Clinical trial NCT06479096: Four-Week Oral Malodor and Clinical Safety for a Concentrated Cosmetic Mouthwash
Official title: Four-Week Oral Malodor and Clinical Safety for a Concentrated Cosmetic Mouthwash
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Malodor
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2024-06-27
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 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;
2. 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;
3. Able to read and understand the local language (subject is capable of reading the documents);
4. Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);
5. Adults, 18 years of age and older, in good general and oral health without any known allergy to commercial dental products or cosmetics;
6. Negative pregnancy urine tests (females of child-bearing potential only);

   * 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.
7. 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
8. A minimum of 16 uncrowned teeth;
9. 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;
10. At Baseline (Visit 2), before brushing with assigned dentifrice, subjects must provide a breath sample with a mean organoleptic score ≥3.5 across judges;
11. 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
12. Absence of partial dentures, dentures, orthodontic bands, fixed retainers, removable orthodontic appliances.

Exclusion Criteria:

1. Diagnosed with Xerostomia;
2. Suspected alcohol or substance abuse at the discretion of the Investigator (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
3. Known sensitivity, allergy or contraindications to any investigational product ingredient, oral care products and auxiliary supplies provided for the study;
4. Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e-cigarette usage;
5. Females who are pregnant, planning to become pregnant or breastfeeding during the study;
6. 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;
7. Participation in any clinical study investigation within 30 days of Screening visit (Visit 1);
8. Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period;
9. Has a compromised immune system;
10. 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;
11. Significant, unstable or uncontrolled medical condition which may interfere with subject's participation in the study, at the discretion of the Investigator; and
12. 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).

Primary outcomes:
measure: Mean malodor intensity assessed at 60 minutes after product use
timeFrame: After 60 minutes of product use
measure: Mean malodor intensity assessed at 120 minutes after product use
timeFrame: After 120 minutes of product use
measure: Mean malodor intensity assessed at 180 minutes after product use
timeFrame: After 180 minutes of product use
measure: Mean malodor intensity assessed at 240 minutes after product use
timeFrame: After 240 minutes of product use
measure: Mean malodor intensity assessed at 12 hours after product use on Day 7
timeFrame: After 12 hours of product use on Day 7
measure: Mean malodor intensity assessed at 12 hours after product use on Day 21
timeFrame: After 12 hours of product use on Day 21
Secondary outcomes:
measure: Total volatile sulfur compounds (VSC) concentration assessed at 60 minutes after product use on Day 0
timeFrame: After 60 minutes of product use
measure: Total volatile sulfur compounds (VSC) concentration assessed at 120 minutes after product use on Day 0
timeFrame: After 120 minutes of product use
measure: Total volatile sulfur compounds (VSC) concentration assessed at 180 minutes after product use on Day 0
timeFrame: After 180 minutes of product use
measure: Total volatile sulfur compounds (VSC) concentration assessed at 240 minutes after product use on Day 0
timeFrame: After 240 minutes of product use
measure: Total volatile sulfur compounds (VSC) concentration assessed at 12 hours after product use on Day 7
timeFrame: After 12 hours of product use on Day 7
measure: Total volatile sulfur compounds (VSC) concentration assessed at 12 hours after product use on Day 21
timeFrame: After 12 hours of product use on Day 21
measure: Hydrogen sulfide concentration assessed at 60 minutes after product use on Day 0
timeFrame: After 60 minutes of product use on Day 0
measure: Hydrogen sulfide concentration assessed at 120 minutes after product use on Day 0
timeFrame: After 120 minutes of product use on Day 0
measure: Hydrogen sulfide concentration assessed at 180 minutes after product use on Day 0
timeFrame: After 180 minutes of product use on Day 0
measure: Hydrogen sulfide concentration assessed at 240 minutes after product use on Day 0
timeFrame: After 240 minutes of product use on Day 0
measure: Hydrogen sulfide concentration assessed at 12 hours after product use on Day 7
timeFrame: After 12 hours of product use on Day 7
measure: Hydrogen sulfide concentration assessed at 12 hours after product use on Day 21
timeFrame: After 12 hours of product use on Day 21
measure: Methyl mercaptan concentration assessed at 60 minutes after product use on Day 0
timeFrame: After 60 minutes of product use on Day 0
measure: Methyl mercaptan concentration assessed at 120 minutes after product use on Day 0
timeFrame: After 120 minutes of product use on Day 0
measure: Methyl mercaptan concentration assessed at 180 minutes after product use on Day 0
timeFrame: After 180 minutes of product use on Day 0
measure: Methyl mercaptan concentration assessed at 240 minutes after product use on Day 0
timeFrame: After 240 minutes of product use on Day 0
measure: Methyl mercaptan concentration assessed at 12 hours after product use on Day 7
timeFrame: After 12 hours of product use on Day 7
measure: Methyl mercaptan concentration assessed at 12 hours after product use on Day 21
timeFrame: After 12 hours of product use on Day 21
measure: Methyl sulfide concentration assessed at 60 minutes after product use on Day 0
timeFrame: After 60 minutes of product use on Day 0
measure: Methyl sulfide concentration assessed at 120 minutes after product use on Day 0
timeFrame: After 120 minutes of product use on Day 0
measure: Methyl sulfide concentration assessed at 180 minutes after product use on Day 0
timeFrame: After 180 minutes of product use on Day 0
measure: Methyl sulfide concentration assessed at 240 minutes after product use on Day 0
timeFrame: After 240 minutes of product use on Day 0
measure: Methyl sulfide concentration assessed at 12 hours after product use on Day 7
timeFrame: After 12 hours of product use on Day 7
measure: Methyl sulfide concentration assessed at 12 hours after product use on Day 21
timeFrame: After 12 hours of product use on Day 21
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research, Inc.
state: Indiana
Study officials:
affiliation: Salus Research Inc.
name: Jeffery Milleman, DDS
role: PRINCIPAL_INVESTIGATOR
References: