

Sydney.

Marx, poor man, is still required by his disciples to have had the supernatural power of seeing everything for all t i m e . 4 . K. Galbraith, The Listener, December 22, 1966.