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J Am Dent Assoc, Vol 134, No 3, 359-365.
© 2003 American Dental Association
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ADVANCES IN DENTAL PRODUCTS

The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis

A comparative study



K. BAUROTH, D.M.D., C.H. CHARLES, B.S., R.D.H., S.M. MANKODI, D.D.S., M.S.D., K. SIMMONS, B.S., Q. ZHAO, M.S. and L.D. KUMAR, Ph.D.


   ABSTRACT
TOP
 ABSTRACT
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Background. The use of dental floss has long been considered to be effective in controlling interproximal plaque and gingivitis. The authors compared this method with that of use of a mouthrinse.

Methods. Subjects with mild-to-moderate gingivitis enrolled in a long-term, six-month study. They received a dental prophylaxis and were randomized into one of the three following treatment groups: brushing and rinsing with an essential oil-containing mouthrinse (the BEO group), brushing and flossing (the BF group) and brushing and rinsing with a control rinse (the B group).

Results. A total of 326 subjects were evaluated. The BEO and BF had significantly lower (P < .001) mean interproximal Modified Gingival Index, or MGI, scores than did the B group at six months. The BEO group had lower mean interproximal Plaque Index, or PI, scores than the other two groups at both three and six months. The BF group’s mean PI score was significantly lower than the B group’s mean score at six months only. The magnitude of reductions for the BEO and the BF groups (vs. the B group) in MGI were 11.1 percent and 4.3 percent and for PI were 20.0 percent and 3.4 percent, respectively.

Conclusions. In conjunction with professional care (prophylaxis) and toothbrushing over six months, rinsing twice daily with an essential oil–containing mouthrinse was at least as good as flossing daily in reducing interproximal plaque and gingivitis.

Clinical Implications. When weighing recommendations for oral hygiene home care, clinicians should consider that an essential oil–containing mouthrinse may be a useful adjunct in patients with gingival inflammation.

Maintenance of an adequate level of daily oral hygiene is essential for the prevention and control of plaque-associated oral diseases. Studies have clearly demonstrated that the ability to control the onset or progression of periodontal diseases is enhanced by more frequent or intense episodes of plaque control instruction.1–3 However, these studies often involve levels of instruction and monitoring that may not be applicable to the majority of patients’ true home oral hygiene regimens. In fact, epidemiologic data from the United States and other countries suggest that mechanical plaque control procedures fail to achieve their theoretical potential in controlling disease for substantial numbers of people. For example, gingivitis was present in 63 percent of the adult U.S. population sampled in the Third National Health and Nutrition Examination Survey.4 In a recent study in the United Kingdom,5 72 percent of adults had visible plaque—and, notably, the subjects who cleaned their teeth immediately before examination still were found to have plaque on almost one-third of their teeth. In addition, relatively high levels of plaque and gingivitis have been found in studies of younger people in places as diverse as Sweden6 and Jordan.7 Because of the inability of many patients to maintain adequate levels of plaque control through mechanical methods alone, the use of antimicrobial mouthrinses with demonstrated antiplaque/antigingivitis effectiveness has been recommended as an adjunct to usual oral hygiene regimens.8

An essential oil–containing mouthrinse may be a useful adjunct to home care for patients with gingival inflammation.

An essential oil–containing antimicrobial mouthrinse (Cool Mint Listerine Antiseptic, Pfizer Consumer Healthcare, Morris Plains, N.J.) has been shown to be effective in reducing supragingival plaque and gingivitis in a number of six-month controlled clinical trials9–12 designed in accordance with the ADA Guidelines for Acceptance of Chemotherapeutic Products for the Control of Supragingival Dental Plaque and Gingivitis.13 In these studies, twice-daily rinsing with the essential oil mouthrinse used adjunctively to the subjects’ usual oral hygiene procedures produced gingivitis reductions of up to 35 percent and plaque reductions of up to 56 percent compared with a negative control rinse. Subsequent studies focused on interproximal sites, because it is there that the majority of periodontal disease originates.14 These studies showed that rinsing with the essential oil mouthrinse produced a 43.8 percent reduction in viable total interproximal plaque bacteria15 and a 69.9 percent reduction in recoverable streptococci.16 In addition, we conducted ad hoc analyses of the interproximal gingivitis data from several published essential oil mouthrinse studies10–12,17 and found interproximal modified gingival index,18 or MGI, percentage reductions of approximately 32 percent, which were similar to the whole-mouth findings for these studies.

Although dental floss has been the mechanical device most widely recommended for purposes of interproximal plaque control,14 surveys of oral hygiene practices have shown that only approximately 1019,20 to 40 percent21 of respondents reported the daily use of floss, in contrast to the close to 100 percent who reported daily toothbrushing.21 Thus, patients’ requisite ability and motivation to thoroughly floss sites throughout the entire mouth once daily often is lacking, leading to frustration on the part of dental professionals and patients alike.

Given the effectiveness of the essential oil mouthrinse in reducing interproximal microbial viability and gingivitis, we sought to determine the efficacy of the mouthrinse as compared with that of dental floss (the bench mark) when both were used under conditions simulating those of actual use. We recently published the results of a separate six-month clinical trial22 designed in accordance with the appropriate ADA guidelines13 to allow for a comparison between an essential oil mouthrinse and dental floss using "at least as good as" statistical criteria.23,24 In this study,22 the mouthrinse and dental floss both were significantly more effective than the negative control (P < .001) in reducing interproximal gingivitis at both the three- and six-month examination intervals, and the mouthrinse was shown to be "at least as good as" dental floss. Therefore, we conducted the study reported here using the same protocol design to determine the reproducibility of these results.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
We designed a randomized, controlled, observer-blind, parallel-group, six-month clinical trial in accordance with the appropriate ADA guidelines.13 We recruited and entered 362 subjects, aged 18 to 65 years, who met the following inclusion criteria: at least 20 intact natural teeth with scorable facial and lingual surfaces; a mean MGI18 score of ≥ 1.75; and mean Plaque Index, or PI,25 score of ≥1.95. We did not include in the tooth count third molars, teeth that were orthodontically banded or abutment teeth. Exclusion criteria included significant oral soft-tissue pathology (other than gingivitis), gross dental caries, history of allergy to oral care products, treatment with antibiotic or anti-inflammatory drugs, history of a condition requiring antibiotic coverage before undergoing invasive dental procedures, moderate or advanced periodontitis and pregnancy. We obtained approval of the study protocol and informed consent form from the Southern Institutional Review Board, Miami, and required that each subject read and sign the informed consent form before entering the study.

We assigned each enrolled subject to one of three groups according to a randomization schedule:

– the BEO group, which used a regiment of brushing plus twice-daily rinsing with an essential oil mouthrinse (Cool Mint Listerine Antiseptic, Pfizer Consumer Healthcare, Morris Plains, N.J.);
– the BF group, which used a regimen of brushing plus once-daily use of dental floss (Reach Waxed Dental Floss, Johnson & Johnson, Skillman, N.J.);
– the B group, which used a regimen of brushing plus twice-daily rinsing with a 5 percent hydro-alcohol negative control rinse.

We instructed the qualifying subjects to refrain from performing oral hygiene procedures for at least eight hours before their arrival at the clinical site for baseline examinations, which consisted of an oral soft-tissue examination and scoring of the MGI18; Turesky modification of the Quigley-Hein Plaque Index, or PI25; and bleeding index, or BI.26,27 We scored the PI at six sites per tooth.28 All the examinations and index scorings were performed by two trained dental examiners (S.M. and K.B.), with a given index for all subjects scored by a single examiner. After the baseline examinations, we performed a complete dental prophylaxis for each subject to remove plaque, stain and calculus, and instructed each subject in the use of his or her assigned regimen while supervising the first use.

Subjects in the two rinse groups rinsed with 20 milliliters for 30 seconds and were provided with a supply of coded rinse and plastic dosage measuring cups for twice-daily home use. Subjects in the floss group received flossing instruction from a dental hygienist and were required to demonstrate their ability to floss all regions of the mouth, with additional coaching provided if needed. We also provided these subjects with written flossing instructions and a supply of dental floss for once-daily home use. We instructed the subjects to use their assigned regimen in addition to their usual oral hygiene procedures for six months and issued them diaries in which to record unsupervised daily product use. We provided dentifrice (Colgate MFP, Colgate-Palmolive, New York) and a soft-textured toothbrush (Oral-B 35, Gillette, Boston) to each subject as needed. We had subjects return to the clinical site monthly, at which time the study project leader (K.S.) monitored their compliance with their assigned regimen by measuring their returned supplies and reviewing their daily diaries. She dispensed additional supplies and diaries. At three and six months, we repeated the oral soft-tissue assessment and scored gingival, plaque and bleeding indexes. In confirming the appointment, staff of the study site (Dental Products Testing, West Palm Beach, Fla.) instructed subjects to refrain from using their test products for at least four hours before these examinations to eliminate potential bias resulting from residual product odor.

Statistical methods. We compared the treatment groups with respect to age and mean baseline interproximal and full-mouth MGI, PI and BI using a one-way analysis of variance model with treatment as a factor. We used a {chi}2 test to compare the groups with respect to sex and smoking status and the Fisher exact test to compare the groups with respect to race.

