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Clinical Efficacy of Powder and Paste Dentifrices
C LIN IC A L EFFICACY O F PO W D E R A N D PASTE D E N T IF R IC E S H. B. McCauley, M. J. Sheehy, D. B. Scott, P. H. Keyes, S. J. Fanale and Peter P. Dale, Rochester, N. Y. A dentifrice is an accessory to the toothbrush in cleaning surfaces of the teeth. As such, its clinical efficacy is a measure of its ability in routine dally brushing? to maintain accessible dental surfaces free of accumulations that dull the natural luster of enamel and render the oral cavity unhygienic. Deposits of varying consistency usually form on tooth surfaces that are not reg ularly and adequately cleaned. Am ong them are bacterial films of mucus and m ateria alba similar to the plaques dem onstrated by Williams1 and a structure less pigmented pellicle described by M anly.2 These accumulations, which recur variously after removal in a sig nificant percentage of adults, probably account for most of the commonly en countered deposits that may be consid ered vulnerable to toothbrushing. T h e present study is an attempt to de termine the comparative effectiveness of toothbrushing utilizing representative proprietary powder and paste dentifrices, founded on ( i ) the accumulation of pel licle during twelve days of twice daily two-minute brushing and (2) the re moval of twenty-four-hour deposits of mucinous film and inateria alba by single two-minute brushing. From the Division of Dental Research, School of Medicine and Dentistry, University of Rochester. Aided by grants of the Carnegie Corpora tion of New York, the Eastman Dental Dis pensary of Rochester and the Procter and Gamble Company. 1. Williams, J. March 1897. 2. Manly, R. S.: cember 1943.
L.:
D.
Cosmos
3 9 :169,
J. D. Res. 22:479, De
Jour. A.D.A., Vol. 33, August 1, 1946
Experimental Dentifrices selected for investigation were extensively advertised and retailed throughout the United States and were purchased on the open market. Analysis of water-insoluble ingredients by the Bu reau of Chemistry o f the Am erican D en tal Association indicated that the powder dentifrice was 70 to 75 per cent trical cium phosphate and 15 per cent calcium carbonate. T h e paste was approximately 38 per cent calcium carbonate, the only water-insoluble substance detected. Nei ther was currently acceptable to the Council on Dental Therapeutics. A l though the composition was subject to change without notice, it is not very likely that abrasive ingredients of samples employed in the study differed materially from each other or from these factors as presented in the findings o f the Bu reau o f Chemistry. T a p water em ployed as a dentifrice furnished control. T h e subjects included twenty-three men and twenty-four women, graduate students and laboratory workers of the School of M edicine and Dentistry. Selec tion was at random, no effort being made to obtain an age group or persons known to accumulate dental deposits readily. T h eir ages ranged between 16 and 40 years, the average being the late twenties. A ll had a normal complement o f anterior teeth except one, whose maxillary teeth had been replaced by fixed bridgework. T h e procedure required division of the subjects as nearly as possible into equal groups, each of which was as signed the dentifrices in turn and in such sequence that every regimen was
993
994
T
he
Jo u rn al
of th e
A
m e r ic a n
D
ental
A
s s o c ia t io n
Fig. i.— Deposition of pigm ented pellicle during twelve-day twice daily brushing test with w ater (above, left) and paste (above, right) dentifrices. Com parative removal of twenty-fourhour mucinous plaque (stained) by single brushings w ith pow der (below, left) apd w ater (below, rig h t). Crosses were inscribed in the pellicle on the central incisors (above, left).
being tested simultaneously. T h e method was designed to rule out possible sea sonal influences on the results and per mitted each person to act as his own control, thus substantially eliminating bias due to individual variations in brushing technic, dietary habits and sus ceptibility to accumulation of surface films. T h e dual test of a dentifrice required thirteen days. It began with issuing of the dentifrice, with instructions for use, and a “ hard” synthetic-bristle toothbrush of fixed design. This instrument was trimmed straight and contained twelve one-half inch twenty-five-filament tufts arranged in two equal rows to furnish a brushing surface approximately threeeighths inch wide and i T / s inches long. W ith the brush and flour of pumice, the subject was required to clean his teeth in our presence until we were satisfied
that all removable stains, plaques and food debris had been eliminated from the surfaces of the six anterior teeth of both jaws. T h e teeth were then photo graphed on 35 mm. type A Kodachrom e film, using an apparatus that permitted reproduction of exposure factors. Iden tification of pictures was secured by photographic inclusion of a label indi cating the person’s name and the serial number of the exposure. A fter the teeth were photographed, the individual was dismissed for twelve days, during which he was instructed to brush his teeth twice daily for two minutes per brushing, using the dentifrice furnished to him in suffi cient quantity to allow uniform distri bution over all the teeth throughout each brushing period. A fter the twelve-day period, the an terior teeth were examined for the pres ence of visible pellicle formation. The
M
c
C
a u l e y ê t a l .—
C
l in ic a l
relative amount o f material in the pelli cle and its distribution were recorded on a chart of the labial surface of these teeth by appropriate shading, and the teeth photographed as before. T o facili tate recognition o f the pellicle, a cross (Fig. i) was inscribed with pumice and an orangewood point on the labial sur faces of the m axillary central incisor teeth before the exposure. After its com pletion, the subject was again dismissed, this time with instructions to refrain from brushing the teeth until he reap peared for examination twenty-four hours later. A t the close of the twenty-four hour period, a mucus-disclosing solution3 con taining rose bengal, 6 parts; guinea green B, 4 parts; glycerol, 15 parts; acetic acid, 1 part, and water q.s. 600 parts was carefully applied with a cot ton swab to the labial surfaces of the anterior teeth to reveal the presence of materia alba or other accumulations of mucinous and bacterial plaque m a terial. Visual impressions were charted as previously described and the teeth were again photographed. The subject then brushed his teeth in our presence for two minutes by the clock with the assigned dentifrice; after which, the dis closing agent was reapplied, and the degree and extent of remaining plaque material were charted and the teeth rephotographed. A t this time, the teeth were thoroughly cleaned with flour of pumice in preparation for the succeeding phase of the experim ent, which was promptly begun with a different denti frice and a new toothbrush. A t the close of the experiment, beforeand-after Kodachrom e transparencies of each individual in turn were placed on a large opalescent glass illuminator for classification. Six films, the number re quired to record the effects of brushing with each of the dentifrices in either
E
f f ic a c y o f
D
995
e n t if r ic e s
the twelve-day accumulation test or the twenty-four-hour plaque removal test, were viewed at one time. Criteria for establishing the presence of deposit were ability to visualize the cross on the labial surfaces of the m axillary central incisor teeth in the accumulation test and darkly stained areas in the removal test. Films giving no evidence of deposit on accessible surfaces of the twelve anterior teeth were placed in category o. R e maining transparencies, according to the comparative degree of accumulation dis closed in them, were assigned to cate gories 1, 2 and 3. Independent tabula tion of the impressions recorded on the charts at the time that the photographs were made provided a convenient check. Findings The results are indicated in Tables 1 and 2 and in Figure 2. A ll but eight subjects satisfactorily completed the en tire experiment: O f forty-seven persons examined in twelve-day accumulation tests, twenty developed pigmented de posits. These films were gray-brown or brown and were preferentially distrib uted over the middle and incisive third of the anterior teeth. O f twenty-eight habitual tobacco smokers, seventeen de veloped the pellicle. Deposition occurred predominantly under the control (water) dentifrice régime, but was not entirely prevented by use of the commercial dentifrices in the same individuals. (Table 1.) Visible accumulations (Fig. 1 ) were present in eighteen of forty-four persons using the control dentifrice, in Table 1 .— Twelve-Day Accumulation of Pigmented Pellicle on Anterior Teeth of Persons Using Powder and Paste Dentifrices in Twice Daily Brushing
Number of Distribution of Persons Persons by Degree of Pellicle Dentifrice Examined Accumulation
Water 3. Bender, D. V .: U . S. Patent 2, 151 ,495 . Powder Paste Chem. Abstr. 33 :5132 , 1939 .
0
41 47 46
26 46 42
1
2
3
7
6 0 0
0 0
1
4
5
996
T
he
Jo u rn al
of th e
A
m e r ic a n
IZ -D a y Accum ulation of B ro w n Pellicle under Powder & Paste Dentifrice Regimes
0 D egree
I 2 . 3 o f A c c u m u l a t io n
D
ental
A
s s o c ia t io n
Rem oval of 24-H o ur Plaque by 2 -M inute Brushings with Dentifrices
<50
5 0 -1 0 0
100
100
P e r c e n t Plaque R em oved
Fig. 2.-— Distribution of subjects by degree of pigmented pellicle accumulation (left) and extent of removal of twenty-four-hour mucinous deposit (right) when powder, paste and control (water) dentifrices were used.
one of forty-seven using the powder and in four of forty-six using the paste. In the absence of toothbrushing for a twenty-four-hour period, all subjects de veloped deposits of mucinous film and materia alba as indicated by the mucusdisclosing solution. Complete removal of plaque material from accessible sur faces o f the anterior teeth by a two-minute brushing occurred in seventeen of thirty-nine subjects using water, in thirtyone of forty-two using the powder and in thirty-one of thirty-nine using the paste. (Table 2.) Photographs illustrating the comparative effects of use of the denti frices and of water as a dentifrice are presented in Figure i . Continued brushing with the paste dentifrice was associated with complaints of an inflammatory reaction of the oral mucosa, mild in twelve, moderate in eleven and severe in thirteen of fortyeight persons from their own descrip tion. O f the same individuals, ten re
ported m ild reactions, twelve moderate and five severe when using the assigned toothbrush and tap water under com parable conditions. Comment Though derived from a categorical distribution of photographs according to estimates of the degree of tooth film deposition visualized in them, the re sults agreed satisfactorily with those of a similar classification of direct im pressions charted at the time that the photographs were made. Differences be tween the percentages of individuals in which visible pellicle formation was pre vented under the powder and paste ré gimes in accumulation tests (Fig. 2, left) are probably not significant; nor are those between the percentages expressing the efficacy of the dentifrices in com pletely removing twenty-four-hour de posits of plaque material (Fig. 2, right). T h e inadequacy of water as a dentifrice
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Table 2 .— Removal of Twenty-Four-Hour Deposits of M ucinous Film and Materia Alba by Two-Minute Brushing with Powder and Paste Dentifrices
Number Dentiof frice Persons
Distribution of Persons by Extent of Removal 3rdls t Com- Deplete gree 100% 65%
Water Powder Paste
39 42 39
17 31 31
6 4 3
2nd- 3rd1st 2nd De- DeUngreegree changed 50% 35% 35% 10 5 3
3 0 0
3 2 2
Percentages represent gross approximations.
is apparent in the findings that 41 per cent of the subjects in which it was tested accumulated a pigmented pellicle in twelve days and that only 44 per cent completely removed twenty-four-hour deposits o f mucinous film and materia alba in two minutes of brushing. T h e results appear to warrant deduc tions as follows: (1) that use of an in sufficiently abrasive dentifrice favors the production of a pigmented pellicle and (2) that a dentifrice, to be clinically satisfactory, must possess some degree of abrasiveness. Confirmatory evidence may be found in reports of M anly,2 Thomssen,4 H ead5 and Howitt, Flem ing and Simonton,6 all of whom observed 4. Thomssen, E. G .: Deutsche Parfumerie Ztg. 9 :7, I 923 5. Head, J.: Modern Dentistry. Philadel phia: W. B. Saunders & Co., 1917, p. 64. 6. Howitt, Beatrice F.; Fleming, W. C., and Simonton, F. V .: Study of Effects upon Hy giene and Microbiology of Mouth of Various Diets, with and Without Use of Toothbrush. D. Cosmos 7 0 : 575 , June 1928.
E f f ic a c y
of
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e n t if r ic e s
997
pellicles under conditions similar to those under which pigmented pellicles were produced in this experiment. A c cording to M anly, if the abrasiveness, as regards dentin, of the' powder dentifrice used in this study were arbitrarily fixed at 100, the paste might be expected to register 90, and water, by the same rea soning, would be 0. Inflammatory reactions of the oral mucosa to brushing with the paste den tifrice might lead one to anticipate de crease of its effectiveness. No such in fluence is readily apparent in the find ings. Summary A powder and a paste dentifrice were subjected to clinical tests for efficacy in forty-seven adults. These tests were founded on the accumulation of a pig mented pellicle during twelve days of twice-daily two-minute toothbrushing, and the removal of twenty-four-hour de posits of mucinous film and materia alba by a single two-minute brushing. T w o per cent of persons using the powder and 8 per cent using the paste developed pigmented pellicles in the twelve-day test. U sing the control dentifrice of tap water, 41 per cent produced similar deposits. Complete removal of twentyfour-hour accretions by two-minute brushings occurred in 74 per cent of subjects using the powder; in 79 per cent using the paste, and in 44 per cent using the water. Use of an insufficiently abrasive dentifrice favors the produc tion of a pigmented pellicle.— School of M edicine and Dentistry, University of Rochester.
L.:
D.
Cosmos
3 9 :169,
J. D. Res. 22:479, De
Jour. A.D.A., Vol. 33, August 1, 1946
Experimental Dentifrices selected for investigation were extensively advertised and retailed throughout the United States and were purchased on the open market. Analysis of water-insoluble ingredients by the Bu reau of Chemistry o f the Am erican D en tal Association indicated that the powder dentifrice was 70 to 75 per cent trical cium phosphate and 15 per cent calcium carbonate. T h e paste was approximately 38 per cent calcium carbonate, the only water-insoluble substance detected. Nei ther was currently acceptable to the Council on Dental Therapeutics. A l though the composition was subject to change without notice, it is not very likely that abrasive ingredients of samples employed in the study differed materially from each other or from these factors as presented in the findings o f the Bu reau o f Chemistry. T a p water em ployed as a dentifrice furnished control. T h e subjects included twenty-three men and twenty-four women, graduate students and laboratory workers of the School of M edicine and Dentistry. Selec tion was at random, no effort being made to obtain an age group or persons known to accumulate dental deposits readily. T h eir ages ranged between 16 and 40 years, the average being the late twenties. A ll had a normal complement o f anterior teeth except one, whose maxillary teeth had been replaced by fixed bridgework. T h e procedure required division of the subjects as nearly as possible into equal groups, each of which was as signed the dentifrices in turn and in such sequence that every regimen was
993
994
T
he
Jo u rn al
of th e
A
m e r ic a n
D
ental
A
s s o c ia t io n
Fig. i.— Deposition of pigm ented pellicle during twelve-day twice daily brushing test with w ater (above, left) and paste (above, right) dentifrices. Com parative removal of twenty-fourhour mucinous plaque (stained) by single brushings w ith pow der (below, left) apd w ater (below, rig h t). Crosses were inscribed in the pellicle on the central incisors (above, left).
being tested simultaneously. T h e method was designed to rule out possible sea sonal influences on the results and per mitted each person to act as his own control, thus substantially eliminating bias due to individual variations in brushing technic, dietary habits and sus ceptibility to accumulation of surface films. T h e dual test of a dentifrice required thirteen days. It began with issuing of the dentifrice, with instructions for use, and a “ hard” synthetic-bristle toothbrush of fixed design. This instrument was trimmed straight and contained twelve one-half inch twenty-five-filament tufts arranged in two equal rows to furnish a brushing surface approximately threeeighths inch wide and i T / s inches long. W ith the brush and flour of pumice, the subject was required to clean his teeth in our presence until we were satisfied
