REPO RTS OF CO UNCILS AND BUREAUS
Council accepts Macleans Fluoride dentifrice
C o u n c il o n D e n ta l T h e r a p e u t ic s
T h e C ouncil on D ental Therapeutics has re view ed and carefully considered the data sub mitted by B eecham Products, D ivision o f Beecham , In c., in support o f the safety and effec tiven ess o f its dentifrice, M acleans Fluoride, in helping to prevent dental caries. T he active com ponent in the product is sodium monofluorophosphate, a relatively stable inorganic salt. T he C ouncil has classified the product as “ A c cep ted ” and has authorized the appropriate use o f the C ou n cil’s Seal o f A ccep tan ce in the label ing and advertising of the product. T he Council also has authorized the use o f the follow ing state ment in labeling and advertising in order that the use o f the product will be placed in an appropri ate fram ework o f good oral hygiene and regular professional care. M acleans Fluoride toothpaste has been show n to be an effectiv e d ecay-p reven tive (anticaries) dentifrice that can be o f significant value w hen used in a con scien tiou sly applied program o f oral hygiene and reg ular profession al care.
T h e M acleans Fluoride form ulation contains 0.76% sodium m onofluorophosphate, 38% cal cium carbonate, 26% glycerin, 28.8% water, 1.15% sodium lauryl sulfate, and 5.3% m iscel laneous form ulating agents including binding agents, flavors, and preservative. 966 • JADA, Vol. 92, May 1976
T he manufacturer supplied data from tw o clin ical studies that indicate that the use o f the prod uct will result in a significant reduction in the in cidence o f dental caries when com pared with a control. O ne o f the studies1 was conducted with schoolchildren, aged chiefly 9 to 11, living in a fluoridated com m unity, with supervised brush ing once a day at school and use o f the product at hom e over a period o f three school years. This study included both placebo and positive control groups. T he positive control was a sodium m on ofluorophosphate dentifrice previously accepted by the C ouncil on the basis o f clinical trials. On the basis o f total D F S increm ents, the differ ence betw een the placebo and test group was approxim ately 23%. It is o f interest that, on the basis o f proximal surfaces only, the difference was 47.5%. A second tw o-year study conducted in a non fluoridated area compared the M acleans Fluor ide product with a placebo in children chiefly 6 to 12 years o f age. On the basis of D F S incre m ents, the difference was approxim ately 23%. Similar results were obtained by each o f the tw o exam iners working independently. T he children brushed daily at school under supervision, and the product also was used at home. It should be noted that a number o f clinical studies have now been reported in the dental lit
erature, indicating that sodium monofluorophosphate at a level o f approximately 0.76% in denti frice formulations is of benefit in reducing dental caries. T hese formulations have contained a fairly large variety of abrasive systems includ ing insoluble sodium metaphosphate-dicalcium phosphate,2 insoluble sodium metaphosphatesilica,3 dicalcium phosphate dihydrate-calcium carbonate (chalk),4 calcium carbonate,5 alumi num oxide,6 and calcium pyrophosphate.7 Al though not all studies resulted in statistically sig nificant reductions in dental caries, all did show reductions when the formulations were compared with a placebo. This suggests a compatibility of the monofluorophosphate with a wide range o f abrasive system s and further suggests that laboratory studies on the availability of the in gredient may serve as an indication of the prob able clinical effectiveness of the product. Laboratory studies on aged Macleans Fluor ide dentifrice indicate some initial loss of the available fluoride during the first several months after manufacture; however, the level of fluoride
remains relatively constant from the period of six months to at least three years. The age of the product used in the clinical studies was estimated to be about six months.
1. Peterson, J.; W illiam son, L.; and Casad, R. Caries in h ib i tio n w ith MFP-calcium carbonate de n tifrice in fluo ridate d area. J Dent Res 54 (special issue):L85 abstract no. L338 A pril 1975. 2. C ouncil classifies Colgate w ith MFP (sodium m o n o flu o ro phosphate) in G roup A. JADA ?9:937 O ct 1969. 3. Kinkel, H.J., and Stolte, G. [T he action o f a sodium m orlofluo roph osph ate-bro m ochlo rop hena l-con taining paste in ch ro n ic anim al experim ents and on caries in children d u ring a 2-year period w ith unsupervised b rushing .] D eutsche Zahnarztebl 22: 455 Sept 1968. 4. Naylor, M.N., and Emslie, R.D. C linical testin g o f stannous flu o rid e and sodium m onofluorophosphate de n tifrice s in school children. B r Dent J 123:17 July 4, 1967. 5. Torrell, P. Two-year clinical tests w ith d iffe re n t m ethods of local caries-preventive flu o rin e application in Swedish sch o o l children. Acta Odontol Scand 23:287 June 1965. 6. A ndlaw , R.J., and Tucker, G.J. A de n tifrice con taining 0.8 per cent sodium m onofluorophosphate in an alum inum oxide trihydrate base. A 3-year clinical trial. B r Dent J 138:426 June 3, 1975. 7. Zacherl, W.A. Clinical evaluation o f neutral sodium fluoride, stannous fluoride, sodium m o nofluo rop hosp hate and acidulated fluoride-phosphate dentifrices. J Can Dent Assoc 38:35 Jan 1972.
REPORTS OF COUNCILS AND BUREAUS
!
JADA, Vol. 92, May 1976 ■ 967
Council accepts Macleans Fluoride dentifrice
C o u n c il o n D e n ta l T h e r a p e u t ic s
T h e C ouncil on D ental Therapeutics has re view ed and carefully considered the data sub mitted by B eecham Products, D ivision o f Beecham , In c., in support o f the safety and effec tiven ess o f its dentifrice, M acleans Fluoride, in helping to prevent dental caries. T he active com ponent in the product is sodium monofluorophosphate, a relatively stable inorganic salt. T he C ouncil has classified the product as “ A c cep ted ” and has authorized the appropriate use o f the C ou n cil’s Seal o f A ccep tan ce in the label ing and advertising of the product. T he Council also has authorized the use o f the follow ing state ment in labeling and advertising in order that the use o f the product will be placed in an appropri ate fram ework o f good oral hygiene and regular professional care. M acleans Fluoride toothpaste has been show n to be an effectiv e d ecay-p reven tive (anticaries) dentifrice that can be o f significant value w hen used in a con scien tiou sly applied program o f oral hygiene and reg ular profession al care.
T h e M acleans Fluoride form ulation contains 0.76% sodium m onofluorophosphate, 38% cal cium carbonate, 26% glycerin, 28.8% water, 1.15% sodium lauryl sulfate, and 5.3% m iscel laneous form ulating agents including binding agents, flavors, and preservative. 966 • JADA, Vol. 92, May 1976
T he manufacturer supplied data from tw o clin ical studies that indicate that the use o f the prod uct will result in a significant reduction in the in cidence o f dental caries when com pared with a control. O ne o f the studies1 was conducted with schoolchildren, aged chiefly 9 to 11, living in a fluoridated com m unity, with supervised brush ing once a day at school and use o f the product at hom e over a period o f three school years. This study included both placebo and positive control groups. T he positive control was a sodium m on ofluorophosphate dentifrice previously accepted by the C ouncil on the basis o f clinical trials. On the basis o f total D F S increm ents, the differ ence betw een the placebo and test group was approxim ately 23%. It is o f interest that, on the basis o f proximal surfaces only, the difference was 47.5%. A second tw o-year study conducted in a non fluoridated area compared the M acleans Fluor ide product with a placebo in children chiefly 6 to 12 years o f age. On the basis of D F S incre m ents, the difference was approxim ately 23%. Similar results were obtained by each o f the tw o exam iners working independently. T he children brushed daily at school under supervision, and the product also was used at home. It should be noted that a number o f clinical studies have now been reported in the dental lit
erature, indicating that sodium monofluorophosphate at a level o f approximately 0.76% in denti frice formulations is of benefit in reducing dental caries. T hese formulations have contained a fairly large variety of abrasive systems includ ing insoluble sodium metaphosphate-dicalcium phosphate,2 insoluble sodium metaphosphatesilica,3 dicalcium phosphate dihydrate-calcium carbonate (chalk),4 calcium carbonate,5 alumi num oxide,6 and calcium pyrophosphate.7 Al though not all studies resulted in statistically sig nificant reductions in dental caries, all did show reductions when the formulations were compared with a placebo. This suggests a compatibility of the monofluorophosphate with a wide range o f abrasive system s and further suggests that laboratory studies on the availability of the in gredient may serve as an indication of the prob able clinical effectiveness of the product. Laboratory studies on aged Macleans Fluor ide dentifrice indicate some initial loss of the available fluoride during the first several months after manufacture; however, the level of fluoride
remains relatively constant from the period of six months to at least three years. The age of the product used in the clinical studies was estimated to be about six months.
1. Peterson, J.; W illiam son, L.; and Casad, R. Caries in h ib i tio n w ith MFP-calcium carbonate de n tifrice in fluo ridate d area. J Dent Res 54 (special issue):L85 abstract no. L338 A pril 1975. 2. C ouncil classifies Colgate w ith MFP (sodium m o n o flu o ro phosphate) in G roup A. JADA ?9:937 O ct 1969. 3. Kinkel, H.J., and Stolte, G. [T he action o f a sodium m orlofluo roph osph ate-bro m ochlo rop hena l-con taining paste in ch ro n ic anim al experim ents and on caries in children d u ring a 2-year period w ith unsupervised b rushing .] D eutsche Zahnarztebl 22: 455 Sept 1968. 4. Naylor, M.N., and Emslie, R.D. C linical testin g o f stannous flu o rid e and sodium m onofluorophosphate de n tifrice s in school children. B r Dent J 123:17 July 4, 1967. 5. Torrell, P. Two-year clinical tests w ith d iffe re n t m ethods of local caries-preventive flu o rin e application in Swedish sch o o l children. Acta Odontol Scand 23:287 June 1965. 6. A ndlaw , R.J., and Tucker, G.J. A de n tifrice con taining 0.8 per cent sodium m onofluorophosphate in an alum inum oxide trihydrate base. A 3-year clinical trial. B r Dent J 138:426 June 3, 1975. 7. Zacherl, W.A. Clinical evaluation o f neutral sodium fluoride, stannous fluoride, sodium m o nofluo rop hosp hate and acidulated fluoride-phosphate dentifrices. J Can Dent Assoc 38:35 Jan 1972.
REPORTS OF COUNCILS AND BUREAUS
!
JADA, Vol. 92, May 1976 ■ 967
