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Evaluation of Cue Toothpaste
Evaluation of Cue Toothpaste
C O U N C IL O N D E N T A L T H E R A P E U T IC S
The Council on Dental Therapeutics has reviewed carefully the laboratory and clinical data submitted by the ColgatePalmolive Company in support of the ef fectiveness of its product, Cue toothpaste, as an agent for home use in the partial prevention of dental caries, and has classi fied the product in Group B. The Council has authorized the use of the following statement in advertisements in order that the use of the product will be placed within an appropriate framework of good oral hygiene and regular professional care: Cue has been shown to be an effec tive decay-preventive (anti-caries) dentifrice that can be of significant value when used in a conscientiously applied program of oral hygiene and regular professional care. The active ingredient in the product is stannous fluoride. The Cue formulation contains 0.4 per cent stannous fluoride, 40.6 per cent insoluble sodium metaphos phate, 5.0 per cent anhydrous dicalcium phosphate, 27.0 per cent glycerin, 22.35 per cent water and 4.65 per cent miscel laneous formulating agents including binders, foaming agents and flavors. The manufacturer has submitted data from laboratory and animal studies which are helpful in establishing the stability and activity of its product. Powdered en amel, whole extracted teeth and teeth in situ (scheduled for extraction) showed a
reduction in enamel solubility after treat ment with the dentifrice. In animal stud ies using rats and hamsters, the principals showed a reduction in caries incidence when compared with controls. Although findings of animal clinical studies cannot easily be translated into the human situa tion, evidence of this nature is not without value, and it may eventually be possible to correlate such data with the results from human clinical trials. Laboratory data indicate that stannous and fluoride ions are present in the for mulation in substantial amounts. It is the Council’s opinion that the demonstration by laboratory tests of the continued avail ability of stannous ions and of fluoride ions in a stannous fluoride dentifrice is an important prerequisite in the consid eration of this product. This finding, to gether with the extensive investigations that have been conducted with other stan nous fluoride dentifrices, provides a high degree of presumptive evidence for the Cue formulation. The Council believes, however, that the results of controlled clinical studies are still necessary to es tablish the effectiveness of any dentifrice as a caries-preventive agent. The manufacturer has supplied data from three clinical studies, each of which was of two years’ duration. These studies were conducted under varying condi tions; one involved the use of children ranging in age from 7 to 16. In this study
118/198 • T H E J O U R N A L O F THE A M E R IC A N DENTAL A S S O C IA T IO N
the brushing was supervised three times a day, and the subjects received a dental prophylaxis every six months. The data indicate a DMFS reduction in caries in cidence of approximately 37 per cent.1 A second study, conducted in a community in which the water was fluoridated at a level of 1 ppm, involved the use of chil dren ranging in age from 8 to 15 whose brushing was supervised twice a day. In this study the reduction in caries inci dence was approximately 16 per cent.2 The subjects in the third study were be tween 5 and 12 years of age, and they received no brushing supervision or pro phylaxis. In this instance, caries reduction was about 17 per cent.3 Although the re sults of each of these studies were not statistically significant at the same level of confidence, each did show a positive re duction in caries incidence for the test
group when compared with the control. In each of these studies the product was also compared with another stannous flu oride dentifrice which had been shown to be effective in clinical studies. In each instance the products were found to pro duce similar degrees of caries reduction. The manufacturer is continuing to sup ply the Council with information on addi tional clinical studies which are currently in progress. These relate to possible im provement in the formulation and will also give further information regarding the effectiveness of the product under varying conditions of use.
1. Thom as, A . E. Effect of stannous fluoride de n ti frices In children. Thesis, University o f A la b a m a . 2. M e rg e le , M . E.; Jen nings, R. E., and G asser, E. B. U np ublish e d data. 3. H enriques, B. L., Frankl, S., and A lm an , J. U npub* lished data.
C O U N C IL O N D E N T A L T H E R A P E U T IC S
The Council on Dental Therapeutics has reviewed carefully the laboratory and clinical data submitted by the ColgatePalmolive Company in support of the ef fectiveness of its product, Cue toothpaste, as an agent for home use in the partial prevention of dental caries, and has classi fied the product in Group B. The Council has authorized the use of the following statement in advertisements in order that the use of the product will be placed within an appropriate framework of good oral hygiene and regular professional care: Cue has been shown to be an effec tive decay-preventive (anti-caries) dentifrice that can be of significant value when used in a conscientiously applied program of oral hygiene and regular professional care. The active ingredient in the product is stannous fluoride. The Cue formulation contains 0.4 per cent stannous fluoride, 40.6 per cent insoluble sodium metaphos phate, 5.0 per cent anhydrous dicalcium phosphate, 27.0 per cent glycerin, 22.35 per cent water and 4.65 per cent miscel laneous formulating agents including binders, foaming agents and flavors. The manufacturer has submitted data from laboratory and animal studies which are helpful in establishing the stability and activity of its product. Powdered en amel, whole extracted teeth and teeth in situ (scheduled for extraction) showed a
reduction in enamel solubility after treat ment with the dentifrice. In animal stud ies using rats and hamsters, the principals showed a reduction in caries incidence when compared with controls. Although findings of animal clinical studies cannot easily be translated into the human situa tion, evidence of this nature is not without value, and it may eventually be possible to correlate such data with the results from human clinical trials. Laboratory data indicate that stannous and fluoride ions are present in the for mulation in substantial amounts. It is the Council’s opinion that the demonstration by laboratory tests of the continued avail ability of stannous ions and of fluoride ions in a stannous fluoride dentifrice is an important prerequisite in the consid eration of this product. This finding, to gether with the extensive investigations that have been conducted with other stan nous fluoride dentifrices, provides a high degree of presumptive evidence for the Cue formulation. The Council believes, however, that the results of controlled clinical studies are still necessary to es tablish the effectiveness of any dentifrice as a caries-preventive agent. The manufacturer has supplied data from three clinical studies, each of which was of two years’ duration. These studies were conducted under varying condi tions; one involved the use of children ranging in age from 7 to 16. In this study
118/198 • T H E J O U R N A L O F THE A M E R IC A N DENTAL A S S O C IA T IO N
the brushing was supervised three times a day, and the subjects received a dental prophylaxis every six months. The data indicate a DMFS reduction in caries in cidence of approximately 37 per cent.1 A second study, conducted in a community in which the water was fluoridated at a level of 1 ppm, involved the use of chil dren ranging in age from 8 to 15 whose brushing was supervised twice a day. In this study the reduction in caries inci dence was approximately 16 per cent.2 The subjects in the third study were be tween 5 and 12 years of age, and they received no brushing supervision or pro phylaxis. In this instance, caries reduction was about 17 per cent.3 Although the re sults of each of these studies were not statistically significant at the same level of confidence, each did show a positive re duction in caries incidence for the test
group when compared with the control. In each of these studies the product was also compared with another stannous flu oride dentifrice which had been shown to be effective in clinical studies. In each instance the products were found to pro duce similar degrees of caries reduction. The manufacturer is continuing to sup ply the Council with information on addi tional clinical studies which are currently in progress. These relate to possible im provement in the formulation and will also give further information regarding the effectiveness of the product under varying conditions of use.
1. Thom as, A . E. Effect of stannous fluoride de n ti frices In children. Thesis, University o f A la b a m a . 2. M e rg e le , M . E.; Jen nings, R. E., and G asser, E. B. U np ublish e d data. 3. H enriques, B. L., Frankl, S., and A lm an , J. U npub* lished data.