The primary efficacy variables were mean interproximal MGI and PI scores. Secondary variables were interproximal BI and full-mouth MGI, PI and BI. The primary examination interval was six months after baseline. We performed demographic, baseline and efficacy analyses on data from evaluable subjects—that is, all randomized subjects with no protocol violations—as well as on data from all randomized subjects.

For each of the efficacy variables, we tested intergroup differences at three and six months using a one-way analysis of covariance model with treatment as a factor and the respective baseline value as the covariate. We tested the treatment-by-baseline interaction at the .05 level to assess heterogeneity of slopes. We compared the essential oil and flossing groups with the negative control group. Each comparison was tested at the .05 level, two-sided. In addition, we compared the essential oil mouthrinse group to the flossing group with respect to interproximal antigingivitis effectiveness using criteria with which to make an "at least as good as" determination (Figure 1Go23,24). According to Proskin and colleagues,23 for the therapeutic effect of product A to be "at least as good as" that of another product B, it must provide a level of benefit no less than would have been required for the two agents to be considered equivalent. The essential oil mouthrinse would be considered to be "at least as good as" daily flossing if the upper limit of the 90 percent confidence interval for the ratio of the mouthrinse mean over the flossing mean was less than 110 percent.



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  		Figure 1. Subjects’ interproximal mean scores on the Modified Gingival Index.

 

   RESULTS
TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 CONCLUSION
 REFERENCES
 
Three hundred twenty-four of 362 randomized subjects were evaluable at three months; 314 were evaluable at six months. Subjects were deemed nonevaluable for protocol infractions such as not returning for post-baseline evaluations, failing to comply with product usage instructions, or initiating systemic drug therapy that could influence results at the time of the three- or six-month examination. There were 108 evaluable subjects in the BEO group (essential oil mouthrinse), 108 in the BF group (flossing) and 110 in the B group (negative control rinse).

Table 1Go (page 361) presents baseline demographics for the evaluable subjects. There were no statistically significant differences among the three groups with respect to age, sex or smoking status. There were statistically significant differences in racial distribution (P = .008), with a higher percentage of African-American subjects in the BF group than in the other two groups, and a higher percentage of Hispanic subjects in the B group than the other two groups. Subjects ranged in age from 18 to 65 years with a mean age of 39.9 years, with the majority of subjects being female (62.6 percent), white (76.7 percent) and nonsmokers (75.5 percent). For randomized subjects, there were no statistically significant differences among the groups, with the exception of racial distribution, which mirrored the distribution of evaluable subjects.


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  		TABLE 1 DEMOGRAPHIC VARIABLES: ALL EVALUABLE SUBJECTS.

 
Table 2Go presents the interproximal and Table 3Go the whole-mouth mean index scores at baseline and at three and six months for the evaluable subjects. There were no differences among the groups at baseline, with the exception of mean interproximal and whole-mouth MGI scores, which were significantly higher (P ≤ .05) for the B group than were the respective means for the other two groups. For interproximal MGI, the essential oil mouthrinse was significantly more effective than was the negative control rinse (P < .001) at three and six months, with an 11.1 percent reduction at six months (Figure 1Go, Table 2Go). Flossing was significantly more effective than the negative control (P < .05) at six months, with a 4.3 percent reduction (Figure 1Go, Table 2Go). At six months, the mouthrinse was significantly more effective than flossing (P < .001) (Figure 1Go, Table 2Go). For interproximal PI, the essential oil mouthrinse was significantly more effective (P < .001) than was the negative control at three and six months, with a 20.0 percent reduction at six months, and significantly more effective (P < .001) than flossing at both intervals (Figure 2Go, Table 2Go). Flossing was significantly more effective than control at three months (P < .05) but not at six months (Figure 2Go, Table 2Go). For interproximal BI, the essential oil mouthrinse and flossing were both significantly more effective than the negative control rinse at three (P < .05) and six months (P < .001). We did not calculate BI reduction percentages in view of the small number of bleeding sites observed, but they were typical in patients with mild to moderate gingivitis.


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  		TABLE 2 INTERPROXIMAL MEAN INDEX SCORES OF EVALUABLE SUBJECTS AT BASELINE, THREE MONTHS AND SIX MONTHS.

 

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  		TABLE 3 WHOLE-MOUTH MEAN INDEX SCORES FOR EVALUABLE SUBJECTS AT BASELINE, THREE MONTHS AND SIX MONTHS.

 


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  		Figure 2. Subjects’ interproximal mean scores on the Plaque Index.

 
For whole-mouth MGI and PI, the BEO group had significantly lower mean scores than did the B group at three and six months (P < .001), with an 11.5 percent MGI and 20.7 percent PI reduction at six months (Table 3Go). The whole-mouth BI mean scores for the BEO group also were significantly lower than those for the B group (Table 3Go) at both examination intervals (P < .05).

