Oral MalodorNCT06479096
Four-Week Oral Malodor and Clinical Safety for a Concentrated Cosmetic Mouthwash
A study testing Brush / Espresso Mild Prototype, Brush / Espresso Intense Prototype and Brush / Fresh Breath Oral Rinse in people with Oral Malodor, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Malodor
- What is being tested?
- Brush / Espresso Mild Prototype, Brush / Espresso Intense Prototype and Brush / Fresh Breath Oral Rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to comprehend and follow the requirements and restrictions of the clinical trial (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical trial) based upon research site personnel's assessment;
- Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial;
- Able to read and understand the local language (subject is capable of reading the documents);
- Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);
- Adults, 18 years of age and older, in good general and oral health without any known allergy to commercial dental products or cosmetics;
- Negative pregnancy urine tests (females of child-bearing potential only);
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- For females: Postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study IP administration) or premenopausal/perimenopausal state with an effective means of contraception.
- For males: No pregnant or lactating spouse or partner at screening and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the study and for 30 days thereafter.
- Females of childbearing potential must be using a medically acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the clinical trial. Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include:
- Double barrier method (condoms, diaphragm or cervical cap with spermicide),
- Hormonal prescription contraceptives (i.e., oral, injectable, implanted, patch or vaginal ring hormone therapy)
- Intrauterine device (IUD)
- Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal ligation, hysterectomy and/or bilateral oophorectomy)
- Abstinence
- A minimum of 16 uncrowned teeth;
- At Screening (Visit 1) and before brushing with the assigned study product at Baseline (Visit 2), subjects must provide 2 samples of mouth air, which must have a mean hydrogen sulfide concentration greater than 200ppb. At screening and baseline (pre-brushing), the two samples of mouth air must have a ≤ 500ppb difference in hydrogen sulfide values;
- At Baseline (Visit 2), before brushing with assigned dentifrice, subjects must provide a breath sample with a mean organoleptic score ≥3.5 across judges;
- Absence of significant oral soft tissue pathology, periodontitis and active dental caries, based on a visual examination and at the discretion of the Investigator; and
- Absence of partial dentures, dentures, orthodontic bands, fixed retainers, removable orthodontic appliances.
Who cannot join
- Diagnosed with Xerostomia;
- Suspected alcohol or substance abuse at the discretion of the Investigator (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
- Known sensitivity, allergy or contraindications to any investigational product ingredient, oral care products and auxiliary supplies provided for the study;
- Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e-cigarette usage;
- Females who are pregnant, planning to become pregnant or breastfeeding during the study;
- Subjects who were previously screened and determined to be ineligible for the study (unless subject previously screen failed for the OralChroma GC and/or organoleptic criteria;
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- Participation in any clinical study investigation within 30 days of Screening visit (Visit 1);
- Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
- Has a compromised immune system;
- Has any acute or chronic, medical or psychiatric conditions) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the medically qualified investigator, would make the subject inappropriate for entry in this study;
- Significant, unstable or uncontrolled medical condition which may interfere with subject's participation in the study, at the discretion of the Investigator; and
- Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal Investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson (J\&J) subsidiaries, contractors of J\&J, and the families of each).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Oral Malodor
- Being tested
- Brush / Espresso Mild Prototype, Brush / Espresso Intense Prototype, Brush / Fresh Breath Oral Rinse, Brush / Hydroalcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brush / Espresso Mild PrototypeOther
Subjects will brush and rinse with their assigned mouthwash twice daily.
Brush / Espresso Intense PrototypeOther
Subjects will brush and rinse with their assigned mouthwash twice daily.
Brush / Fresh Breath Oral RinseOther
Subjects will brush and rinse with their assigned mouthwash twice daily.
