Clinical Evaluations of an Amine Fluoride Mouthrinse on Gingival Inflammation and Plaque Accumulation
years. Only subjects not undergoing active dental treat ment were permitted to participate in this study. General Protocol Based on the initial screening exam at which time the gingival index was recorded for teeth Nos. 3,9,12,19, 25 and 28 the subjects were stratified and assigned to one of two study groups. Group I consisted of 20 individuals who were to use a mouthrinse containing amine fluorides (MJ-148-B).t Group II consisted of 20 individuals who used a mouthrinse similar in all re spects to MJ-148-B except that the amine fluorides were missing. Both products were packaged in similar containers. The examiner (N.H.S.) responsible for all documentation did not know the group assignments. The subject population did not know what agent they were using. Following the initial documentation each subject was given a thorough prophylaxis by a dental hygienist. The time spent to complete this prophylaxis ranged from 45 minutes to 4 hours. Subjects who required more than 45 minutes to complete their prophylaxis were reap pointed for a second, third or fourth visit with the hygienist. Following the prophylaxis each subject was given a supply of coded mouthrinse, a large tube of Pepsodent dentifrice, a 15 cc measuring cup and the following instructions: "Please substitute the dentifrice given to you for the one you currently use. Rinse with 15 cc of the mouthrinse once in the morning and once in the evening for the next 8 weeks. Each mouthrinsing should last 15 seconds. No rinsing, drinking, or eating should be performed for 60 minutes following mouth rinse." A l l mouthrinse use was unsupervised. The subjects were recalled 2, 4, and 8 weeks after receiving their instructions. Complete documentation was recorded at each of these visits. A n attempt was made to have each documentation visit for a particular subject at approximately the same time of day, and on the same day of the week for each subject. This was adhered to as closely as possible, but at times was disrupted by various scheduling problems. 18
by N . H . STOLLER* D.
W . COHEN*
S. L . YANKELL* prevention by mechanical, chem ical or antibacterial agents results in diminished caries and improvement in gingival health. Thus direct in volvement of plaque in both caries and periodontal disease seems well established. Fluorides are among the most active agents that prevent caries. Amine fluo ride compounds differ from inorganic fluorides, such as sodium and stannous fluoride, in that they inhibit artifi cial plaque formation at very low fluoride concentra tions. They also inhibit metabolism of sugar to acid by oral microorganisms, artifical plaque, and/or saliva. The antiplaque properties of the amine fluo rides are attributed to the cationic portion of the mole cule. This is supported by the reports of King and Walsh on the enamel protection and plaque inhi bition properties of tetradecylamine solutions. An amine fluoride mouthrinse has been tested clini cally for antiplaque effectiveness in a 4-day no oral hygiene study by Shern et a l . The amine fluoride mouthrinse significantly reduced total plaque bacterial counts without altering overall bacterial composition. Plaque surface area scores were lower in the amine fluoride group, compared to the placebo but this reduc tion was not statistically significant (0.05 < P < 0.10). The purpose of this study was to evaluate the anti plaque and antigingivitis properties of an amine fluo ride mouthrinse used as a supplement to toothbrushing, over an 8-week test period. A control group using a placebo mouthrinse similar to the amine fluoride, but containing no active agents, was also included. PLAQUE REMOVAL OR
1
2-7
8
9-10
11
2,3,12
13
14
16
Documentation The tooth numbering used throughout this article is the 1-32 system in which the teeth are numbered con secutively starting with the maxillary right third molar (1) and ending with the mandibular right molar (32). Approximately 1 week after the initial screening visit, the subjects were recalled and documented in the following manner: A . Gingivitis monitoring 1. Crevicular fluid was collected from the mesial papilla of teeth Nos. 9, 12 and 25. The tech-
MATERIAL AND METHODS
Subject
Selection
The subjects who participated in this study all had gingival inflammation discernable on the clinical level. This was assured by accepting individuals who had a Loe and Silness gingival index (GI) of at least 1. The subject population consisted of 40 males with an age range of 14 to 63 years and an average age of 27.9 17
† MJ-148-B. This amine fluoride mouthrinse contains a 1:1 ratio of the amine fluorides hetaflur/dectaflur. The total fluoride concen tration is 250 ppmF. A l l products used in this study were supplied by Menley & James Laboratories, Ltd, Philadelphia, Pa.
* Department of Periodontics, University of Pennsylvania, School of Dental Medicine, Philadelphia, Pa 19174.
650
Volume 48 Number 10
E v a l u a t i o n of a n A m i n e F l u o r i d e M o u t h r i n s e
nique for collecting the crevicular fluid was as follows: The teeth were isolated with cotton rolls and then gently air dried (air syringe set at 4 lb/in ) until no visible moisture was present on the tooth or gingiva in the measurement area. A filter paper strip was then introduced just into the crevice at the most coronal aspect of the mesial papillae. After 1 minute, the strip was removed from the sulcus and transferred to a gingival crevice fluid meter* for quantification of the crevicular fluid on the strip. If any blood appeared on the strip the measurement for that tooth was discounted. 2. The gingival index (GI) was then scored for teeth Nos. 3, 9, 12, 19, 25, and 28. The buccal, mesial, and lingual marginal gingiva of each tooth was examined. 2
17
Plaque Monitoring 1. The plaque index (PLI) as described by Silness and Löe was scored for teeth Nos. 3, 9, 12, 19, 25 and 28. 2. Plaque dry weight determinations were made from teeth Nos. 3, 9, 12, 19, 25 and 28. Plaque was collected from the facial, lingual and acces sible interproximal surfaces of these teeth with a Hartzel "back action chisel." The plaque from the 6 teeth was then placed in a preweighed aluminum shell crown and dried at 115°F for 48 hours. The dry plaque weight for the 6 teeth was then recorded.
651
22
of the missing values. This model considers the data in a two-way table of volunteers by teeth for each mouthrinse within each week. The least square solution pro vides the volunteer effect as well as the tooth effect needed to obtain the missing values. The computed missing values were used along with the observed val ues to give the total fluid value for each volunteer. The total fluid values were used in the analysis of covariance to obtain the results shown in Table 2. The amine fluoride mouthrinse produced a lower crevicular fluid value than the placebo at 4 and 8 weeks with statistical significance at week 4. Gingival Index Analysis of the gingival index is presented in Table 3. With this index there were no statistically significant differences between the mouthrinses. Although all val ues were lower than those obtained at baseline, no trends toward lower values were obtained during the study.
19
20
Plaque Index The analysis of the plaque index is summarized in Table 4. The observed plaque index for the amine fluoride mouthrinse was less than the placebo group at all time periods. Significantly lower scores than the placebo were obtained at the 2nd and 8th weeks of the study. P l a q u e Dry Weight The plaque dry weight values obtained as presented in Table 5, were lower for the amine fluoride mouth-
Clinical Evaluations For general assessment Kodachrome slides were taken of the buccal aspects of each subject's teeth (right, left and anterior views), at each monitoring session. RESULTS
The criteria included in this study were characterized by baseline data recorded before the mouthrinses were used. The analysis uses the baseline value of each volunteer as a covariate. The number of subjects monitored at each time period throughout the study is presented in Table 1.
TABLE 1. N u m b e r o f Subjects
Scored
Throughout
Study
Group Week of study Baseline 2 4 8
Placebo
Amine fluoride
20 18 16 18
20 16 18 18
TABLE 2. C r e v i c u l a r F l u i d
Analysis
21
Crevicular
Fluid
The crevicular gingival fluid measure for each subject is the summation of fluid from the three areas moni tored. However if blood was present in fluid, measure ments of these areas could not be used. We were therefore left with data with about 10% missing values. Because volunteers with severe gingivitis could effect discrimination, it was decided to estimate the missing values in order to obtain the total fluid for each volun teer. A regression model was used to make an estimate * Harco Electronics Ltd., Winnipeg, Canada
Group averages Week of study Placebo Baseline 2 4 8
Amine fluoride
106 99 109 77
121 99 77* 64
* Significantly less than placebo ( P < 0.05). TABLE 3. G i n g i v a l I n d e x
Analysis
Group averages Week of study Baseline 2 4 8
Placebo
Amine fluoride
1.80 1.46 1.50 1.48
1.72 1.48 1.50 1.48
652
J. Periodontol. October, 1977
Stoller, C o h e n , Yankell TABLE 4. P l a q u e I n d e x
Analysis
Group averages Week of study Placebo Baseline 2 4 8
Amine fluoride 1.28 0.74* 0.97 0.90*
1.41 1.00 1.05 1.11
* Significantly less than placebo ( P < 0.05). TABLE 5. P l a q u e D r y W e i g h t
Analysis
Group averages Week of study Placebo Baseline 2 4 8
4.3 2.7 3.2 4.5
Amine fluoride 2.4 1.7* 2.6 3.9
amine fluoride mouthrinse when compared to the pla cebo. The subjective clinical impressions agreed with both the gingival indices at the 2-week time period, i.e. all parameters used to monitor gingivitis showed an im provement from baseline after 2 weeks. After this time the three parameters differed. Compared to 2-week values the gingival index showed no trends at 4 and 8 weeks. The crevicular fluid values in the amine fluoride group decreased throughout the study; however, the crevicular fluid values in control subjects showed no consistent trend. Subjective impressions at 4 and 8 weeks indicated that the level of gingival inflammation seemed to increase almost to prestudy values. In a recent review of methods used to evaluate gingival disease, it was concluded that gingival fluid was proba bly the most sensitive and reliable method for quantita tively evaluating gingival inflammation. In this study, crevicular fluid values showed the greatest and most consistent differences between the amine fluoride and control groups. Additional studies appear warranted to relate gingival indices to responses resulting from the use of placebo or test agents. The plaque indices used in this study are both indica tions of plaque volume (i.e. thickness or weight). Re sults with both indices were similar. The PLI and the dry weight indices showed favorable trends for the test mouthrinse compared to placebo, throughout the study, with statistical significance occurring at the 2nd week of both criteria, and at the 8th week for the plaque index. Subjectively, the investigator felt that the plaque levels did not seem to change markedly throughout the study. Since the statistical analysis of the plaque indices was able to discriminate between mouthrinse effects, favoring the active rinse, this again confirmed the desir ability of objective data rather than subjective judg ments. 23
* Significantly less than placebo ( P < 0.05).
