A Clinical Study to Examine the Effects of an Experimenta... | NCT05524948

Label	Type	Description	Intervention Names
Experimental Dentifrice	Experimental	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
Reference Dentifrice	Active Comparator	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

Name	Type	Description	Arm Group Labels	Other Names
Experimental Dentifrice	Other	Dentifrice containing 0.454% stannous fluoride with 0.3% zinc chloride.	Experimental Dentifrice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Breath Organoleptic Scores	An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored 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 was calculated as score at Week 3 (Pre-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). Analysis was performed using Analysis of Covariance (ANCOVA) method.	Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)

Secondary Outcomes

Measure	Description	Time Frame
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Total Volatile Sulfur Compounds (VSCs) Concentration in Breath	The VSCs concentration in breath sample was evaluated using OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (in parts per billion [ppb]) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (Pre-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).

Eligibility Module

Eligibility Criteria

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:
1. Having at least 20 natural (vital) teeth.
2. Good oral health without lesions in the oral cavity (including the tongue) that could interfere with the study evaluations.
3. Having clinically diagnosed, plaque-induced gingivitis defined as having 10-30% bleeding sites from the bleeding on probing assessment.
4. 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).
5. 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:
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.

Facility	Status	City	State	ZIP	Country	Contacts
Salus Research Inc.		Fort Wayne	Indiana	46825	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454 percentage [%] stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 17, 2022	Aug 14, 2023

Arm/Group Information

ID	Title	Description
BG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.
BG001	Reference Dentifrice	In this arm, eligible participants applied a ribbon of reference dentifrice (0.243% sodium fluoride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with reference dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the reference dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00052 BG00152 BG002104

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Breath Organoleptic Scores

An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored 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 was calculated as score at Week 3 (Pre-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing). Analysis was performed using Analysis of Covariance (ANCOVA) method.

mlTT population. Only those participants available at the indicated timepoints were analyzed.

Posted

Mean

Standard Error

Score on a scale

Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.
OG001	Reference Dentifrice	In this arm, eligible participants applied a ribbon of reference dentifrice (0.243% sodium fluoride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with reference dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the reference dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Units	Counts
Participants	OG00050 OG00151

Title

Denominators

Categories

Title	Measurements
	OG000-1.23± 0.146 OG0010.07± 0.145

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.	<0.0001		Adjusted Mean Difference	-1.30	Standard Error of the Mean	0.206	2-Sided	95	-1.71	-0.90			Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.		Other

Secondary

Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Total Volatile Sulfur Compounds (VSCs) Concentration in Breath

The VSCs concentration in breath sample was evaluated using OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (in parts per billion [ppb]) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (Pre-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).

mlTT population. Only those participants available at the indicated timepoints were analyzed.

Posted

Mean

Standard Error

Parts per billion

Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Secondary

Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (Pre-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).

mlTT population. Only those participants available at the indicated timepoints were analyzed.

Posted

Mean

Standard Error

Parts per billion

Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Secondary

Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath

The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).

mlTT population. Only those participants available at the indicated timepoints were analyzed.

Posted

Mean

Standard Error

Parts per billion

Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Secondary

Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post--Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).

mlTT population. Only those participants available at the indicated timepoints were analyzed.

Posted

Mean

Standard Error

Parts per billion

Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Secondary

Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores

An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored 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 was calculated as score at Week 3 (1 Hour Post-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).

mlTT population. Only those participants available at the indicated timepoints were analyzed.

Posted

Mean

Standard Error

Score on a scale

Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Secondary

Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Total VSC Concentration in Breath

The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Day 0 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).

mITT population.

Posted

Mean

Standard Error

Parts per billion

Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Secondary

Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Day 0 (1 Hour Post-Brushing) minus value at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).

mITT population.

Posted

Mean

Standard Error

Parts per billion

Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Secondary

Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Breath Organoleptic Scores

An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored 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 was calculated as score at Day 0 (1 Hour Post-Brushing) minus score at Baseline (Day 0, Pre-Brushing). Baseline was defined as Day 0 (Pre-Brushing).

mITT population.

Posted

Mean

Standard Error

Score on a scale

Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Secondary

Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath

The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately, and the adjusted mean of total VSCs concentration was reported. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing).

mlTT population. Only those participants available at the indicated timepoints were analyzed.

Posted

Mean

Standard Error

Parts per billion

Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Secondary

Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath

The VSCs concentration in breath sample was evaluated using the OralChroma Halitosis Measuring instrument. A clean and sterile OralChroma syringe was 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, methanethiol and dimethyl sulfide). The concentration values (ppb) of hydrogen sulfide, methanethiol and dimethyl sulfide were recorded separately. The change from Baseline was calculated as value at Week 3 (1 Hour Post-Brushing) minus value at Baseline (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing).

mlTT population. Only those participants available at the indicated timepoints were analyzed.

Posted

Mean

Standard Error

Parts per billion

Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Secondary

Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores

An organoleptic assessment was used to evaluate the oral odor and defined as a method that measures the strength of target odor and expresses the value in terms of a score with reference to a pre-defined organoleptic scale. The assessors evaluated the oral odor and scored 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 was calculated as score at Week 3 (1 Hour Post-Brushing) minus score at (Week 3, Pre-Brushing). Baseline was defined as Week 3 (Pre-Brushing).

mlTT population. Only those participants available at the indicated timepoints were analyzed.

Posted

Mean

Standard Error

Score on a scale

Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)

ID	Title	Description
OG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Experimental Dentifrice	In this arm, eligible participants applied a ribbon of experimental dentifrice (0.454% stannous fluoride with 0.3% zinc chloride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with experimental dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the experimental dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.	0	52	0	52	0	52
EG001	Reference Dentifrice	In this arm, eligible participants applied a ribbon of reference dentifrice (0.243% sodium fluoride) to the toothbrush head and brushed their teeth under supervision for one timed minute on Visit 2 (1 to 3 weeks after screening). One hour (+/-5 minutes) post-brushing, participants had their post-brushing assessments and were instructed to brush twice daily (for 1 minute, morning and evening) with reference dentifrice for the next 3 weeks until their next visit (Visit 3). At Visit 3 (Week 3), participants received the reference dentifrice and underwent pre-brushing and post-brushing assessments in the same manner as performed at the Visit 2.	0	52	0	52	0	52

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms