Clinical Study of the Effect of Two Experimental Lozenges on Oral Malodor After Single Use

Inclusion criteria

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

• Generally healthy males and females ≥ 18 years of age.
• Able to read, sign and receive a copy of the signed informed consent form.
• Organoleptic score (Odor Intensity) ≥ 2 (morning breath: at least 6-12 hours following oral hygiene, eating or drinking) at Screening Visit, based on the average ratings of at least 4 Odor Intensity judges.
• Have an OralChroma reading ≥ 125 ppb hydrogen sulfide H2S gas, vsc (at least 6-12 hours after eating or drinking or oral hygiene).
• Intra-oral cause of bad breath (non-systemic origin) as determined by health history or exam.
• Have at least 16 natural teeth.
• Agree to abstain from eating, drinking, chewing gum, and any oral hygiene at least 6-12 hours prior to evaluation of oral malodor (Screening and Baseline 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.
• Has not taken any type of probiotic supplement intended for oral health within 14 days of screening visit.

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.
• History of common food allergies (e.g. peanuts, tree nuts, milk, eggs, shellfish, fish, wheat, soybeans)
• Self-reported as pregnant or nursing.
• Self-reported serious medical conditions.
• Based on history and clinical exam: advanced periodontitis, frank caries, and mucosal diseases.
• Antibiotic or anti-inflammatory medication within 30 days of screening visit.
• Dental prophylaxis or use of chemotherapeutic antiplaque/antigingivitis oral care products or tooth bleaching within 7 days of screening visit.
• Smoker and/or user of smokeless tobacco products.
• Orthodontic appliances, peri/oral piercings, or removable partial dentures.
• Significant oral soft tissue pathology based on a visual examination.
• Acute sinusitis or severe oral-pharyngeal infections.
• Currently taking medications which can cause oral malodor.
• Reduced salivary flow due to pathological reasons (e.g. Sjögrens syndrome).
• Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
• Participation in any oral care clinical study, concurrently or within the 30 days of screening exams.