rinse than the placebo at all time periods. The values for the amine fluoride mouthrinse were significantly less than the placebo only at 2 weeks. Clinical Impressions The impressions of the investigator (N.H.S.) per forming the gingivitis and plaque indices during the study and review of kodachromes at the completion of the study were as follows: Almost all of the subjects seemed to show some decrease in the level of gingival inflammation at the 2nd week examination. Those sub jects who initially had the greatest amount of supragingival and subgingival calculus, showed the greatest im provement at week 2. A t weeks 4 and 8 the level of gingival inflammation seemed to increase almost to prestudy levels. A second review of the photographs after the code was broken did not show any apparent clinical differences between the two groups. P r o d u c t Use D u r i n g t h e
REFERENCES
Study
A survey of the subjects at the completion of the study revealed that the subjects had between 0 and 5 bottles of mouthrinse remaining at the end of the 8 week study period. The average number of bottles remaining for the entire group was 1.7 bottles per person. If every subject had used 15 cc of mouthrinse two times a day for 8 weeks he should have used 1,760 cc of rinse. Initially each subject was given nine 240 cc bottles or 2,160 cc. It would therefore be expected that each subject would have approximately 1.6 bottles of mouthrinse remaining at the end of the study. This was almost what occurred. DISCUSSION
In comparing the gingivitis parameters monitored, the gingival index did not show any preference between the 2 mouthrinses, nor was there a trend in any group with this index. Crevicular fluid, which is a gingivitis criterion, showed a favorable decreasing trend for the
1. Mandel, I.: Dental Plaque: Nature, formation and ef fects. J P e r i o d o n t o l 37: 357, 1966. 2. Shern, R . J . , Swing, W. K . , and Crawford, J. J.: Pre vention of plaque formation by organic fluorides. J O r a l M e d 25: 93, 1970. 3. Swing, W. K . , and Crawford, J. J.: Inhibition of plaque-forming streptococci and diptheroids by organic com pounds. I A D R Abstract
208,
1971.
4. Yankell, S. L . , Kavanagh, B . J . , Murphy, C . V . , and M . M . Dolan: Artifical plaque prevention with aminefluorides. I A D R Abstract
207,
1971.
5. Kavanagh, B. J . , Murphy, C . V . , Dolan, M . M . , and Yankell, S. L . : Artificial plaque prevention with fluorides: Comparison of teeth with nichrome wires. I A D R A b s t r a c t 829,1972. 6. Dolan, M . M . , Kavanagh, B . J . , and Yankell, S. L . : Artifical plaque prevention with organic fluorides. J P e r i o d o n t o l 43: 561,1972. 7. Kavanagh, B . J . , Murphy, C . V . , Dolan, M . M . , and Yankell, S. L . : Artifical plaque prevention with fluorides: Comparison of teeth with nichrome wires. J P e r i o d o n o l 45: 314, 1974. 8. Muhlemann, H . R . : Die kariesprophylaktische Wirking
Volume 48 Number 10
E v a l u a t i o n of a n A m i n e F l u o r i d e M o u t h r i n s e
der Aminfluoride —10 Jahre Erfahrungen. d i e Q u i n t e s s e n z 18: no 5-8, 1967. 9. Dolan, M . M . , Murphy, C . V . , Kavanagh, B . J. and Yankell, S. L . : In vitro antiplaque activity of amine fluorides in human saliva concentrate. I A D R A b s t r a c t 827, 1972. 10. Dolan, M . M . , Murphy, C . V . , Kavanagh, B . J . , and Yankell, S. L . : Effects of fluoride in the in vitro plaque model system from human salivary sediment. J D e n t Res 52: 1323, 1973. 11. Dolan, M . M . , Harding, E . T . and Yankell, S. L . : Salivary glycolysis after mouthrinses. H e l v O d o n t o l A c t a 18: 54, 1974. 12. Shern, R. J . , and Rundell, B.: Absorption of cationic antiseptics on tooth enamel. I A D R A b s t r a c t 401, 1972. 13. King, R. M . : A clinical study of the effects of tetradecylamine on plaque formation. J D e n t Res 30: 399, 1951. 14. Walsh, J. P.: The relationships of surface active agents, the enamel surface and dental caries. A d v O r a l B i o l 1: 297, 1963. 15. Keyes, P. H . , and McCabe, R. M . : The potential of various compounds to suppress microorganisms in plaque produced in vitro by a streptococcus or an actinomycete, J A m D e n t Assoc 86: 396, 1973.
16. Shern, R. J . , Rundell, B . B . , and DeFever, C . J.: Effect of an amine fluoride mouthrinse on the formation and microbial content of plaque. H e l v O d o n t o l A c t a 18: 57,1974. 17. L ö e , H . and Silness, J.: Periodontal Disease in Preg nancy I Prevalence and Severity. J A c t a O d o n t o l S c a n d 21: 533, 1963. 18. Jamison, H . : P r e v a l e n c e o f P e r i o d o n t a l D i s e a s e i n a S a m p l e P o p u l a t i o n (This article appeared as a typed thesis). Ann Arbor, Mich, University of Michigan, School of Public Health, 1960. 19. Silness, J . , and L ö e , H . : Periodontal disease in preg nancy, II Correlation between oral hygiene and periodontal condition. A c t a O d o n t o l S c a n d 22: 121, 1964. 20. Lobene, R. J.: A clinical study of the effect of dextranase on human dental plaque. A m D e n t Assoc 82: 132, 1970. 21. S t a t i s t i c a l M e t h o d s . Snedecor, G . W. and Cochran, W. G . (eds), Ames, Iowa, Iowa State University Press, 1967. 22. S t a t i s t i c a l T h e o r y i n R e s e a r c h . Anderson, R. L . and Bancroft, T . A . , (eds), New York, McGraw Hill Book Co., 1952. 23. T h e C r e v i c u l a r F l u i d , C i m a s o n i , G . M o n o g r a p h s i n O r a l S c i e n c e , vol. 3, New York, S. Karger, 1974.
