Four-Week Oral Malodor and Clinical Safety for a Concentrated Cosmetic Mouthwash
NCT Number: NCT06479096
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Oral Malodor
Interventions: OTHER: Brush / Espresso Mild Prototype|OTHER: Brush / Espresso Intense Prototype|OTHER: Brush / Fresh Breath Oral Rinse|OTHER: Brush / Hydroalcohol
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 168
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2024-09-13
Locations: Salus Research, Inc., Fort Wayne, Indiana, 46825, United States

Summary:
The objective of this study is to evaluate the safety of the concentrated mouthwash prototypes, and to evaluate the efficacy of the concentrated mouthwash prototypes in the control of oral malodor compared to a comparator mouthwash and a negative control.

Primary Outcome Measures: Mean malodor intensity assessed at 60 minutes after product use, Mean malodor intensity will be independently assessed by three odor trained judges 60 minutes after product use on Day 0 using the following scale: 0 = No appreciable odor, 1 = Barely noticeable odor, 2 = Slight but clearly noticeable odor, 3 = Moderate odor, 4 = Strong odor, 5 = Extremely foul odor, After 60 minutes of product use|Mean malodor intensity assessed at 120 minutes after product use, Mean malodor intensity will be independently assessed by three odor trained judges 120 minutes after product use on Day 0 using the following scale: 0 = No appreciable odor, 1 = Barely noticeable odor, 2 = Slight but clearly noticeable odor, 3 = Moderate odor, 4 = Strong odor, 5 = Extremely foul odor, After 120 minutes of product use|Mean malodor intensity assessed at 180 minutes after product use, Mean malodor intensity will be independently assessed by three odor trained judges 180 minutes after product use on Day 0 using the following scale: 0 = No appreciable odor, 1 = Barely noticeable odor, 2 = Slight but clearly noticeable odor, 3 = Moderate odor, 4 = Strong odor, 5 = Extremely foul odor, After 180 minutes of product use|Mean malodor intensity assessed at 240 minutes after product use, Mean malodor intensity will be independently assessed by three odor trained judges 240 minutes after product use on Day 0 using the following scale: 0 = No appreciable odor, 1 = Barely noticeable odor, 2 = Slight but clearly noticeable odor, 3 = Moderate odor, 4 = Strong odor, 5 = Extremely foul odor, After 240 minutes of product use|Mean malodor intensity assessed at 12 hours after product use on Day 7, Mean malodor intensity will be independently assessed by three odor trained judges 12 hours after product use on Day 7 using the following scale: 0 = No appreciable odor, 1 = Barely noticeable odor, 2 = Slight but clearly noticeable odor, 3 = Moderate odor, 4 = Strong odor, 5 = Extremely foul odor, After 12 hours of product use on Day 7|Mean malodor intensity assessed at 12 hours after product use on Day 21, Mean malodor intensity will be independently assessed by three odor trained judges 12 hours after product use on Day 21 using the following scale: 0 = No appreciable odor, 1 = Barely noticeable odor, 2 = Slight but clearly noticeable odor, 3 = Moderate odor, 4 = Strong odor, 5 = Extremely foul odor, After 12 hours of product use on Day 21
Secondary Outcome Measures: Total volatile sulfur compounds (VSC) concentration assessed at 60 minutes after product use on Day 0, Two mouth air sample will be evaluated 60 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the total VSC concentration in breath (hydrogen sulfide, methyl mercaptan, and methyl sulfide) in the range of 50- 2400ppb., After 60 minutes of product use|Total volatile sulfur compounds (VSC) concentration assessed at 120 minutes after product use on Day 0, Two mouth air sample will be evaluated 120 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the total VSC concentration in breath (hydrogen sulfide, methyl mercaptan, and methyl sulfide) in the range of 50- 2400ppb., After 120 minutes of product use|Total volatile sulfur compounds (VSC) concentration assessed at 180 minutes after product use on Day 0, Two mouth air sample will be evaluated 180 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the total VSC concentration in breath (hydrogen sulfide, methyl mercaptan, and methyl sulfide) in the range of 50- 2400ppb., After 180 minutes of product use|Total volatile sulfur compounds (VSC) concentration assessed at 240 minutes after product use on Day 0, Two mouth air sample will be evaluated 240 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the total VSC concentration in breath (hydrogen sulfide, methyl mercaptan, and methyl sulfide) in the range of 50- 2400ppb., After 240 minutes of product use|Total volatile sulfur compounds (VSC) concentration assessed at 12 hours after product use on Day 7, Two mouth air sample will be evaluated 12 hours after product use on Day 7 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the total VSC concentration in breath (hydrogen sulfide, methyl mercaptan, and methyl sulfide) in the range of 50- 2400ppb., After 12 hours of product use on Day 7|Total volatile sulfur