Adjunctive benefit of an essential oil–containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: A six-month study

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ABSTRACT

Background

Mechanical methods of oral hygiene can be complemented by the use of chemotherapeutic mouthrinses. The authors sought to quantify the additional benefit provided by an essential oil–, or EO–, containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly.

Methods

The authors randomly assigned patients with gingivitis to one of three treatment groups: brushing and rinsing with a control mouthrinse, or BC; brushing, flossing and rinsing with a control mouthrinse, or BFC; or brushing, flossing and rinsing with an EO–containing mouthrinse, or BFEO. Patients received a dental prophylaxis at baseline, and the authors followed them for six months.

Results

Of 246 enrolled subjects enrolled in the study, 237 subjects were evaluable at the study’s conclusion. After six months, the subjects using the BFEO regimen had statistically and clinically significant lower mean Modified Gingival Index, or MGI, scores and Plaque Index, or PI, scores than did subjects in the BC group (29.9 percent and 56.3 percent, respectively; P < .001). Subjects in the BFC group had statistically significantly lower mean MGI and PI scores than did subjects in the BC group (11.2 percent and 9.3 percent, respectively; P < .001). Subjects in the BFEO group exhibited statistically and clinically significantly lower mean scores for MGI and PI than did subjects in the BFC group (21 percent and 51.9 percent, respectively; P < .001).

Conclusions

This study confirms that for patients with gingivitis who brush and floss routinely, the adjunctive use of an EO–containing mouthrinse provides a clinically significant and meaningful additional benefit in reducing plaque and gingivitis.

Clinical Implications

An EO–containing mouthrinse is an effective adjunct to regular brushing and flossing. Therefore, the BFEO regimen can be beneficial for patients with gingival inflammation.

Section snippets

MATERIALS AND METHODS

We designed a randomized, controlled, observer-blind, parallel-group, six-month clinical trial. The design, execution and analysis of this study were in accordance with ADA Acceptance Program Guidelines on Chemotherapeutic Products for Control of Gingivitis6 and standard operating procedures for Pfizer, which comply with International Conference on Harmonisation Good Clinical Practice guidelines.15 This international standard for pharmaceutical clinical trials ensures credible and accurate data

RESULTS

To ensure against any potential bias, we determined the evaluability of all subjects before breaking any blinded codes. We provide the results from only evaluable subjects’ analyses, since the respective randomized subject analyses essentially were identical. We excluded subjects from evaluation for administrative reasons (that is, dropout or poor compliance), concomitant antibiotic use or other significant medical findings.

We enrolled 246 subjects in the study and randomly assigned them to one

DISCUSSION

The routine of twice daily brushing and once daily interdental cleaning has been the mainstay of oral hygiene recommendations by dental professionals to their patients for decades.1, 19 While long-term studies supporting this routine are relatively few in number,20, 21, 22 this regimen undoubtedly has contributed to better oral health in patients. When we consider contemporary incidence and prevalence of periodontal diseases,2, 3 however, it is apparent that adjunctive methods of plaque and

CONCLUSION

This long-term study demonstrates that the adjunctive use of an EO–containing mouthrinse twice daily provides a meaningful and clinically significant incremental benefit to a recommended regimen of brushing twice daily and flossing once daily. Dental professionals should consider recommending a brush, floss and rinse regimen to their patients when brushing and flossing are not enough to maintain gingival health.

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    Pfizer, Morris Plains, N.J, funded the study described in this article.

    1

    Dr. Sharma is the president and the dental director, BioSci Research Canada, Mississauga, Ontario.

    2

    Ms. Charles is associate director, Clinical Research, Oral Care Research and Development, Pfizer Consumer Healthcare, Pfizer, Morris Plains, N.J.

    3

    Mr. Qaqish is the manager, Clinical Operations, BioSci Research Canada, Mississauga, Ontario.

    4

    Mr. McGuire is an associate director, Statistics, Research and Development, Pfizer Consumer Healthcare, Pfizer, Morris Plains, N.J.

    5

    Mr. Galustians is vice president, Operations, BioSci Research, Canada, Mississauga, Ontario.

    6

    Dr. Kumar is vice president, Oral Care Research and Development, Pfizer Consumer Healthcare, Pfizer, Morris Plains, N.J.

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