Since over 50% of the US population have gingivitis, mouthrinses serve as a valuable adjunct to brushing and flossing. The primary objective is to determine the effectiveness of the oral rinse in reducing plaque and gingivitis and improve a patient's breath
This clinical study design is a randomized, double-blind, single-treatment, parallel design with a placebo as the control. Following a screening exam, the duration of the trial will be 1 month. Oral examinations will occur at Visit 1 (baseline), and Visit 2 (4 weeks post screening). Also, at these visits, subjects will be asked keep a diary for the one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of "freshness". They will also be asked about the taste and consistency of the mouth rinse. Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI). Gingival health will be measured using the Modified Gingival Index (MGI)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
62
Experimental Oral Rinse is a proprietary formulation of GRAS ingredients
Placebo formulation without the active ingredients
Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY
Buffalo, New York, United States
Effectiveness of the oral rinse in reducing plaque
Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI).
Time frame: 4 weeks
Effectiveness of the oral rinse in reducing gingivitis
Gingival health will be measured using the Modified Gingival Index (MGI)
Time frame: 4 weeks
Effectiveness of the oral rinse in improving a patient's breath
Subjects will be asked keep a diary for one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of "freshness",
Time frame: 4 weeks
Safety evaluation of the test Oral Rinse
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 4 weeks
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