compounds (VSC) concentration assessed at 12 hours after product use on Day 21, Two mouth air sample will be evaluated 12 hours after product use on Day 21 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the total VSC concentration in breath (hydrogen sulfide, methyl mercaptan, and methyl sulfide) in the range of 50- 2400ppb., After 12 hours of product use on Day 21|Hydrogen sulfide concentration assessed at 60 minutes after product use on Day 0, Two mouth air sample will be evaluated 60 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the hydrogen sulfide concentration in the breath in the range of 50- 2400ppb., After 60 minutes of product use on Day 0|Hydrogen sulfide concentration assessed at 120 minutes after product use on Day 0, Two mouth air sample will be evaluated 120 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the hydrogen sulfide concentration in the breath in the range of 50- 2400ppb., After 120 minutes of product use on Day 0|Hydrogen sulfide concentration assessed at 180 minutes after product use on Day 0, Two mouth air sample will be evaluated 180 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the hydrogen sulfide concentration in the breath in the range of 50- 2400ppb., After 180 minutes of product use on Day 0|Hydrogen sulfide concentration assessed at 240 minutes after product use on Day 0, Two mouth air sample will be evaluated 240 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the hydrogen sulfide concentration in the breath in the range of 50- 2400ppb., After 240 minutes of product use on Day 0|Hydrogen sulfide concentration assessed at 12 hours after product use on Day 7, Two mouth air sample will be evaluated 12 hours after product use on Day 7 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the hydrogen sulfide concentration in the breath in the range of 50- 2400ppb., After 12 hours of product use on Day 7|Hydrogen sulfide concentration assessed at 12 hours after product use on Day 21, Two mouth air sample will be evaluated 12 hours after product use on Day 21 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the hydrogen sulfide concentration in the breath in the range of 50- 2400ppb., After 12 hours of product use on Day 21|Methyl mercaptan concentration assessed at 60 minutes after product use on Day 0, Two mouth air sample will be evaluated 60 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 60 minutes of product use on Day 0|Methyl mercaptan concentration assessed at 120 minutes after product use on Day 0, Two mouth air sample will be evaluated 120 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 120 minutes of product use on Day 0|Methyl mercaptan concentration assessed at 180 minutes after product use on Day 0, Two mouth air sample will be evaluated 180 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 180 minutes of product use on Day 0|Methyl mercaptan concentration assessed at 240 minutes after product use on Day 0, Two mouth air sample will be evaluated 240 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 240 minutes of product use on Day 0|Methyl mercaptan concentration assessed at 12 hours after product use on Day 7, Two mouth air sample will be evaluated 12 hours after product use on Day 7 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 12 hours of product use on Day 7|Methyl mercaptan concentration assessed at 12 hours after product use on Day 21, Two mouth air sample will be evaluated 12 hours after product use on Day 21 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 12 hours of product use on Day 21|Methyl sulfide concentration assessed at 60 minutes after product use on Day 0, Two mouth air sample will be evaluated 60 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 60 minutes of product use on Day 0|Methyl sulfide concentration assessed at 120 minutes after product use on Day 0, Two mouth air sample will be evaluated 120 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 120 minutes of product use on Day 0|Methyl sulfide concentration assessed at 180 minutes after product use on Day 0, Two mouth air sample will be evaluated 180 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 180 minutes of product use on Day 0|Methyl sulfide concentration assessed at 240 minutes after product use on Day 0, Two mouth air sample will be evaluated 240 minutes after product use on Day 0 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 240 minutes of product use on Day 0|Methyl sulfide concentration assessed at 12 hours after product use on Day 7, Two mouth air sample will be evaluated 12 hours after product use on Day 7 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 12 hours of product use on Day 7|Methyl sulfide concentration assessed at 12 hours after product use on Day 21, Two mouth air sample will be evaluated 12 hours after product use on Day 21 using the Oral Chroma Halitosis Measuring instrument, a portable gas chromatograph with a highly sensitive semiconductor gas detector that will determine the methyl mercaptan concentration in the breath in the range of 50- 2400ppb., After 12 hours of product use on Day 21