An interventional study of Experimental Dentifrice and Reference Dentifrice in Halitosis, sponsored by HALEON. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by HALEON · Not applicable, Interventional, and Treatment
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.
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.
93 studies on the registry are indexed under Halitosis; 17 are open to participants now.
This study's enrollment of 104 is above the median of 45 across 79 interventional studies indexed under Halitosis.
Browse Halitosis studies →HALEON is the lead sponsor of 64 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant with generally good oral health that fulfil all of the following:
Exclusion Criteria:
General medical exclusions:
General medication exclusions:
General oral exclusions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Dentifrice containing 0.454% stannous fluoride with 0.3% zinc chloride.
Standard fluoride dentifrice containing 0.243% sodium fluoride.
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.
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
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).
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
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).
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (Pre-Brushing)
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).
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
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).
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
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).
Time frame: Baseline (Day 0, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
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).
Time frame: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
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).
Time frame: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
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).
Time frame: Baseline (Day 0, Pre-Brushing) and Day 0 (1 Hour Post-Brushing)
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).
Time frame: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
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).
Time frame: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
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).
Time frame: Baseline (Week 3, Pre-Brushing) and Week 3 (1 Hour Post-Brushing)
All participants were recruited at a single center in United States of America (USA).
| Milestone | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Started | 52 | 52 |
| Completed | 50 | 51 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Participant did not receive call or showed up for final visit | 1 | 1 |
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.
| Score on a scale | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (Pre-Brushing) in Breath Organoleptic Scores | -1.23 ± 0.146 | 0.07 ± 0.145 |
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).
| Parts per billion | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| 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 ± 68.469 | 51.64 ± 67.779 |
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).
| Parts per billion | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Hydrogen Sulfide | -348.60 ± 45.553 | 70.26 ± 45.093 |
| Methanethiol | -118.88 ± 23.040 | -9.97 ± 22.810 |
| Dimethyl Sulfide | -42.59 ± 16.234 | -16.42 ± 16.074 |
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).
| Parts per billion | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | -733.17 ± 66.436 | -11.59 ± 65.766 |
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).
| Parts per billion | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Hydrogen Sulfide | -507.84 ± 47.830 | 60.05 ± 47.348 |
| Methanethiol | -176.69 ± 17.351 | -71.30 ± 17.178 |
| Dimethyl Sulfide | -43.45 ± 18.568 | -5.42 ± 18.384 |
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).
| Score on a scale | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores | -2.55 ± 0.145 | -0.38 ± 0.143 |
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).
| Parts per billion | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | -434.60 ± 67.213 | -37.64 ± 67.213 |
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).
| Parts per billion | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Hydrogen Sulfide | -324.07 ± 50.984 | 17.30 ± 50.984 |
| Methanethiol | -137.61 ± 14.737 | -63.46 ± 14.737 |
| Dimethyl Sulfide | 31.79 ± 18.313 | 3.81 ± 18.313 |
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).
| Score on a scale | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Adjusted Mean Change From Baseline (Day 0, Pre-Brushing) to Day 0 (1 Hour Post-Brushing) in Breath Organoleptic Scores | -2.11 ± 0.098 | -0.56 ± 0.098 |
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).
| Parts per billion | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Total VSC Concentration in Breath | -301.42 ± 47.053 | 21.33 ± 46.567 |
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).
| Parts per billion | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Hydrogen Sulfide | -210.39 ± 29.608 | 39.94 ± 29.300 |
| Methanethiol | -82.58 ± 16.472 | -37.05 ± 16.307 |
| Dimethyl Sulfide | -11.38 ± 18.470 | 21.31 ± 18.287 |
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).
| Score on a scale | Experimental Dentifrice | Reference Dentifrice |
|---|---|---|
| Adjusted Mean Change From Baseline (Week 3, Pre-Brushing) to Week 3 (1 Hour Post-Brushing) in Breath Organoleptic Scores | -1.49 ± 0.108 | -0.29 ± 0.107 |
Collected over All-cause mortality, Serious Adverse Events (SAEs), Non-SAEs and Medical Device incidents were collected immediately after signing of informed consent until 5 days following last administration of the study product (Visit 3, Week 3) (Collected up to 35 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Dentifrice | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Reference Dentifrice | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
Modified Intent-To-Treat (mITT) population included all randomized participants who completed at least one use of study product and had at least one post treatment efficacy assessment.
| Age, Continuous(years) | Experimental Dentifrice | Reference Dentifrice | Total |
|---|---|---|---|
| Mean | 48.5 ± 10.91 | 46.4 ± 11.17 | 47.4 ± 11.04 |
| Sex: Female, Male(Participants) | Experimental Dentifrice | Reference Dentifrice | Total |
|---|---|---|---|
| Female | 38 | 38 | 76 |
| Male | 14 | 14 | 28 |
| Ethnicity (NIH/OMB)(Participants) | Experimental Dentifrice | Reference Dentifrice | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 1 | 5 |
| Not Hispanic or Latino | 48 | 51 | 99 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Experimental Dentifrice | Reference Dentifrice | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 8 | 19 |
| White | 37 | 43 | 80 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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