Announcements BOSTON UNIVERSITY SCHOOL OF G R A D U A T E D E N T I S T R Y , DIVISION O F C O N T I N U I N G E D U C A T I O N , C O U R S E OFFERINGS F O R F A L L 1 9 7 7 PERIODONTICS FOR THE GENERAL PRACTITIONER-HENRY M . GOLDMAN, D . M . D . Dean Emeritus of the School, Professor of Stomatology. 1. Understanding Periodontal Disease and Its Treatment—Septem ber 7 - 8 , 1 9 7 7 - F E E : $ 1 6 0 . 2. Preparation of a Case for Treatment—October 2 1 - 2 2 , 1 9 7 7 FEE: $ 1 6 0 . 3. Definitive Periodontal Therapy—December 8 - 1 0 , 1977 —FEE: $240.
PREDICTABLE COMPLETE DENTURE SERVICE — September 2 8 , 1977-CHARLES PARASKIS, D . M . D . - F E E : $ 8 0 . THIRD PARTY OFFICE MANAGEMENT OF "My Forms Are Already Filled Out . . ." -LEONARD J . Tocci, D . M . D . - F E E : $ 8 0 . DENTO-FACIAL ORTHOPEDICS — September 29-October 1, 1977 — PHILIP H . LEVY, D . D . S . - F E E : $250. ELECTROSURGERY IN DAILY DENTAL PRACTICE — September 30-October 1, 1977-DANIEL STRONG, D . M . D . - F E E : $ 1 5 0 . PARTICIPATION COURSE IN FABRICATION OF PEDODONTIC APPLI ANCES FOR MIXED DENTITION ORTHODONTIC THERAPY—October 5-7, 1 9 7 7 - J O N T . KAPALA, D . M . D . , M . S C . D . - F E E : $225. MODERN RADIOLOGY TECHNIQUES FOR THE DENTAL AUXILIARY— October 12, 1977-HERBERT HODESS, D . M . D . - F E E : $ 4 5 . OCCLUSAL ADJUSTMENT IN THE NATURAL DENTITION—October 1 3 - 1 4 , 1977-HYMAN SMUCKLER, D . M . D . , H . D . D . , GERALD M . KRAMER, D . M . D . , THOMAS MONE, D . M . D . - F E E : $ 1 6 0 . RESTORATIVE DENTISTRY AND PERIODONTICS FOR THE ADVANCED GENERAL PRACTITIONER — October 1 5 , 1977 —HOWARD M . SKUROW, D . D . S . , MYRON NEVINS, D . D . S . - F E E : $ 8 0 . CLINICAL SOLUTIONS FOR THE TREATMENT OF ENDODONTIC-PERIO DONTIC RELATED PROBLEMS — October 2 7 - 2 8 , 1 9 7 7 —HERBERT SCHILDER, D . D . S . , GERALD A . ISENBERG, D . D . S . - F E E : $ 1 6 0 .
PERIODONTICS FOR THE DENTAL HYGIENIST—November 3 0 , 1977 — NICHOLAS DELLO Russo, D . M . D . , M.Sc.D., GARY M . REISER, D.D.S.-FEE: $55. PERIODONTAL SURGERY—November 1 0 - 1 1 , 1 9 7 7 —GERALD A . IS ENBERG, D . D . S . , ALAN M . SHUMAN, D . M . D . - F E E : $ 1 6 0 . MANAGEMENT OF CLINICAL PROBLEMS: "What to Do When . . . " — December 3 , 1977 —HENRY M . GOLDMAN, D . M . D . , HERBERT SCHILDER, D.D.S., LEO TALKOV, D . M . D . , - F E E : $ 8 0 . CLINICAL PERIODONTAL SURGERY—December 1 - 3 , .1977 —GERALD M . KRAMER, D . M . D . , J . DAVID KOHN, D . D . S . - F E E : $250. PERIODONTAL PROSTHESIS — December 5 - 7 , 1977 —GERALD M . KRAMER, D . M . D . , MYRON NEVINS, D.D.S., HOWARD M . SKUROW, D . D . S . - F E E : $240. For further information contact: Program Coordinator, Division of Continuing Education, Boston University School of Graduate Dentistry, 100 E . Newton St., Boston, Mass 0 2 1 1 8 . Tel.: (617)2476354.
T E M P L E UNIVERSITY SCHOOL O F DENTISTRY Temple University School of Dentistry announces the Continuing Education course: TITLE: Adult Tooth Movement DATE: December 1 5 , 16, 1977 FACULTY: DR. ALLAN SCHLOSSBERG, D . M . D . , M . S . , Associate Pro fessor, Department of Periodontology, Temple Univer sity School of Dentistry Tooth movement is indicated for many adult patients as a part of their comprehensive dental treatment. The course will consist of lectures, demonstrations, and lab sessions. For further information contact: The Office of Continuing Educa tion, Temple University School of Dentistry, 3223 N . Broad St., Philadelphia P A 1 9 1 4 0 (215-221-2955)
years. Only subjects not undergoing active dental treat ment were permitted to participate in this study. General Protocol Based on the initial screening exam at which time the gingival index was recorded for teeth Nos. 3,9,12,19, 25 and 28 the subjects were stratified and assigned to one of two study groups. Group I consisted of 20 individuals who were to use a mouthrinse containing amine fluorides (MJ-148-B).t Group II consisted of 20 individuals who used a mouthrinse similar in all re spects to MJ-148-B except that the amine fluorides were missing. Both products were packaged in similar containers. The examiner (N.H.S.) responsible for all documentation did not know the group assignments. The subject population did not know what agent they were using. Following the initial documentation each subject was given a thorough prophylaxis by a dental hygienist. The time spent to complete this prophylaxis ranged from 45 minutes to 4 hours. Subjects who required more than 45 minutes to complete their prophylaxis were reap pointed for a second, third or fourth visit with the hygienist. Following the prophylaxis each subject was given a supply of coded mouthrinse, a large tube of Pepsodent dentifrice, a 15 cc measuring cup and the following instructions: "Please substitute the dentifrice given to you for the one you currently use. Rinse with 15 cc of the mouthrinse once in the morning and once in the evening for the next 8 weeks. Each mouthrinsing should last 15 seconds. No rinsing, drinking, or eating should be performed for 60 minutes following mouth rinse." A l l mouthrinse use was unsupervised. The subjects were recalled 2, 4, and 8 weeks after receiving their instructions. Complete documentation was recorded at each of these visits. A n attempt was made to have each documentation visit for a particular subject at approximately the same time of day, and on the same day of the week for each subject. This was adhered to as closely as possible, but at times was disrupted by various scheduling problems. 18
by N . H . STOLLER* D.
W . COHEN*
S. L . YANKELL* prevention by mechanical, chem ical or antibacterial agents results in diminished caries and improvement in gingival health. Thus direct in volvement of plaque in both caries and periodontal disease seems well established. Fluorides are among the most active agents that prevent caries. Amine fluo ride compounds differ from inorganic fluorides, such as sodium and stannous fluoride, in that they inhibit artifi cial plaque formation at very low fluoride concentra tions. They also inhibit metabolism of sugar to acid by oral microorganisms, artifical plaque, and/or saliva. The antiplaque properties of the amine fluo rides are attributed to the cationic portion of the mole cule. This is supported by the reports of King and Walsh on the enamel protection and plaque inhi bition properties of tetradecylamine solutions. An amine fluoride mouthrinse has been tested clini cally for antiplaque effectiveness in a 4-day no oral hygiene study by Shern et a l . The amine fluoride mouthrinse significantly reduced total plaque bacterial counts without altering overall bacterial composition. Plaque surface area scores were lower in the amine fluoride group, compared to the placebo but this reduc tion was not statistically significant (0.05 < P < 0.10). The purpose of this study was to evaluate the anti plaque and antigingivitis properties of an amine fluo ride mouthrinse used as a supplement to toothbrushing, over an 8-week test period. A control group using a placebo mouthrinse similar to the amine fluoride, but containing no active agents, was also included. PLAQUE REMOVAL OR
1
2-7
8
9-10
11
2,3,12
13
14
16
Documentation The tooth numbering used throughout this article is the 1-32 system in which the teeth are numbered con secutively starting with the maxillary right third molar (1) and ending with the mandibular right molar (32). Approximately 1 week after the initial screening visit, the subjects were recalled and documented in the following manner: A . Gingivitis monitoring 1. Crevicular fluid was collected from the mesial papilla of teeth Nos. 9, 12 and 25. The tech-
MATERIAL AND METHODS
Subject
Selection
The subjects who participated in this study all had gingival inflammation discernable on the clinical level. This was assured by accepting individuals who had a Loe and Silness gingival index (GI) of at least 1. The subject population consisted of 40 males with an age range of 14 to 63 years and an average age of 27.9 17
† MJ-148-B. This amine fluoride mouthrinse contains a 1:1 ratio of the amine fluorides hetaflur/dectaflur. The total fluoride concen tration is 250 ppmF. A l l products used in this study were supplied by Menley & James Laboratories, Ltd, Philadelphia, Pa.
* Department of Periodontics, University of Pennsylvania, School of Dental Medicine, Philadelphia, Pa 19174.
650
Volume 48 Number 10
E v a l u a t i o n of a n A m i n e F l u o r i d e M o u t h r i n s e
nique for collecting the crevicular fluid was as follows: The teeth were isolated with cotton rolls and then gently air dried (air syringe set at 4 lb/in ) until no visible moisture was present on the tooth or gingiva in the measurement area. A filter paper strip was then introduced just into the crevice at the most coronal aspect of the mesial papillae. After 1 minute, the strip was removed from the sulcus and transferred to a gingival crevice fluid meter* for quantification of the crevicular fluid on the strip. If any blood appeared on the strip the measurement for that tooth was discounted. 2. The gingival index (GI) was then scored for teeth Nos. 3, 9, 12, 19, 25, and 28. The buccal, mesial, and lingual marginal gingiva of each tooth was examined. 2
17
Plaque Monitoring 1. The plaque index (PLI) as described by Silness and Löe was scored for teeth Nos. 3, 9, 12, 19, 25 and 28. 2. Plaque dry weight determinations were made from teeth Nos. 3, 9, 12, 19, 25 and 28. Plaque was collected from the facial, lingual and acces sible interproximal surfaces of these teeth with a Hartzel "back action chisel." The plaque from the 6 teeth was then placed in a preweighed aluminum shell crown and dried at 115°F for 48 hours. The dry plaque weight for the 6 teeth was then recorded.
651
22
of the missing values. This model considers the data in a two-way table of volunteers by teeth for each mouthrinse within each week. The least square solution pro vides the volunteer effect as well as the tooth effect needed to obtain the missing values. The computed missing values were used along with the observed val ues to give the total fluid value for each volunteer. The total fluid values were used in the analysis of covariance to obtain the results shown in Table 2. The amine fluoride mouthrinse produced a lower crevicular fluid value than the placebo at 4 and 8 weeks with statistical significance at week 4. Gingival Index Analysis of the gingival index is presented in Table 3. With this index there were no statistically significant differences between the mouthrinses. Although all val ues were lower than those obtained at baseline, no trends toward lower values were obtained during the study.
19
20
Plaque Index The analysis of the plaque index is summarized in Table 4. The observed plaque index for the amine fluoride mouthrinse was less than the placebo group at all time periods. Significantly lower scores than the placebo were obtained at the 2nd and 8th weeks of the study. P l a q u e Dry Weight The plaque dry weight values obtained as presented in Table 5, were lower for the amine fluoride mouth-
Clinical Evaluations For general assessment Kodachrome slides were taken of the buccal aspects of each subject's teeth (right, left and anterior views), at each monitoring session. RESULTS
The criteria included in this study were characterized by baseline data recorded before the mouthrinses were used. The analysis uses the baseline value of each volunteer as a covariate. The number of subjects monitored at each time period throughout the study is presented in Table 1.
TABLE 1. N u m b e r o f Subjects
Scored
Throughout
Study
Group Week of study Baseline 2 4 8
Placebo
Amine fluoride
20 18 16 18
20 16 18 18
TABLE 2. C r e v i c u l a r F l u i d
Analysis
21
Crevicular
Fluid
The crevicular gingival fluid measure for each subject is the summation of fluid from the three areas moni tored. However if blood was present in fluid, measure ments of these areas could not be used. We were therefore left with data with about 10% missing values. Because volunteers with severe gingivitis could effect discrimination, it was decided to estimate the missing values in order to obtain the total fluid for each volun teer. A regression model was used to make an estimate * Harco Electronics Ltd., Winnipeg, Canada
Group averages Week of study Placebo Baseline 2 4 8
Amine fluoride
106 99 109 77
121 99 77* 64
* Significantly less than placebo ( P < 0.05). TABLE 3. G i n g i v a l I n d e x
Analysis
Group averages Week of study Baseline 2 4 8
Placebo
Amine fluoride
1.80 1.46 1.50 1.48
1.72 1.48 1.50 1.48
652
J. Periodontol. October, 1977
Stoller, C o h e n , Yankell TABLE 4. P l a q u e I n d e x
Analysis
Group averages Week of study Placebo Baseline 2 4 8
Amine fluoride 1.28 0.74* 0.97 0.90*
1.41 1.00 1.05 1.11
* Significantly less than placebo ( P < 0.05). TABLE 5. P l a q u e D r y W e i g h t
Analysis
Group averages Week of study Placebo Baseline 2 4 8
4.3 2.7 3.2 4.5
Amine fluoride 2.4 1.7* 2.6 3.9
amine fluoride mouthrinse when compared to the pla cebo. The subjective clinical impressions agreed with both the gingival indices at the 2-week time period, i.e. all parameters used to monitor gingivitis showed an im provement from baseline after 2 weeks. After this time the three parameters differed. Compared to 2-week values the gingival index showed no trends at 4 and 8 weeks. The crevicular fluid values in the amine fluoride group decreased throughout the study; however, the crevicular fluid values in control subjects showed no consistent trend. Subjective impressions at 4 and 8 weeks indicated that the level of gingival inflammation seemed to increase almost to prestudy values. In a recent review of methods used to evaluate gingival disease, it was concluded that gingival fluid was proba bly the most sensitive and reliable method for quantita tively evaluating gingival inflammation. In this study, crevicular fluid values showed the greatest and most consistent differences between the amine fluoride and control groups. Additional studies appear warranted to relate gingival indices to responses resulting from the use of placebo or test agents. The plaque indices used in this study are both indica tions of plaque volume (i.e. thickness or weight). Re sults with both indices were similar. The PLI and the dry weight indices showed favorable trends for the test mouthrinse compared to placebo, throughout the study, with statistical significance occurring at the 2nd week of both criteria, and at the 8th week for the plaque index. Subjectively, the investigator felt that the plaque levels did not seem to change markedly throughout the study. Since the statistical analysis of the plaque indices was able to discriminate between mouthrinse effects, favoring the active rinse, this again confirmed the desir ability of objective data rather than subjective judg ments. 23
* Significantly less than placebo ( P < 0.05).
rinse than the placebo at all time periods. The values for the amine fluoride mouthrinse were significantly less than the placebo only at 2 weeks. Clinical Impressions The impressions of the investigator (N.H.S.) per forming the gingivitis and plaque indices during the study and review of kodachromes at the completion of the study were as follows: Almost all of the subjects seemed to show some decrease in the level of gingival inflammation at the 2nd week examination. Those sub jects who initially had the greatest amount of supragingival and subgingival calculus, showed the greatest im provement at week 2. A t weeks 4 and 8 the level of gingival inflammation seemed to increase almost to prestudy levels. A second review of the photographs after the code was broken did not show any apparent clinical differences between the two groups. P r o d u c t Use D u r i n g t h e
REFERENCES
Study
A survey of the subjects at the completion of the study revealed that the subjects had between 0 and 5 bottles of mouthrinse remaining at the end of the 8 week study period. The average number of bottles remaining for the entire group was 1.7 bottles per person. If every subject had used 15 cc of mouthrinse two times a day for 8 weeks he should have used 1,760 cc of rinse. Initially each subject was given nine 240 cc bottles or 2,160 cc. It would therefore be expected that each subject would have approximately 1.6 bottles of mouthrinse remaining at the end of the study. This was almost what occurred. DISCUSSION
In comparing the gingivitis parameters monitored, the gingival index did not show any preference between the 2 mouthrinses, nor was there a trend in any group with this index. Crevicular fluid, which is a gingivitis criterion, showed a favorable decreasing trend for the
1. Mandel, I.: Dental Plaque: Nature, formation and ef fects. J P e r i o d o n t o l 37: 357, 1966. 2. Shern, R . J . , Swing, W. K . , and Crawford, J. J.: Pre vention of plaque formation by organic fluorides. J O r a l M e d 25: 93, 1970. 3. Swing, W. K . , and Crawford, J. J.: Inhibition of plaque-forming streptococci and diptheroids by organic com pounds. I A D R Abstract
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4. Yankell, S. L . , Kavanagh, B . J . , Murphy, C . V . , and M . M . Dolan: Artifical plaque prevention with aminefluorides. I A D R Abstract
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5. Kavanagh, B. J . , Murphy, C . V . , Dolan, M . M . , and Yankell, S. L . : Artificial plaque prevention with fluorides: Comparison of teeth with nichrome wires. I A D R A b s t r a c t 829,1972. 6. Dolan, M . M . , Kavanagh, B . J . , and Yankell, S. L . : Artifical plaque prevention with organic fluorides. J P e r i o d o n t o l 43: 561,1972. 7. Kavanagh, B . J . , Murphy, C . V . , Dolan, M . M . , and Yankell, S. L . : Artifical plaque prevention with fluorides: Comparison of teeth with nichrome wires. J P e r i o d o n o l 45: 314, 1974. 8. Muhlemann, H . R . : Die kariesprophylaktische Wirking
Volume 48 Number 10
E v a l u a t i o n of a n A m i n e F l u o r i d e M o u t h r i n s e
der Aminfluoride —10 Jahre Erfahrungen. d i e Q u i n t e s s e n z 18: no 5-8, 1967. 9. Dolan, M . M . , Murphy, C . V . , Kavanagh, B . J. and Yankell, S. L . : In vitro antiplaque activity of amine fluorides in human saliva concentrate. I A D R A b s t r a c t 827, 1972. 10. Dolan, M . M . , Murphy, C . V . , Kavanagh, B . J . , and Yankell, S. L . : Effects of fluoride in the in vitro plaque model system from human salivary sediment. J D e n t Res 52: 1323, 1973. 11. Dolan, M . M . , Harding, E . T . and Yankell, S. L . : Salivary glycolysis after mouthrinses. H e l v O d o n t o l A c t a 18: 54, 1974. 12. Shern, R. J . , and Rundell, B.: Absorption of cationic antiseptics on tooth enamel. I A D R A b s t r a c t 401, 1972. 13. King, R. M . : A clinical study of the effects of tetradecylamine on plaque formation. J D e n t Res 30: 399, 1951. 14. Walsh, J. P.: The relationships of surface active agents, the enamel surface and dental caries. A d v O r a l B i o l 1: 297, 1963. 15. Keyes, P. H . , and McCabe, R. M . : The potential of various compounds to suppress microorganisms in plaque produced in vitro by a streptococcus or an actinomycete, J A m D e n t Assoc 86: 396, 1973.
16. Shern, R. J . , Rundell, B . B . , and DeFever, C . J.: Effect of an amine fluoride mouthrinse on the formation and microbial content of plaque. H e l v O d o n t o l A c t a 18: 57,1974. 17. L ö e , H . and Silness, J.: Periodontal Disease in Preg nancy I Prevalence and Severity. J A c t a O d o n t o l S c a n d 21: 533, 1963. 18. Jamison, H . : P r e v a l e n c e o f P e r i o d o n t a l D i s e a s e i n a S a m p l e P o p u l a t i o n (This article appeared as a typed thesis). Ann Arbor, Mich, University of Michigan, School of Public Health, 1960. 19. Silness, J . , and L ö e , H . : Periodontal disease in preg nancy, II Correlation between oral hygiene and periodontal condition. A c t a O d o n t o l S c a n d 22: 121, 1964. 20. Lobene, R. J.: A clinical study of the effect of dextranase on human dental plaque. A m D e n t Assoc 82: 132, 1970. 21. S t a t i s t i c a l M e t h o d s . Snedecor, G . W. and Cochran, W. G . (eds), Ames, Iowa, Iowa State University Press, 1967. 22. S t a t i s t i c a l T h e o r y i n R e s e a r c h . Anderson, R. L . and Bancroft, T . A . , (eds), New York, McGraw Hill Book Co., 1952. 23. T h e C r e v i c u l a r F l u i d , C i m a s o n i , G . M o n o g r a p h s i n O r a l S c i e n c e , vol. 3, New York, S. Karger, 1974.
Announcements BOSTON UNIVERSITY SCHOOL OF G R A D U A T E D E N T I S T R Y , DIVISION O F C O N T I N U I N G E D U C A T I O N , C O U R S E OFFERINGS F O R F A L L 1 9 7 7 PERIODONTICS FOR THE GENERAL PRACTITIONER-HENRY M . GOLDMAN, D . M . D . Dean Emeritus of the School, Professor of Stomatology. 1. Understanding Periodontal Disease and Its Treatment—Septem ber 7 - 8 , 1 9 7 7 - F E E : $ 1 6 0 . 2. Preparation of a Case for Treatment—October 2 1 - 2 2 , 1 9 7 7 FEE: $ 1 6 0 . 3. Definitive Periodontal Therapy—December 8 - 1 0 , 1977 —FEE: $240.
PREDICTABLE COMPLETE DENTURE SERVICE — September 2 8 , 1977-CHARLES PARASKIS, D . M . D . - F E E : $ 8 0 . THIRD PARTY OFFICE MANAGEMENT OF "My Forms Are Already Filled Out . . ." -LEONARD J . Tocci, D . M . D . - F E E : $ 8 0 . DENTO-FACIAL ORTHOPEDICS — September 29-October 1, 1977 — PHILIP H . LEVY, D . D . S . - F E E : $250. ELECTROSURGERY IN DAILY DENTAL PRACTICE — September 30-October 1, 1977-DANIEL STRONG, D . M . D . - F E E : $ 1 5 0 . PARTICIPATION COURSE IN FABRICATION OF PEDODONTIC APPLI ANCES FOR MIXED DENTITION ORTHODONTIC THERAPY—October 5-7, 1 9 7 7 - J O N T . KAPALA, D . M . D . , M . S C . D . - F E E : $225. MODERN RADIOLOGY TECHNIQUES FOR THE DENTAL AUXILIARY— October 12, 1977-HERBERT HODESS, D . M . D . - F E E : $ 4 5 . OCCLUSAL ADJUSTMENT IN THE NATURAL DENTITION—October 1 3 - 1 4 , 1977-HYMAN SMUCKLER, D . M . D . , H . D . D . , GERALD M . KRAMER, D . M . D . , THOMAS MONE, D . M . D . - F E E : $ 1 6 0 . RESTORATIVE DENTISTRY AND PERIODONTICS FOR THE ADVANCED GENERAL PRACTITIONER — October 1 5 , 1977 —HOWARD M . SKUROW, D . D . S . , MYRON NEVINS, D . D . S . - F E E : $ 8 0 . CLINICAL SOLUTIONS FOR THE TREATMENT OF ENDODONTIC-PERIO DONTIC RELATED PROBLEMS — October 2 7 - 2 8 , 1 9 7 7 —HERBERT SCHILDER, D . D . S . , GERALD A . ISENBERG, D . D . S . - F E E : $ 1 6 0 .
PERIODONTICS FOR THE DENTAL HYGIENIST—November 3 0 , 1977 — NICHOLAS DELLO Russo, D . M . D . , M.Sc.D., GARY M . REISER, D.D.S.-FEE: $55. PERIODONTAL SURGERY—November 1 0 - 1 1 , 1 9 7 7 —GERALD A . IS ENBERG, D . D . S . , ALAN M . SHUMAN, D . M . D . - F E E : $ 1 6 0 . MANAGEMENT OF CLINICAL PROBLEMS: "What to Do When . . . " — December 3 , 1977 —HENRY M . GOLDMAN, D . M . D . , HERBERT SCHILDER, D.D.S., LEO TALKOV, D . M . D . , - F E E : $ 8 0 . CLINICAL PERIODONTAL SURGERY—December 1 - 3 , .1977 —GERALD M . KRAMER, D . M . D . , J . DAVID KOHN, D . D . S . - F E E : $250. PERIODONTAL PROSTHESIS — December 5 - 7 , 1977 —GERALD M . KRAMER, D . M . D . , MYRON NEVINS, D.D.S., HOWARD M . SKUROW, D . D . S . - F E E : $240. For further information contact: Program Coordinator, Division of Continuing Education, Boston University School of Graduate Dentistry, 100 E . Newton St., Boston, Mass 0 2 1 1 8 . Tel.: (617)2476354.
T E M P L E UNIVERSITY SCHOOL O F DENTISTRY Temple University School of Dentistry announces the Continuing Education course: TITLE: Adult Tooth Movement DATE: December 1 5 , 16, 1977 FACULTY: DR. ALLAN SCHLOSSBERG, D . M . D . , M . S . , Associate Pro fessor, Department of Periodontology, Temple Univer sity School of Dentistry Tooth movement is indicated for many adult patients as a part of their comprehensive dental treatment. The course will consist of lectures, demonstrations, and lab sessions. For further information contact: The Office of Continuing Educa tion, Temple University School of Dentistry, 3223 N . Broad St., Philadelphia P A 1 9 1 4 0 (215-221-2955)
