An interventional study of Distilled Water and Marketed Comparator 1 in Microbiome, Cytokines and Plaque, sponsored by Kenvue Brands LLC. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Kenvue Brands LLC · Not applicable, Interventional, and Basic science
This study is a six-week, double-blind, randomized, parallel-group controlled clinical study. The objective of this study is to evaluate the changes to the oral microbiome, inflammatory mediators, gingival health indices and to assess oral tolerance after 4 weeks of twice daily use of differing oral hygiene regimens including mouthwash compared to a control group. A follow-up assessment will be completed 2 weeks after cessation of treatments.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 250 is above the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Kenvue Brands LLC is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (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:
Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
Is self-reported to be pregnant, in lactation, planning to become pregnant during the study, or positive pregnancy urine tests (females of 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will receive 2 tubes of a marketed fluoride-containing dentifrice (Crest® Cavity Protection Toothpaste) and 1 soft, flat trimmed bristled toothbrush at their Baseline visit to use throughout the study. The subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for one-timed minute with the toothpaste and toothbrush provided. After brushing for 1-timed minute, subjects will rinse with provided distilled water according to the label instructions. Subjects will be required to record their twice-daily product usage in a subject diary.
Other: Distilled Water
All subjects will receive 2 tubes of a marketed fluoride-containing dentifrice (Crest® Cavity Protection Toothpaste) and 1 soft, flat trimmed bristled toothbrush at their Baseline visit to use throughout the study. The subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for one-timed minute with the toothpaste and toothbrush provided. After brushing for 1-timed minute, subjects will rinse with their assigned mouthrinse according to the label instructions. Subjects will be required to record their twice-daily product usage in a subject diary.
Other: Prototype Rinse 1
All subjects will receive 2 tubes of a marketed fluoride-containing dentifrice (Crest® Cavity Protection Toothpaste) and 1 soft, flat trimmed bristled toothbrush at their Baseline visit to use throughout the study. subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for one-timed minute with the toothpaste and toothbrush provided. They will place a full ribbon of toothpaste across the length of the provided toothbrush. After brushing for 1-timed minute, subjects will rinse with their assigned mouthrinse according to the label instructions. Subjects will be required to record their twice-daily product usage in a subject diary.
Other: Prototype Rinse 2
All subjects will receive 2 tubes of a marketed fluoride-containing dentifrice (Crest® Cavity Protection Toothpaste) and 1 soft, flat trimmed bristled toothbrush at their Baseline visit to use throughout the study. The subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for one-timed minute with the toothpaste and toothbrush provided. After brushing for 1-timed minute, subjects will rinse with their assigned mouthrinse according to the label instructions. Subjects will be required to record their twice-daily product usage in a subject diary.
Other: Marketed Comparator 1
All subjects will receive 2 tubes of a marketed fluoride-containing dentifrice (Crest® Cavity Protection Toothpaste) and 1 soft, flat trimmed bristled toothbrush at their Baseline visit to use throughout the study. The subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for one-timed minute with the toothpaste and toothbrush provided. After brushing for 1-timed minute, subjects will rinse with their assigned mouthrinse according to the label instructions. Subjects will be required to record their twice-daily product usage in a subject diary.
Other: Marketed Comparator 2
Subjects will brush and rinse with distilled water twice daily.
Subjects will brush and rinse with their assigned mouthwash twice daily.
Subjects will brush and rinse with their assigned mouthwash twice daily.
Subjects will brush and rinse with their assigned mouthwash twice daily.
Subjects will brush and rinse with their assigned mouthwash twice daily.
Changes in profiles in supragingival plaque microbiome samples
Microbiome analysis will be conducted by ADA-Forsyth's Oral Microbiome Core.
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in microbiome profiles - Subgingival plaque samples - Saliva samples -Tongue biofilm samples
Microbiome analysis will be conducted by ADA-Forsyth's Oral Microbiome Core
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in clinical periodontal parameters compared to baseline and a control grop: • Expanded Bleeding Index (EBI)
The EBI will be analyzed using analysis of co-variance (ANCOVA) with investigational product as a factor and baseline as covariate Between-group comparison of each investigational group versus negative control or each marketed control group will be performed in the model.
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in clinical periodontal parameters compared to baseline and a control group: • Amount of plaque measured by Turesky modification of Quigley-Hein Plaque Index (TPI)
The TPI will be analyzed using analysis of co-variance (ANCOVA) with investigational product as a factor and baseline as covariate Between-group comparison of each investigational group versus negative control or each marketed control group will be performed in the model.
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days
Changes in clinical periodontal parameters compared to baseline and a control group: • Periodontal pocket depth
The periodontal pocket depth will be analyzed using analysis of co-variance (ANCOVA) with investigational product as a factor and baseline as covariate Between-group comparison of each investigational group versus negative control or each marketed control group will be performed in the model.
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in clinical periodontal parameters compared to baseline and a control group: • Bleeding on probing (BOP)
The BOP will be analyzed using analysis of co-variance (ANCOVA) with investigational product as a factor and baseline as covariate Between-group comparison of each investigational group versus negative control or each marketed control group will be performed in the model.
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in clinical periodontal parameters compared to baseline and a control group • Gingival inflammation
Gingival inflammation measured by Modified Gingival Index (MGI)
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kenvue Brands LLC