The objective of this randomized, examiner blind, parallel group, controlled clinical trial was to compare the antiplaque and antigingivitis efficacy of an essential oil-containing mouthrinse (EO) to two mouthrinses containing 0.05% Cetylpyridinium Chloride (CPC), one with alcohol and one alcohol-free, using a two-week experimental gingivitis validated-model with a 5% hydroalcohol rinse serving as the negative control. One hundred and fifty-nine subjects, 56 males and 103 females; ranging in age from 18 to 58 years in good general health were assigned to one of the four treatment groups: EO (n = 40), 0.05% CPC with alcohol (CPC a , n = 39), 0.05% CPC alcohol-free (CPC na , n = 40), and 5% hydroalcohol negative control (n = 40). The Mean Turesky Modification of the Quigley-Hein Plaque Index (PI) and the Mean Modified Gingival Index (MGI) were the primary efficacy endpoints and were evaluated at baseline and at two weeks. Following baseline examinations, subjects received a complete dental prophylaxis and began supervised rinsing with their assigned mouthrinse twice daily for two weeks, as their sole oral hygiene measure; 151 subjects completed the trial. Two weeks after baseline the EO adjusted mean PI and MGI scores were significantly lower than those of both CPC rinses and negative control (p < 0.001). In conclusion, the EO mouthrinse demonstrated significantly greater antiplaque and antigingivitis efficacy than both CPC-containing mouthrinses and the negative control.
The six negative-control dentifrices can be used to assess dentifrices considered to be effective in reducing DH. Although response ranges for commercially available negative controls varied, these results may begin to set acceptable performance ranges for control dentifrices in DH trials.
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