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

NCT ID: NCT06479096

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2024-09-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brush / Espresso Mild Prototype

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.

Group Type: EXPERIMENTAL

Brush / Espresso Mild Prototype

Intervention Type: OTHER

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

Brush / Espresso Intense Prototype

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.

Group Type: EXPERIMENTAL

Brush / Espresso Intense Prototype

Intervention Type: OTHER

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

Brush / Fresh Breath Oral Rinse

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.

Group Type: ACTIVE_COMPARATOR

Brush / Fresh Breath Oral Rinse

Intervention Type: OTHER

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

Brush / Hydroalcohol

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.

Group Type: PLACEBO_COMPARATOR

Brush / Hydroalcohol

Intervention Type: OTHER

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

Interventions

Brush / Espresso Mild Prototype

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

Intervention Type: OTHER

Brush / Espresso Intense Prototype

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

Intervention Type: OTHER

Brush / Fresh Breath Oral Rinse

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

Intervention Type: OTHER

Brush / Hydroalcohol

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffery Milleman, DDS

Role: PRINCIPAL_INVESTIGATOR

Salus Research Inc.

Locations

Salus Research, Inc.

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

CS2024OC100108

Identifier Type: -

Identifier Source: org_study_id