Brush / HydroalcoholOther
Subjects will brush and rinse with their assigned mouthwash twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Brush / Espresso Mild Prototype | Experimental | All subjects will receive a marketed fluoride-containing dentifrice and a soft flat trimmed bristled toothbrush to use for the one week wash out period and throughout the study. Subjects will be required to record their daily product use times on a subject diary. After the one week wash out period, subjects subjects will use their assigned mouthwash for the first time at the site under supervision. Subjects will brush their teeth at the site after all assessments are complete. That evening, subjects will brush their teeth and rinse a second time unsupervised. All other twice daily brushing/rinsing will occur unsupervised at home. Subjects will be required to record their daily product use times (brushing and rinsing) on their subject diary. Receives: Other: Brush / Espresso Mild Prototype |
| Brush / Espresso Intense Prototype | Experimental | All subjects will receive a marketed fluoride-containing dentifrice and a soft flat trimmed bristled toothbrush to use for the one week wash out period and throughout the study. Subjects will be required to record their daily product use times on a subject diary. After the one week wash out period, subjects subjects will use their assigned mouthwash for the first time at the site under supervision. Subjects will brush their teeth at the site after all assessments are complete. That evening, subjects will brush their teeth and rinse a second time unsupervised. All other twice daily brushing/rinsing will occur unsupervised at home. Subjects will be required to record their daily product use times (brushing and rinsing) on their subject diary. Receives: Other: Brush / Espresso Intense Prototype |
| Brush / Fresh Breath Oral Rinse | Active comparator | All subjects will receive a marketed fluoride-containing dentifrice and a soft flat trimmed bristled toothbrush to use for the one week wash out period and throughout the study. Subjects will be required to record their daily product use times on a subject diary. After the one week wash out period, subjects subjects will use their assigned mouthwash for the first time at the site under supervision. Subjects will brush their teeth at the site after all assessments are complete. That evening, subjects will brush their teeth and rinse a second time unsupervised. All other twice daily brushing/rinsing will occur unsupervised at home. Subjects will be required to record their daily product use times (brushing and rinsing) on their subject diary. Receives: Other: Brush / Fresh Breath Oral Rinse |
| Brush / Hydroalcohol | Placebo comparator | All subjects will receive a marketed fluoride-containing dentifrice and a soft flat trimmed bristled toothbrush to use for the one week wash out period and throughout the study. Subjects will be required to record their daily product use times on a subject diary. After the one week wash out period, subjects subjects will use their assigned mouthwash for the first time at the site under supervision. Subjects will brush their teeth at the site after all assessments are complete. That evening, subjects will brush their teeth and rinse a second time unsupervised. All other twice daily brushing/rinsing will occur unsupervised at home. Subjects will be required to record their daily product use times (brushing and rinsing) on their subject diary. Receives: Other: Brush / Hydroalcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: After 12 hours of product use on Day 21
Secondary outcomes (24)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 12 hours of product use on Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start15 Jul 2024
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MalodorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Milleman, DDS, Principal investigator, Salus Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479096
- Sponsor's protocol ID
- CS2024OC100108
- Status last verified
- Aug 2024
- First submitted
- 24 Jun 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four-Week Oral Malodor and Clinical Safety for a Concentrated Cosmetic Mouthwash
- ClinicalTrials.gov ID
- NCT06479096
- Acronym / sponsor ID
- CS2024OC100108
- Conditions
- Oral Malodor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Brush / Espresso Mild Prototype | Experimental | Other: Brush / Espresso Mild PrototypeAll subjects will receive a marketed fluoride-containing dentifrice and a soft flat trimmed bristled toothbrush to use for the one week wash out period and throughout the study. Subjects will be required to record their daily product use times on a subject diary. After the one week wash out period, subjects subjects will use their assigned mouthwash for the first time at the site under supervision. Subjects will brush their teeth at the site after all assessments are complete. That evening, subjects will brush their teeth and rinse a second time unsupervised. All other twice daily brushing/rinsing will occur unsupervised at home. Subjects will be required to record their daily product use times (brushing and rinsing) on their subject diary. |
| Brush / Espresso Intense Prototype | Experimental | Other: Brush / Espresso Intense PrototypeAll subjects will receive a marketed fluoride-containing dentifrice and a soft flat trimmed bristled toothbrush to use for the one week wash out period and throughout the study. Subjects will be required to record their daily product use times on a subject diary. After the one week wash out period, subjects subjects will use their assigned mouthwash for the first time at the site under supervision. Subjects will brush their teeth at the site after all assessments are complete. That evening, subjects will brush their teeth and rinse a second time unsupervised. All other twice daily brushing/rinsing will occur unsupervised at home. Subjects will be required to record their daily product use times (brushing and rinsing) on their subject diary. |
| Brush / Fresh Breath Oral Rinse | Active comparator | Other: Brush / Fresh Breath Oral RinseAll subjects will receive a marketed fluoride-containing dentifrice and a soft flat trimmed bristled toothbrush to use for the one week wash out period and throughout the study. Subjects will be required to record their daily product use times on a subject diary. After the one week wash out period, subjects subjects will use their assigned mouthwash for the first time at the site under supervision. Subjects will brush their teeth at the site after all assessments are complete. That evening, subjects will brush their teeth and rinse a second time unsupervised. All other twice daily brushing/rinsing will occur unsupervised at home. Subjects will be required to record their daily product use times (brushing and rinsing) on their subject diary. |
| Brush / Hydroalcohol | Placebo comparator | Other: Brush / HydroalcoholAll subjects will receive a marketed fluoride-containing dentifrice and a soft flat trimmed bristled toothbrush to use for the one week wash out period and throughout the study. Subjects will be required to record their daily product use times on a subject diary. After the one week wash out period, subjects subjects will use their assigned mouthwash for the first time at the site under supervision. Subjects will brush their teeth at the site after all assessments are complete. That evening, subjects will brush their teeth and rinse a second time unsupervised. All other twice daily brushing/rinsing will occur unsupervised at home. Subjects will be required to record their daily product use times (brushing and rinsing) on their subject diary. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Able to comprehend and follow the requirements and restrictions of the clinical trial (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical trial) based upon research site personnel's assessment;
- Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial;
- Able to read and understand the local language (subject is capable of reading the documents);
- Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);
- Adults, 18 years of age and older, in good general and oral health without any known allergy to commercial dental products or cosmetics;
Key exclusion criteria (12 listed)
- Diagnosed with Xerostomia;
- Suspected alcohol or substance abuse at the discretion of the Investigator (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
- Known sensitivity, allergy or contraindications to any investigational product ingredient, oral care products and auxiliary supplies provided for the study;
- Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e-cigarette usage;
- Females who are pregnant, planning to become pregnant or breastfeeding during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brush / Espresso Mild PrototypeSubjects will brush and rinse with their assigned mouthwash twice daily. | Other | Brush / Espresso Mild Prototype |
| Brush / Espresso Intense PrototypeSubjects will brush and rinse with their assigned mouthwash twice daily. | Other | Brush / Espresso Intense Prototype |
| Brush / Fresh Breath Oral RinseSubjects will brush and rinse with their assigned mouthwash twice daily. | Other | Brush / Fresh Breath Oral Rinse |
| Brush / HydroalcoholSubjects will brush and rinse with their assigned mouthwash twice daily. | Other | Brush / Hydroalcohol |
Primary outcome
Mean malodor intensity assessed at 60 minutes after product use
Time frame: After 60 minutes of 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
Mean malodor intensity assessed at 120 minutes after product use
Time frame: After 120 minutes of 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
Mean malodor intensity assessed at 180 minutes after product use
Time frame: After 180 minutes of 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
Mean malodor intensity assessed at 240 minutes after product use
Time frame: After 240 minutes of 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
Mean malodor intensity assessed at 12 hours after product use on Day 7
Time frame: After 12 hours of 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
Mean malodor intensity assessed at 12 hours after product use on Day 21
Time frame: After 12 hours of 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
24 secondary outcomes
Total volatile sulfur compounds (VSC) concentration assessed at 60 minutes after product use on Day 0
Time frame: After 60 minutes of product use
Total volatile sulfur compounds (VSC) concentration assessed at 120 minutes after product use on Day 0
Time frame: After 120 minutes of product use
Total volatile sulfur compounds (VSC) concentration assessed at 180 minutes after product use on Day 0
Time frame: After 180 minutes of product use
Total volatile sulfur compounds (VSC) concentration assessed at 240 minutes after product use on Day 0
Time frame: After 240 minutes of product use
Total volatile sulfur compounds (VSC) concentration assessed at 12 hours after product use on Day 7
Time frame: 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
Time frame: After 12 hours of product use on Day 21
Hydrogen sulfide concentration assessed at 60 minutes after product use on Day 0
Time frame: After 60 minutes of product use on Day 0
Hydrogen sulfide concentration assessed at 120 minutes after product use on Day 0
Time frame: After 120 minutes of product use on Day 0
Hydrogen sulfide concentration assessed at 180 minutes after product use on Day 0
Time frame: After 180 minutes of product use on Day 0
Hydrogen sulfide concentration assessed at 240 minutes after product use on Day 0
Time frame: After 240 minutes of product use on Day 0
Hydrogen sulfide concentration assessed at 12 hours after product use on Day 7
Time frame: After 12 hours of product use on Day 7
Hydrogen sulfide concentration assessed at 12 hours after product use on Day 21
Time frame: After 12 hours of product use on Day 21
Methyl mercaptan concentration assessed at 60 minutes after product use on Day 0
Time frame: After 60 minutes of product use on Day 0
Methyl mercaptan concentration assessed at 120 minutes after product use on Day 0
Time frame: After 120 minutes of product use on Day 0
Methyl mercaptan concentration assessed at 180 minutes after product use on Day 0
Time frame: After 180 minutes of product use on Day 0
Methyl mercaptan concentration assessed at 240 minutes after product use on Day 0
Time frame: After 240 minutes of product use on Day 0
Methyl mercaptan concentration assessed at 12 hours after product use on Day 7
Time frame: After 12 hours of product use on Day 7
Methyl mercaptan concentration assessed at 12 hours after product use on Day 21
Time frame: After 12 hours of product use on Day 21
Methyl sulfide concentration assessed at 60 minutes after product use on Day 0
Time frame: After 60 minutes of product use on Day 0
Methyl sulfide concentration assessed at 120 minutes after product use on Day 0
Time frame: After 120 minutes of product use on Day 0
Methyl sulfide concentration assessed at 180 minutes after product use on Day 0
Time frame: After 180 minutes of product use on Day 0
Methyl sulfide concentration assessed at 240 minutes after product use on Day 0
Time frame: After 240 minutes of product use on Day 0
Methyl sulfide concentration assessed at 12 hours after product use on Day 7
Time frame: After 12 hours of product use on Day 7
Methyl sulfide concentration assessed at 12 hours after product use on Day 21
Time frame: After 12 hours of product use on Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery Milleman, DDS principal investigator
Salus Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brush / Espresso Mild Prototype, Brush / Espresso Intense Prototype and Brush / Fresh Breath Oral Rinse in people with Oral Malodor, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean malodor intensity assessed at 60 minutes after product use (time frame: After 60 minutes of product use). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.