Mouthwash showdown: which routine tames gingivitis best?
NCT ID NCT07501455
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how different oral hygiene routines (including mouthwash) affect gum health, mouth bacteria, and inflammation in people with gingivitis. About 250 adults will use assigned products twice daily for 4 weeks, then stop for 2 weeks to see how their gums and microbiome respond. The goal is to understand which routine works best for reducing gum bleeding and plaque.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 2\. Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of gross oral neglect). 3\. Mean Modified Gingival Index (MGI) is greater than or equal to 2.00 at screening visit and reconfirmed at baseline visit. 4\. Bleeding upon probing (BOP) is greater than or equal to 30% at the screening visit. 5\. Diagnosis of gingivitis (confirmed by MGI and BOP) at the screening visit and reconfirmed at the baseline visit. 6\. Able to read and understand English. 7. Subject has signed the written informed consent (ICD) and indicated their agreement with the terms of the study and the study procedures listed and photograph release including the Health Insurance Portability and Accountability Act (HIPAA) disclosure prior to any study-related procedures. 8\. Generally, in good overall health based on the medical history reported by the subject. 9\. Has at least 18 natural teeth (not counting 3rd molars) with scorable facial and lingual surfaces. 10\. Willingness to use the assigned products according to instructions, availability for appointments, agreement to follow the subject responsibilities and likelihood of completing the clinical trial Exclusion Criteria: 1. Significant oral soft tissue pathology or active dental caries, based on the dentist's visual examination and at the discretion of the Investigator. 2. History of significant adverse reactions, including sensitivity or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses, and red food dye. 3. Periodontitis, as determined by more than 2 sites with a probing depth greater than 4mm. 4. Regular consumption of probiotics supplements within one week prior to screening. Subjects can be rescreened if they fulfill this criterion. 5. Dental prophylaxis within 4 weeks prior to screening. Subjects can be rescreened if they fulfill this criterion. 6. Subjects who wear orthodontic bands, fixed retainers, removable orthodontic appliances, clear aligners or night guards or subjects who have had significant (based on the examiner or PI's oral exam) cosmetic restorations. 7. History of medical conditions requiring prophylactic antibiotic coverage prior to dental procedures. 8. Self-reported tobacco, cannabis, smokeless tobacco use, including snuff, chewing tobacco, vaping, and e-cigarette usage. 9. Suspected alcohol or substance abuse. 10. Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of the Investigator, including a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study. 11. Has self-reported Type 1 or Type 2 diabetes or is on an anti-diabetic medication (i.e., metformin, insulin, Glucophage, etc.) 12. Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including: * Non-steroidal anti-inflammatory drugs within 5 days before Visit 1 (81mg of aspirin is allowed).\* * Use of Immunosuppressive, or steroidal drugs therapy during the study or within 2 months before Visit 2. \* Intermittent use (\<3 times per week) of certain anti-inflammatory medications is acceptable at the discretion of the investigator. Use of anticoagulant therapy within 1 month of screening visit or during the study. * Use of systemic antibiotics within 1 month of screening visit and during the entire study. 13. Is self-reported to be pregnant, in lactation, planning to become pregnant during the study, or positive 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. * 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 * 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. 14. Participation in any clinical trial within 30 days of the Screening visit. 15. Subjects who were previously randomized into one of the study products as part of this study. 16. Subjects who are related to the people who are involved directly or indirectly with the conduct of this study (i.e., principal Investigator, sub-investigators, study coordinators, other site personnel, employees of Kenvue, contractors of Kenvue, and the families of each). 17. Subjects within the same household as other subjects enrolled in the study at the same time.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The ADA Forsyth Institute
RECRUITINGSomerville, Massachusetts, 02143, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a toothbrush and mouthwash cut pneumonia in the elderly?
- Electric flosser may tackle plaque and gum bleeding better than brushing alone