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

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of an experimental dentifrice, containing 0.454 percent (%) stannous fluoride and 0.3% zinc chloride, to reduce oral malodor, compared to a marketed regular fluoride dentifrice after 3 weeks twice daily brushing in a population of clinically diagnosed gingivitis.

Detailed Description
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This will be a single center, single blind (to the examiners undertaking the oral malodor assessments), randomized (stratified by the participant's sex), controlled, two arm parallel study in volunteers with clinically diagnosed gingivitis and oral malodor. The study will evaluate the clinical efficacy of an experimental dentifrice containing 0.454% stannous fluoride and 0.3% zinc chloride to reduce oral malodor after 3 weeks of twice-daily use compared to a regular reference dentifrice. Sufficient participants will be screened to randomize approximately 106 participants to study treatment (approximately 53 per treatment group) to ensure approximately 100 evaluable participants complete the study.

Official Title
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A Randomized, Single-Blind Clinical Study Assessing the Effects of an Experimental Dentifrice Compared to a Regular Fluoride Dentifrice on Breath Odor When Used Twice Daily for 3 Weeks in a Population With Clinically Diagnosed Gingivitis

Conditions
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Halitosis

Intervention / Treatment
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* Other: Experimental Dentifrice
* Other: Reference Dentifrice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. Participant who is willing and able to comply with scheduled visits, product usage requirements, study procedures and lifestyle restrictions. Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history (for example, a medical condition or medication confirmed to contribute to xerostomia),or upon oral examination, that would impact the participant's safety, wellbeing or the outcomes of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements. Participant with generally good oral health that fulfil all of the following: Having at least 20 natural (vital) teeth. Good oral health without lesions in the oral cavity (including the tongue) that could interfere with the study evaluations. Having clinically diagnosed, plaque-induced gingivitis defined as having 10-30% bleeding sites from the bleeding on probing assessment. At Screening (Visit 1) and prior to brushing with assigned dentifrice at Baseline (Visit 2) participants must provide 2 samples of mouth air, which must have a mean hydrogen sulfide concentration greater than 150ppb. There must be less than or equal to (<=)500ppb difference between the values measured at screening and baseline (pre-brushing). At Baseline (Visit 2), prior to brushing with assigned dentifrice participants must provide a breath sample with a mean organoleptic score greater than or equal to (>=)2. 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: Participant with a medical history that may prevent the Participant from participating in the study until study conclusion. 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. 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. Participant with any condition that impacts gum health (for example, Type 2 Diabetes). General medication exclusions: Participant using any antibiotic medication within 14 days prior to screening or at any time during the study. 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. Participant taking medications which may impact oral mouth odor (for example, Diazepam, Alprazolam, Lorazepam and so on). General oral exclusions: Participant with orthodontic or prosthetic appliances (fixed or removable), including dental implants. Participant having had professional dental cleaning (oral prophylaxis) within 3 months prior to the screening visit or at any time during the study. 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. Participant who has had oral surgery or tooth extraction within 6 weeks of the screening visit. Participant who has dental conditions or disease under active dental treatment or requiring immediate treatment. Participant with tongue or lip piercing. 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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Dentifrice<br>Participants will be instructed to brush twice daily (for 1 minute, morning and evening) with the experimental dentifrice (0.454% Stannous Fluoride with 0.3% Zinc Chloride) for 3 weeks. | Other: Experimental Dentifrice<br>* Dentifrice containing 0.454% stannous fluoride with 0.3% zinc chloride.<br>|
