Trial Outcomes & Findings for 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 (NCT NCT05524948)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

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

Results posted on

2024-08-26

Participant Flow

All participants were recruited at a single center in United States of America (USA).

A total of 104 participants were screened, enrolled and randomized (52 participants to the experimental dentifrice group and 52 participants to the reference dentifrice group) in the study, of which 101 participants completed the study.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	52	52
Overall Study COMPLETED	50	51
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	1	0
Overall Study Participant did not receive call or showed up for final visit	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Dentifrice n=52 Participants 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.	Reference Dentifrice n=52 Participants 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.	Total n=104 Participants Total of all reporting groups
Age, Continuous	48.5 years STANDARD_DEVIATION 10.91 • n=5 Participants	46.4 years STANDARD_DEVIATION 11.17 • n=7 Participants	47.4 years STANDARD_DEVIATION 11.04 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	38 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	51 Participants n=7 Participants	99 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	43 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=50 Participants 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.	Reference Dentifrice n=51 Participants 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.
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Breath Organoleptic Scores	-1.23 Score on a scale Standard Error 0.146	0.07 Score on a scale Standard Error 0.145

SECONDARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=50 Participants 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.	Reference Dentifrice n=51 Participants 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.
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Total Volatile Sulfur Compounds (VSCs) Concentration in Breath	-518.00 Parts per billion Standard Error 68.469	51.64 Parts per billion Standard Error 67.779

SECONDARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=50 Participants 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.	Reference Dentifrice n=51 Participants 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.
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath Hydrogen Sulfide	-348.60 Parts per billion Standard Error 45.553	70.26 Parts per billion Standard Error 45.093
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath Methanethiol	-118.88 Parts per billion Standard Error 23.040	-9.97 Parts per billion Standard Error 22.810
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Hydrogen Sulfide, Methanethiol and Dimethyl Sulfide Concentration in Breath Dimethyl Sulfide	-42.59 Parts per billion Standard Error 16.234	-16.42 Parts per billion Standard Error 16.074

SECONDARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=50 Participants 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.	Reference Dentifrice n=51 Participants 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.
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath	-733.17 Parts per billion Standard Error 66.436	-11.59 Parts per billion Standard Error 65.766

SECONDARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=50 Participants 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.	Reference Dentifrice n=51 Participants 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.
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 Hydrogen Sulfide	-507.84 Parts per billion Standard Error 47.830	60.05 Parts per billion Standard Error 47.348
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 Methanethiol	-176.69 Parts per billion Standard Error 17.351	-71.30 Parts per billion Standard Error 17.178
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 Dimethyl Sulfide	-43.45 Parts per billion Standard Error 18.568	-5.42 Parts per billion Standard Error 18.384

SECONDARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=50 Participants 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.	Reference Dentifrice n=51 Participants 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.
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores	-2.55 Score on a scale Standard Error 0.145	-0.38 Score on a scale Standard Error 0.143

SECONDARY outcome

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

Population: mITT population.

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).

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=52 Participants 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.	Reference Dentifrice n=52 Participants 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.
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Total VSC Concentration in Breath	-434.60 Parts per billion Standard Error 67.213	-37.64 Parts per billion Standard Error 67.213

SECONDARY outcome

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

Population: mITT population.

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).

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=52 Participants 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.	Reference Dentifrice n=52 Participants 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.
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 Hydrogen Sulfide	-324.07 Parts per billion Standard Error 50.984	17.30 Parts per billion Standard Error 50.984
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 Methanethiol	-137.61 Parts per billion Standard Error 14.737	-63.46 Parts per billion Standard Error 14.737
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 Dimethyl Sulfide	31.79 Parts per billion Standard Error 18.313	3.81 Parts per billion Standard Error 18.313

SECONDARY outcome

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

Population: mITT population.

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).

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=52 Participants 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.	Reference Dentifrice n=52 Participants 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.
Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Breath Organoleptic Scores	-2.11 Score on a scale Standard Error 0.098	-0.56 Score on a scale Standard Error 0.098

SECONDARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=50 Participants 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.	Reference Dentifrice n=51 Participants 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.
Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath	-301.42 Parts per billion Standard Error 47.053	21.33 Parts per billion Standard Error 46.567

SECONDARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=50 Participants 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.	Reference Dentifrice n=51 Participants 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.
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 Hydrogen Sulfide	-210.39 Parts per billion Standard Error 29.608	39.94 Parts per billion Standard Error 29.300
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 Methanethiol	-82.58 Parts per billion Standard Error 16.472	-37.05 Parts per billion Standard Error 16.307
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 Dimethyl Sulfide	-11.38 Parts per billion Standard Error 18.470	21.31 Parts per billion Standard Error 18.287

SECONDARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=50 Participants 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.	Reference Dentifrice n=51 Participants 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.
Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores	-1.49 Score on a scale Standard Error 0.108	-0.29 Score on a scale Standard Error 0.107

Adverse Events

Experimental Dentifrice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference Dentifrice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Haleon Response Center

HALEON

Phone: +447880182593

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER