A Clinical Study to Examine the Effects of an Experimental Toothpaste Compared to a Regular Fluoride Toothpaste on Breath Odor in a Population With Gingivitis

Exclusion Criteria

• •Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
• •Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of study entry and/or during study participation or who has previously been enrolled in this study.
• •Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• •A Participant who is pregnant (self-reported) or intending to become pregnant during the study.
• •Participant who is breastfeeding.
• •Participant who habitually smokes, uses tobacco products or who vapes.
• •Participant with known or suspected intolerance or hypersensitivity to the study products or any of their stated ingredients (or closely related compounds).
• •Participant who is unwilling or, in the opinion of the investigator or medically qualified designee, unable to comply with the requirements and/or Lifestyle Considerations of the study.
• •Participant with a recent history (within the last year) of alcohol or other substance abuse.
• •General medical exclusions:
• •1. Participant with a medical history that may prevent the Participant from participating in the study until study conclusion.
• •2. Participant with, or having recent history of, bronchitis, tonsillitis or sinusitis (within 6 weeks) or any other systemic condition that can cause oral malodor for example, xerostomia, chronic acid reflux, Type 1 diabetes, Crohn's disease, celiac disease or liver/kidney conditions.
• •3. Participant with a significant infectious disease, such as hepatitis, COVID-19, flu, respiratory infection, tuberculosis, or any other condition which can be transmitted in saliva or salivary aerosols which, in the opinion of the examiner, could endanger the organoleptic assessors.
• •4. Participant with any condition that impacts gum health (for example, Type 2 Diabetes).
• •General medication exclusions:
• •1. Participant using any antibiotic medication within 14 days prior to screening or at any time during the study.
• •2. Participant using chlorhexidine, cetylpyridinium chloride (CPC) or stannous fluoride containing mouthwash or dentifrice within 14 days prior to Visit 2 or between Visit 2 and 3.
• •3. Participant taking medications which may impact oral mouth odor (for example, Diazepam, Alprazolam, Lorazepam and so on).
• •General oral exclusions:
• •1. Participant with orthodontic or prosthetic appliances (fixed or removable), including dental implants.
• •2. Participant having had professional dental cleaning (oral prophylaxis) within 3 months prior to the screening visit or at any time during the study.
• •3. Participant with signs of active periodontal disease (with probing depth greater than \[\>\]3 millimeter \[mm\]) or who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.
• •4. Participant who has had oral surgery or tooth extraction within 6 weeks of the screening visit.
• •5. Participant who has dental conditions or disease under active dental treatment or requiring immediate treatment.
• •6. Participant with tongue or lip piercing.
• •7. Participant with Oral Soft Tissue (OST) examination findings at Screening which, in the opinion of the investigator, could interfere with the conduct of the study (for example, stomatitis, open sores, lesions, cavitied caries lesions, redness or swelling).
• •8. Participant who does not practice daily oral care.
• •Participant with oral malodor which, in the opinion of the investigator, is not expected to respond to treatment with an over-the-counter dentifrice.
• •Participant who, in the opinion of the investigator, should not participate in the study.