Four-Week Oral Malodor and Clinical Safety for a Concentrated Cosmetic Mouthwash (NCT06479096) | Clinical Trial Compass
CompletedNot Applicable
Four-Week Oral Malodor and Clinical Safety for a Concentrated Cosmetic Mouthwash
United States166 participantsStarted 2024-07-15
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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);
✓. 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:
✓. A minimum of 16 uncrowned teeth;
Exclusion criteria
✕. Diagnosed with Xerostomia;
✕. Suspected alcohol or substance abuse at the discretion of the Investigator (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
What they're measuring
1
Mean malodor intensity assessed at 60 minutes after product use
Timeframe: After 60 minutes of product use
2
Mean malodor intensity assessed at 120 minutes after product use
Timeframe: After 120 minutes of product use
3
Mean malodor intensity assessed at 180 minutes after product use
Timeframe: After 180 minutes of product use
4
Mean malodor intensity assessed at 240 minutes after product use
Timeframe: After 240 minutes of product use
5
Mean malodor intensity assessed at 12 hours after product use on Day 7
Timeframe: After 12 hours of product use on Day 7
6
Mean malodor intensity assessed at 12 hours after product use on Day 21
Timeframe: After 12 hours of product use on Day 21
Trial details
NCT IDNCT06479096
SponsorJohnson & Johnson Consumer and Personal Products Worldwide
✕. 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;