To assess the comparative effectiveness of the essential oil mouthrinse and flossing in controlling interproximal gingivitis, a 90 percent confidence interval for the ratio of mean six-month interproximal MGI scores (mouthrinse mean over flossing mean) was constructed. This confidence interval (90.41 percent to 95.56 percent) allowed us to conclude that the essential oil mouthrinse provided a level of interproximal gingivitis control efficacy that was "at least as good as" that provided by flossing.


   DISCUSSION
TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
CONCLUSION
 REFERENCES
 
Various devices have been used over the years to assist in the removal of plaque from interproximal sites, as it has been demonstrated that toothbrushing alone does not adequately remove interproximal plaque and thereby control gingivitis.29,30 Of these devices, the daily use of dental floss has received the most attention as an effective method of interproximal cleaning.31 We conducted this six-month study to assess the relative effectiveness of daily flossing vs. that of twice-daily rinsing with an essential oil antimicrobial mouthrinse when either were used in addition to toothbrushing. We also sought to determine if the results would confirm those of a previous study using the same protocol design.

Many studies assessing the effectiveness of floss have been designed as short-term investigations and have involved intensive training and instruction, supervision or even professionally performed flossing.32–37 In this study, we attempted to simulate conditions representative of a typical dental patient’s oral hygiene instruction experience. A dental hygienist instructed the flossing group subjects in the proper use of dental floss and then required them to demonstrate their ability to satisfactorily floss all areas of their mouth, providing additional coaching when necessary. Subjects received written flossing instructions to take home. The six-month study duration was analogous to that of a typical dental office recall interval, and use of all products was unsupervised during this period.

This study demonstrated that the essential oil mouthrinse was "at least as good as" dental floss in controlling interproximal gingivitis, and thereby confirmed the results of our previous study using the same design. Although there have not been many studies comparing chemotherapeutic and mechanical control of interproximal gingivitis and plaque, it is interesting to note that an antimicrobial dentifrice has been shown to be comparable with mechanical interdental cleaning methods in reducing gingival inflammation over a seven-month period.38 Our results are consistent with those of previous studies showing the essential oil mouthrinse to be effective in reducing interproximal gingivitis,15 as well as numbers of viable interproximal plaque organisms.15,16

While the plaque reductions produced by the mouthrinse were consistent with those reported previously,9–12,17 flossing was somewhat less effective in reducing interproximal plaque levels than might be expected. The reasons for this could not be determined from the study design. However, we might hypothesize that this could result from either behavioral or technical causes. It has been shown, for example, that flossing effectiveness decreases considerably in the absence of frequent reinforcement and instruction,39 and that the motivation to floss decreases as the time since the last dental visit increases.40 It also might be that in the current study, as time went by, the subjects failed to consistently wrap the floss around the line angles of the teeth. That would mean that the plaque that was visually accessible and scored in the interproximal areas from the line angle to the contact area was at higher levels in the floss group than in the antiseptic rinse group. Therefore, it could be speculated that the actual removal and/or disturbance of interproximal plaque (under the tooth contact area) by mechanical means brought these plaque levels beneath some unknown and theoretical threshold. That in turn could have provided an effect in reducing gingivitis in the papillary regions similar to the effect seen in the antiseptic rinse group, in which visual plaque levels were lower.


   CONCLUSION
TOP
 ABSTRACT
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
REFERENCES
 
We conducted the study described in this article to establish a bench mark for the interproximal antigingivitis effectiveness of an antiseptic mouthrinse against that of the flossing component of the widely accepted oral hygiene regimen of brushing and flossing. In addition, these results lend additional support to the use of the essential oil mouthrinse as an adjunct to mechanical oral hygiene regimens. However, we do not wish to suggest that the mouthrinse should be used instead of dental floss or any other inter-proximal cleaning device. To address this issue, additional studies would be required to determine the incremental effect of using the mouthrinse specifically in addition to the routine of toothbrushing and flossing.


   FOOTNOTES
 

Dr. Bauroth is the director of dental clinical research, Dental Products Testing, West Palm Beach, Fla.


Ms. Charles is the senior manager, Clinical Studies, Oral Care, Consumer Healthcare Research & Development, Pfizer, 201 Tabor Road, Morris Plains, N.J. 07950, e-mail "chris.charles{at}pfizer.com". Address reprint requests to Ms. Charles.


Dr. Mankodi is the president and director, Dental Products Testing, West Palm Beach, Fla.


Ms. Simmons is a project leader, Dental Products Testing, West Palm Beach, Fla.


Mr. Zhao is a manager, Statistics, Consumer Healthcare Research & Development, Pfizer, Morris Plains, N.J.


Dr. Kumar is the senior director, Oral Care, Consumer Healthcare Research & Development, Pfizer, Morris Plains, N.J.


   REFERENCES
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 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 

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