| Active Comparator: Reference Dentifrice<br>Participants will be instructed to brush twice daily (for 1 minute, morning and evening) with the reference dentifrice (Regular Fluoride Dentifrice) for 3 weeks. | Other: Reference Dentifrice<br>* Standard fluoride dentifrice containing 0.243% sodium fluoride.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Organoleptic Score from Baseline (Day 0, Pre-Brushing) to 3 Weeks (Pre-Brushing) | An organoleptic assessment is used to evaluate the oral odor and is defined as a method that can measure the strength of target odors and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The scale measures from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline will be calculated as mean score at 3 weeks (pre-brushing) minus mean score at Baseline (Day 0, pre-brushing). | Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (Pre-Brushing) in Mean Total Volatile Sulfur Compounds (VSCs) Concentration in Breath | The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in parts per billion [ppb]) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately, and the total VSCs concentration will be calculated as the sum of the 3 individual concentrations. The change from Baseline will be calculated as mean value at 3 weeks (pre-brushing) minus mean value at Baseline (Day 0, pre-brushing). | Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing) | 
| Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (Pre-Brushing) in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean value at 3 weeks (pre-brushing) minus mean value at Baseline (Day 0, pre-brushing). | Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing) | 
| Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (1 hour Post-Brushing) in Mean total VSC Concentration in Breath | The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately, and the total VSCs concentration will be calculated as the sum of the 3 individual concentrations. The change from Baseline will be calculated as mean value at 3 weeks (1 hour post-brushing) minus mean value at Baseline (Day 0, pre-brushing). | Baseline (Day 0, Pre-Brushing) and Week 3 (1 hour Post-Brushing) | 
| Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (1 hour Post-Brushing) in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean value at 3 weeks (1 hour post-brushing) minus mean value at Baseline (Day 0, pre-brushing). | Baseline (Day 0, Pre-Brushing) and Week 3 (1 hour Post-Brushing) | 
| Change from Baseline (Day 0, Pre-Brushing) to 3 Weeks (1 hour Post-Brushing) in Mean Breath Organoleptic Scores | An organoleptic assessment is used to evaluate the oral odor and is defined as a method that can measure the strength of target odors and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The scale measures from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline will be calculated as mean score at 3 weeks (1 Hour Post-Brushing) minus mean score at Baseline (Day 0, pre-brushing). | Baseline (Day 0, Pre-Brushing) and Week 3 (1 hour Post-Brushing) | 
| Change from Baseline (Day 0, Pre-Brushing) to 1 Hour Post-Brushing in Mean Total VSC Concentration in Breath | The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately, and the total VSCs concentration will be calculated as the sum of the 3 individual concentrations. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Day 0. | Baseline (Day 0, Pre-Brushing) and Hour 1 (Post-Brushing) | 
| Change from Baseline (Day 0, Pre-Brushing) to 1 Hour Post-Brushing in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Day 0. | Baseline (Day 0, Pre-Brushing) and Hour 1 (Post-Brushing) | 
| Change from Baseline (Day 0, Pre-Brushing) to 1 Hour Post-Brushing in Mean Breath Organoleptic Scores | An organoleptic assessment is used to evaluate the oral odor and is defined as a method that can measure the strength of target odors and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The scale measures from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. Lower score indicates improvement. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Day 0. | Baseline (Day 0, Pre-Brushing) and Hour 1 (Post-Brushing) | 
| Change from Baseline (3 Weeks, Pre-Brushing) to 1 Hour Post-Brushing in Mean Total VSC Concentration in Breath | The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately, and the total VSCs concentration will be calculated as the sum of the 3 individual concentrations. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Week 3. | Baseline (3 Weeks, Pre-Brushing) and Hour 1 (Post-Brushing) | 
| Change from Baseline (3 Weeks, Pre-Brushing) to 1 Hour Post-Brushing in Mean Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath | The VSCs concentration in breath sample will be evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe will be used to obtain a sample of the mouth air of the participant. The OralChroma is a portable gas chromatograph with a highly sensitive semiconductor gas detector which can determine the concentration of the three main VSCs in breath (hydrogen sulfide, methane thiol and dimethyl sulfide). The concentration values (in ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide will be recorded separately. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Week 3. | Baseline (3 Weeks, Pre-Brushing) and Hour 1 (Post-Brushing) | 
| Change from Baseline (3 Weeks, Pre-Brushing) to 1 Hour Post-Brushing in Mean Breath Organoleptic Scores | An organoleptic assessment is used to evaluate the oral odor and is defined as a method that can measure the strength of target odors and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The scale measures from 0 (lowest score) to 5 (highest score), where 0= No appreciable odor, 1= Barely noticeable odor, 2= Slight but clearly noticeable odor, 3= Moderate odor, 4= Strong odor, 5= Extremely foul odor. The change from Baseline will be calculated as mean score at 1 hour post-brushing minus mean score at pre-brushing on Week 3. | Baseline (3 Weeks, Pre-Brushing) and Hour 1 (Post-Brushing) |