Effect of an Investigational Lozenge (Biofresh® 4plus) Versus Placebo Control on Oral Malodor (Intra-Oral Halitosis)

This randomized, placebo controlled, double-blind, crossover study will use gas chromatography (GC) and oral microbial measurements to evaluate the reduction and control of intra-oral halitosis by an investigational lozenge containing the enzyme polyphenol oxidase and green coffee extract compared to a placebo control lozenge. A one-week washout period will precede the first crossover period and a one-week washout period will be implemented between periods 1 and 2. The study will consist of five study visits: Screening Visit, Period 1 Baseline Visit, Crossover Period 1 Day 8 Visit, Period 2 Baseline Visit, Crossover Period 2 Day 8 Visit.

To be eligible for study participation, subjects must meet the following criteria:

Inclusion criteria

• Generally healthy males and females ≥18 years of age.
• Able to read, sign and receive a copy of the signed informed consent form.
• Have an average OralChroma™ reading ≥ 125 ppb hydrogen sulfide (H2S gas), volatile sulfur compound (VSC), based on 2 VSC measurements at Screening (Visit 1) and Baseline (Visit each 2 and 4), at least 12 hours after eating or drinking or oral hygiene.
• Difference of the hydrogen sulfide gas readings is ≤ 500 ppb following the two mouth air samples for each VSC measurement for Screening (Visit 1) and Baseline (Visits 2 and 4).
• Intra-oral cause of bad breath (non-systemic origin) as determined by health history or exam.
• Have at least 18 natural teeth.
• Agree to abstain from eating, drinking, breath mints, chewing gum, and any oral hygiene for at least 12 hours prior to evaluation of oral malodor at Screening, Baseline and Day 8 visits.
• Agree to avoid drinking alcohol beverages and eating spicy foods, garlic and onions, cabbage, spices, cauliflower, and radishes (sulfur compounds) 48 hours prior to each study visit.
• Agree to refrain from tongue brushing/cleaning for the duration of the study.
• Adequate oral hygiene and no signs of oral neglect.

Exclusion criteria

Subjects presenting with any of the following will not be included in the study:

• History of allergy or significant adverse effects following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
• History of allergies to ingredients in the test product.
• Self-reported as pregnant or nursing.
• Self-reported serious medical conditions.
• Based on history and clinical exam: advanced and/or untreated periodontitis, frank caries, and mucosal diseases.
• Antibiotic or anti-inflammatory medication within 30 days of screening visit.