that all removable stains, plaques and food debris had been eliminated from the surfaces of the six anterior teeth of both jaws. T h e teeth were then photo graphed on 35 mm. type A Kodachrom e film, using an apparatus that permitted reproduction of exposure factors. Iden tification of pictures was secured by photographic inclusion of a label indi cating the person’s name and the serial number of the exposure. A fter the teeth were photographed, the individual was dismissed for twelve days, during which he was instructed to brush his teeth twice daily for two minutes per brushing, using the dentifrice furnished to him in suffi cient quantity to allow uniform distri bution over all the teeth throughout each brushing period. A fter the twelve-day period, the an terior teeth were examined for the pres ence of visible pellicle formation. The
M
c
C
a u l e y ê t a l .—
C
l in ic a l
relative amount o f material in the pelli cle and its distribution were recorded on a chart of the labial surface of these teeth by appropriate shading, and the teeth photographed as before. T o facili tate recognition o f the pellicle, a cross (Fig. i) was inscribed with pumice and an orangewood point on the labial sur faces of the m axillary central incisor teeth before the exposure. After its com pletion, the subject was again dismissed, this time with instructions to refrain from brushing the teeth until he reap peared for examination twenty-four hours later. A t the close of the twenty-four hour period, a mucus-disclosing solution3 con taining rose bengal, 6 parts; guinea green B, 4 parts; glycerol, 15 parts; acetic acid, 1 part, and water q.s. 600 parts was carefully applied with a cot ton swab to the labial surfaces of the anterior teeth to reveal the presence of materia alba or other accumulations of mucinous and bacterial plaque m a terial. Visual impressions were charted as previously described and the teeth were again photographed. The subject then brushed his teeth in our presence for two minutes by the clock with the assigned dentifrice; after which, the dis closing agent was reapplied, and the degree and extent of remaining plaque material were charted and the teeth rephotographed. A t this time, the teeth were thoroughly cleaned with flour of pumice in preparation for the succeeding phase of the experim ent, which was promptly begun with a different denti frice and a new toothbrush. A t the close of the experiment, beforeand-after Kodachrom e transparencies of each individual in turn were placed on a large opalescent glass illuminator for classification. Six films, the number re quired to record the effects of brushing with each of the dentifrices in either
E
f f ic a c y o f
D
995
e n t if r ic e s
the twelve-day accumulation test or the twenty-four-hour plaque removal test, were viewed at one time. Criteria for establishing the presence of deposit were ability to visualize the cross on the labial surfaces of the m axillary central incisor teeth in the accumulation test and darkly stained areas in the removal test. Films giving no evidence of deposit on accessible surfaces of the twelve anterior teeth were placed in category o. R e maining transparencies, according to the comparative degree of accumulation dis closed in them, were assigned to cate gories 1, 2 and 3. Independent tabula tion of the impressions recorded on the charts at the time that the photographs were made provided a convenient check. Findings The results are indicated in Tables 1 and 2 and in Figure 2. A ll but eight subjects satisfactorily completed the en tire experiment: O f forty-seven persons examined in twelve-day accumulation tests, twenty developed pigmented de posits. These films were gray-brown or brown and were preferentially distrib uted over the middle and incisive third of the anterior teeth. O f twenty-eight habitual tobacco smokers, seventeen de veloped the pellicle. Deposition occurred predominantly under the control (water) dentifrice régime, but was not entirely prevented by use of the commercial dentifrices in the same individuals. (Table 1.) Visible accumulations (Fig. 1 ) were present in eighteen of forty-four persons using the control dentifrice, in Table 1 .— Twelve-Day Accumulation of Pigmented Pellicle on Anterior Teeth of Persons Using Powder and Paste Dentifrices in Twice Daily Brushing
Number of Distribution of Persons Persons by Degree of Pellicle Dentifrice Examined Accumulation
Water 3. Bender, D. V .: U . S. Patent 2, 151 ,495 . Powder Paste Chem. Abstr. 33 :5132 , 1939 .
0
41 47 46
26 46 42
1
2
3
7
6 0 0
0 0
1
4
5
996
T
he
Jo u rn al
of th e
A
m e r ic a n
IZ -D a y Accum ulation of B ro w n Pellicle under Powder & Paste Dentifrice Regimes
0 D egree
I 2 . 3 o f A c c u m u l a t io n
D
ental
A
s s o c ia t io n
Rem oval of 24-H o ur Plaque by 2 -M inute Brushings with Dentifrices
<50
5 0 -1 0 0
100
100
P e r c e n t Plaque R em oved
Fig. 2.-— Distribution of subjects by degree of pigmented pellicle accumulation (left) and extent of removal of twenty-four-hour mucinous deposit (right) when powder, paste and control (water) dentifrices were used.
one of forty-seven using the powder and in four of forty-six using the paste. In the absence of toothbrushing for a twenty-four-hour period, all subjects de veloped deposits of mucinous film and materia alba as indicated by the mucusdisclosing solution. Complete removal of plaque material from accessible sur faces o f the anterior teeth by a two-minute brushing occurred in seventeen of thirty-nine subjects using water, in thirtyone of forty-two using the powder and in thirty-one of thirty-nine using the paste. (Table 2.) Photographs illustrating the comparative effects of use of the denti frices and of water as a dentifrice are presented in Figure i . Continued brushing with the paste dentifrice was associated with complaints of an inflammatory reaction of the oral mucosa, mild in twelve, moderate in eleven and severe in thirteen of fortyeight persons from their own descrip tion. O f the same individuals, ten re
ported m ild reactions, twelve moderate and five severe when using the assigned toothbrush and tap water under com parable conditions. Comment Though derived from a categorical distribution of photographs according to estimates of the degree of tooth film deposition visualized in them, the re sults agreed satisfactorily with those of a similar classification of direct im pressions charted at the time that the photographs were made. Differences be tween the percentages of individuals in which visible pellicle formation was pre vented under the powder and paste ré gimes in accumulation tests (Fig. 2, left) are probably not significant; nor are those between the percentages expressing the efficacy of the dentifrices in com pletely removing twenty-four-hour de posits of plaque material (Fig. 2, right). T h e inadequacy of water as a dentifrice
M
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a u l e y e t a l .—
C
l in ic a l
Table 2 .— Removal of Twenty-Four-Hour Deposits of M ucinous Film and Materia Alba by Two-Minute Brushing with Powder and Paste Dentifrices
Number Dentiof frice Persons
Distribution of Persons by Extent of Removal 3rdls t Com- Deplete gree 100% 65%
Water Powder Paste
39 42 39
17 31 31
6 4 3
2nd- 3rd1st 2nd De- DeUngreegree changed 50% 35% 35% 10 5 3
3 0 0
3 2 2
Percentages represent gross approximations.
is apparent in the findings that 41 per cent of the subjects in which it was tested accumulated a pigmented pellicle in twelve days and that only 44 per cent completely removed twenty-four-hour deposits o f mucinous film and materia alba in two minutes of brushing. T h e results appear to warrant deduc tions as follows: (1) that use of an in sufficiently abrasive dentifrice favors the production of a pigmented pellicle and (2) that a dentifrice, to be clinically satisfactory, must possess some degree of abrasiveness. Confirmatory evidence may be found in reports of M anly,2 Thomssen,4 H ead5 and Howitt, Flem ing and Simonton,6 all of whom observed 4. Thomssen, E. G .: Deutsche Parfumerie Ztg. 9 :7, I 923 5. Head, J.: Modern Dentistry. Philadel phia: W. B. Saunders & Co., 1917, p. 64. 6. Howitt, Beatrice F.; Fleming, W. C., and Simonton, F. V .: Study of Effects upon Hy giene and Microbiology of Mouth of Various Diets, with and Without Use of Toothbrush. D. Cosmos 7 0 : 575 , June 1928.
E f f ic a c y
of
D
e n t if r ic e s
997
pellicles under conditions similar to those under which pigmented pellicles were produced in this experiment. A c cording to M anly, if the abrasiveness, as regards dentin, of the' powder dentifrice used in this study were arbitrarily fixed at 100, the paste might be expected to register 90, and water, by the same rea soning, would be 0. Inflammatory reactions of the oral mucosa to brushing with the paste den tifrice might lead one to anticipate de crease of its effectiveness. No such in fluence is readily apparent in the find ings. Summary A powder and a paste dentifrice were subjected to clinical tests for efficacy in forty-seven adults. These tests were founded on the accumulation of a pig mented pellicle during twelve days of twice-daily two-minute toothbrushing, and the removal of twenty-four-hour de posits of mucinous film and materia alba by a single two-minute brushing. T w o per cent of persons using the powder and 8 per cent using the paste developed pigmented pellicles in the twelve-day test. U sing the control dentifrice of tap water, 41 per cent produced similar deposits. Complete removal of twentyfour-hour accretions by two-minute brushings occurred in 74 per cent of subjects using the powder; in 79 per cent using the paste, and in 44 per cent using the water. Use of an insufficiently abrasive dentifrice favors the produc tion of a pigmented pellicle.— School of M edicine and Dentistry, University of Rochester.