MicrobiomeNCT07501455
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
A study testing Distilled Water, Marketed Comparator 1 and Marketed Comparator 2 in people with Microbiome and Cytokines, run by Kenvue Brands LLC at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiome, Cytokines, Plaque
- What is being tested?
- Distilled Water, Marketed Comparator 1 and Marketed Comparator 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 21 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Significant oral soft tissue pathology or active dental caries, based on the dentist's visual examination and at the discretion of the Investigator.
- 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.
- Periodontitis, as determined by more than 2 sites with a probing depth greater than 4mm.
- Regular consumption of probiotics supplements within one week prior to screening. Subjects can be rescreened if they fulfill this criterion.
- Dental prophylaxis within 4 weeks prior to screening. Subjects can be rescreened if they fulfill this criterion.
- 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.
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- History of medical conditions requiring prophylactic antibiotic coverage prior to dental procedures.
- Self-reported tobacco, cannabis, smokeless tobacco use, including snuff, chewing tobacco, vaping, and e-cigarette usage.
- Suspected alcohol or substance abuse.
- 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.
- Has self-reported Type 1 or Type 2 diabetes or is on an anti-diabetic medication (i.e., metformin, insulin, Glucophage, etc.)
- 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.
- 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.
- Participation in any clinical trial within 30 days of the Screening visit.
- Subjects who were previously randomized into one of the study products as part of this study.
- 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).
- Subjects within the same household as other subjects enrolled in the study at the same time.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The ADA Forsyth Institute
Somerville, Massachusetts, 02143
About this study
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.
- Conditions
- Microbiome, Cytokines, Plaque, Gingivitis, Gingival Bleeding
- Being tested
- Distilled Water, Marketed Comparator 1, Marketed Comparator 2, Prototype Rinse 1, Prototype Rinse 2
- Medical subject headings
- Plaque, Amyloid, Gingivitis, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distilled WaterOther
Subjects will brush and rinse with distilled water twice daily.
Marketed Comparator 1Other
Subjects will brush and rinse with their assigned mouthwash twice daily.
Marketed Comparator 2Other
Subjects will brush and rinse with their assigned mouthwash twice daily.
Prototype Rinse 1Other
Subjects will brush and rinse with their assigned mouthwash twice daily.
Prototype Rinse 2Other
Subjects will brush and rinse with their assigned mouthwash twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Brush / Rinse (Distilled Water) | Placebo comparator | 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. Receives: Other: Distilled Water |
| Brush / Rinse (Experimental Prototype 1) | Experimental | 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. Receives: Other: Prototype Rinse 1 |
| Brush / Rinse (Experimental Prototype 2) | Experimental | 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. Receives: Other: Prototype Rinse 2 |
| Brush / Rinse (Marketed Comparator 1) | Active comparator | 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. Receives: Other: Marketed Comparator 1 |
| Brush / Rinse (Marketed Comparator 2) | Active comparator | 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. Receives: Other: Marketed Comparator 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in profiles in supragingival plaque microbiome samples
Microbiome analysis will be conducted by ADA-Forsyth's Oral Microbiome Core.
Measured: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Secondary outcomes (6)
Changes in microbiome profiles - Subgingival plaque samples - Saliva samples -Tongue biofilm samples
Microbiome analysis will be conducted by ADA-Forsyth's Oral Microbiome Core
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start26 Feb 2026
- Primary completion21 Apr 2027 (estimated)
- Study completion21 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenvue Brands LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501455
- Sponsor's protocol ID
- CS2025OC100266
- Status last verified
- 24 Jul 2026
- First submitted
- 6 Mar 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
- ClinicalTrials.gov ID
- NCT07501455
- Acronym / sponsor ID
- CS2025OC100266
- Conditions
- Microbiome, Cytokines, Plaque, Gingivitis, Gingival Bleeding
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Kenvue Brands LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 21 Apr 2027 (estimated)
- Study completion
- 21 Apr 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Brush / Rinse (Distilled Water) | Placebo comparator | Other: Distilled WaterAll 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. |
| Brush / Rinse (Experimental Prototype 1) | Experimental | Other: Prototype Rinse 1All 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. |
| Brush / Rinse (Experimental Prototype 2) | Experimental | Other: Prototype Rinse 2All 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. |
| Brush / Rinse (Marketed Comparator 1) | Active comparator | Other: Marketed Comparator 1All 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. |
| Brush / Rinse (Marketed Comparator 2) | Active comparator | Other: Marketed Comparator 2All 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (28 listed)
- Significant oral soft tissue pathology or active dental caries, based on the dentist's visual examination and at the discretion of the Investigator.
- 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.
- Periodontitis, as determined by more than 2 sites with a probing depth greater than 4mm.
- Regular consumption of probiotics supplements within one week prior to screening. Subjects can be rescreened if they fulfill this criterion.
- Dental prophylaxis within 4 weeks prior to screening. Subjects can be rescreened if they fulfill this criterion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distilled WaterSubjects will brush and rinse with distilled water twice daily. | Other | Brush / Rinse (Distilled Water) |
| Marketed Comparator 1Subjects will brush and rinse with their assigned mouthwash twice daily. | Other | Brush / Rinse (Marketed Comparator 1) |
| Marketed Comparator 2Subjects will brush and rinse with their assigned mouthwash twice daily. | Other | Brush / Rinse (Marketed Comparator 2) |
| Prototype Rinse 1Subjects will brush and rinse with their assigned mouthwash twice daily. | Other | Brush / Rinse (Experimental Prototype 1) |
| Prototype Rinse 2Subjects will brush and rinse with their assigned mouthwash twice daily. | Other | Brush / Rinse (Experimental Prototype 2) |
Primary outcome
Changes in profiles in supragingival plaque microbiome samples
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Microbiome analysis will be conducted by ADA-Forsyth's Oral Microbiome Core.
6 secondary outcomes
Changes in microbiome profiles - Subgingival plaque samples - Saliva samples -Tongue biofilm samples
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)
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)
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
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)
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
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distilled Water, Marketed Comparator 1 and Marketed Comparator 2 in people with Microbiome and Cytokines, run by Kenvue Brands LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in profiles in supragingival plaque microbiome samples (time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.