Abstract
BackgroundThe efficacy of several variants of essential oil mouthrinses has been studied extensively. This is the first study to compare the anti-plaque and anti-gingivitis efficacy of two marketed essential oil mouthrinses: one is an alcohol containing mouthrinse and the other one is an alcohol-free mouthrinse.MethodsThis examiner-blind, parallel-group study randomized subjects to three groups: 1) Mechanical Oral Hygiene (MOH) only; 2) MOH plus Alcohol-Containing essential oil Mouthrinse (ACM); 3) MOH plus Alcohol-Free essential oil Mouthrinse (AFM). Primary endpoint was whole-mouth mean Modified Gingival Index (MGI) at six months. Secondary endpoints included whole-mouth mean MGI at one and three months, and whole-mouth mean Plaque Index (PI) and whole-mouth mean Bleeding Index (BI) at one, three and six months. Safety assessments were conducted at all time points.ResultsA total of 370 subjects were enrolled; 348 subjects completed the study. After six months, subjects using essential oil mouthrinses with or without alcohol showed significant reduction (p < 0.001) in gingivitis (28.2% and 26.7%, respectively) and significant reduction (p < 0.001) in plaque (37.8% and 37.0%, respectively), compared to those performing MOH only. Significant reductions in MGI, PI, and BI (p < 0.001) were observed at one and three months and also at six months for mean BI. No statistically significant differences were observed for all measured indices between ACM and AFM groups at any time point. Both mouthrinses were well tolerated.ConclusionsNo significant differences were observed in the efficacy of ACM and AFM to reduce plaque and gingivitis, when used in addition to MOH, over six months.Trial registrationThe trial was registered on clinicaltrials.gov on November 30, 2016. The registration number is NCT02980497.
Highlights
The efficacy of several variants of essential oil mouthrinses has been studied extensively
When used in conjunction with mechanical oral hygiene (MOH), the use of mouthrinses to help reduce plaque and gingivitis has been well documented and their efficacy is attributed to chemical agents, such as Cetylpyridinium Chloride (CPC), Chlorhexidine (CHX), and Essential Oils (EO) contained in these products [1,2,3,4,5,6,7,8,9]
123, 124, and 123 subjects were included in the MOH, Alcohol-Free EOmouthrinse (AFM), and alcohol containing EO mouthrinses (ACM) groups, respectively; 122, 121, and 122 subjects who had both baseline and post-baseline data were included in the full analysis set (FAS)
Summary
The efficacy of several variants of essential oil mouthrinses has been studied extensively. The inclusion of alcohol in mouthrinse has historically limited its use in certain patient populations, such as children, alcoholics, people with strong taste preferences, those of certain religious beliefs, and patients with oral mucositis [12]. To address these limitations, an Alcohol-Free EOmouthrinse (AFM) was developed. Its antimicrobial properties were demonstrated in vitro [13] and in vivo [14] initially This was followed by demonstration of its efficacy in reducing plaque and gingivitis in clinical trials [15, 16]. No long-term studies (i.e., at least six months in duration) have directly compared alcohol containing EO mouthrinses (ACM) to its Alcohol-Free counterpart, AFM. The objective of the current study is to compare the long-term efficacy of twice-daily rinsing with either an AFM or an ACM, in conjunction with usual MOH, for the reduction of plaque and gingivitis
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