Four-Week Oral Malodor and Clinical Safety for a Concentrated Cosmetic Mouthwash

NCT06479096 | Completed

• 1 other identifier: CS2024OC100108
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Malodor

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (24)

• Total volatile sulfur compounds (VSC) concentration assessed at 60 minutes after product use on Day 0

  After 60 minutes of product use

• Total volatile sulfur compounds (VSC) concentration assessed at 120 minutes after product use on Day 0

  After 120 minutes of product use

• Total volatile sulfur compounds (VSC) concentration assessed at 180 minutes after product use on Day 0

  After 180 minutes of product use

• Total volatile sulfur compounds (VSC) concentration assessed at 240 minutes after product use on Day 0

  After 240 minutes of product use

• Total volatile sulfur compounds (VSC) concentration assessed at 12 hours after product use on Day 7

  After 12 hours of product use on Day 7

Study Arms (4)

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.

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.

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.

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.

Other: Brush / Hydroalcohol

Interventions

Brush / Espresso Mild Prototype OTHER

Subjects will brush and rinse with their assigned mouthwash twice daily.

Brush / Espresso Mild Prototype

Brush / Espresso Intense Prototype OTHER

Subjects will brush and rinse with their assigned mouthwash twice daily.

Brush / Espresso Intense Prototype

Brush / Fresh Breath Oral Rinse OTHER

Subjects will brush and rinse with their assigned mouthwash twice daily.

Brush / Fresh Breath Oral Rinse

Brush / Hydroalcohol OTHER

Subjects will brush and rinse with their assigned mouthwash twice daily.

Brush / Hydroalcohol

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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;

You may not qualify if:

• 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;
• 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).

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Interventions

Toothbrushing

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Officials

• Jeffery Milleman, DDS

  Salus Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Examiner-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 27, 2024
• Study Start: July 15, 2024
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: January 8, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)