GingivitisPhase 4NCT07614490
Clinical Study to Collect and Analyze Dental Plaque and Oral Health Measures in a Population With High Plaque/Low Gingivitis and High Plaque/High Gingivitis
A Phase 4 study testing sodium monofluorophosphate toothpaste in people with Gingivitis and Plaque, run by Colgate Palmolive at 1 site in United States.
Trial summary
The objective of this clinical research study is to collect and analyze plaque and oral health measures in a population with high plaque/low gingivitis and high plaque/high gingivitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis, Plaque
- What is being tested?
- sodium monofluorophosphate toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to 15 Oct 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female volunteers at least 18 years of age and in general good health.
- Willing and able to understand and sign the informed consent form.
- Must have a whole mouth mean TPI score ≥ 3.25
- N=40 must have moderate-severe gingivitis (Whole Mouth Mean MGI≥2.5 or percent bleeding sites based on EBI ≥20%) and N=40 must have mild gingivitis (Whole Mouth Mean MGI≤2.5 and percent bleeding sites based on EBI<20%)
- Must have at least two areas in the mouth with high plaque/low inflammation and two areas with high plaque/high inflammation
- Be willing to conform to the study protocol and procedures.
- Minimum of 20 natural teeth with scorable facial and lingual surfaces
Who cannot join
- Medical condition which requires premedication prior to dental visits/procedure.
- Known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
- Active disease of the hard oral tissues.
- Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
- Subjects with fixed or removable orthodontic appliances or removable partial dentures.
- Dental prophylaxis within 30 days prior to study start.
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- Use of antibiotics, antimicrobial drugs, anti-inflammatory drugs, or anticoagulant therapies within 30 days prior to study start.
- Use of chemotherapeutic oral care products within two weeks prior to study start.
- Participation in any other clinical study within 30 days prior to enrollment into this study.
- Subjects who must receive dental treatment during the study dates.
- Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
- Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse.
- Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)
- Pregnant or lactating subjects, or subjects planning to become pregnant during the course of the study.
- Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
- Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
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, 1 recruiting
- Recruiting
Salus Research, Inc.
Fort Wayne, Indiana, 46825
Jeffery Milleman, DDS, MPA, 260-755-1099, Milleman@salusresearch.us
Jeffery Milleman, DDS, MPA
About this study
The objective of this clinical research study is to collect and analyze plaque and oral health measures in a population with high plaque/low gingivitis and high plaque/high gingivitis
Read the detailed description
This study is a single-arm clinical trial. Up to one hundred (100) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in order to complete the study with eighty (80) subjects. Subjects will undergo oral examinations, gingival crevicular fluid collection, saliva collection, plaque collection, and will complete questionnaires. All subjects will all be supplied with a study toothbrush and toothpaste.
- Conditions
- Gingivitis, Plaque
- Being tested
- sodium monofluorophosphate toothpaste
- Medical subject headings
- Gingivitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium monofluorophosphate toothpasteDrug
All subjects will receive the same treatment for standardization
| Study group | Role | What they receive |
|---|---|---|
| Brushing with sodium fluoride toothpaste | Other | Not described Receives: Drug: sodium monofluorophosphate toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance of Streptococcus and Porphyromonas
Comparative relative abundance of Streptococcus and Porphyromonas in sites with high plaque/low gingivitis and high plaque/high gingivitis at Visit 3
Measured: 23-26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start20 Apr 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriella John, MS, Study director, Colgate Palmolive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614490
- Sponsor's protocol ID
- CRO-2026-Sampling-CB-PG-GJ
- Status last verified
- May 2026
- First submitted
- 17 Apr 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depends on the inquiry
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Collect and Analyze Dental Plaque and Oral Health Measures in a Population With High Plaque/Low Gingivitis and High Plaque/High Gingivitis
- ClinicalTrials.gov ID
- NCT07614490
- Acronym / sponsor ID
- CRO-2026-Sampling-CB-PG-GJ
- Conditions
- Gingivitis, Plaque
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 29 May 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.
The objective of this clinical research study is to collect and analyze plaque and oral health measures in a population with high plaque/low gingivitis and high plaque/high gingivitis
Detailed description
This study is a single-arm clinical trial. Up to one hundred (100) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in order to complete the study with eighty (80) subjects. Subjects will undergo oral examinations, gingival crevicular fluid collection, saliva collection, plaque collection, and will complete questionnaires. All subjects will all be supplied with a study toothbrush and toothpaste.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brushing with sodium fluoride toothpaste | Other | Drug: sodium monofluorophosphate toothpaste |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female volunteers at least 18 years of age and in general good health.
- Willing and able to understand and sign the informed consent form.
- Must have a whole mouth mean TPI score ≥ 3.25
- N=40 must have moderate-severe gingivitis (Whole Mouth Mean MGI≥2.5 or percent bleeding sites based on EBI ≥20%) and N=40 must have mild gingivitis (Whole Mouth Mean MGI≤2.5 and percent bleeding sites based on EBI<20%)
- Must have at least two areas in the mouth with high plaque/low inflammation and two areas with high plaque/high inflammation
Key exclusion criteria (16 listed)
- Medical condition which requires premedication prior to dental visits/procedure.
- Known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
- Active disease of the hard oral tissues.
- Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
- Subjects with fixed or removable orthodontic appliances or removable partial dentures.
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 |
|---|---|---|
| sodium monofluorophosphate toothpasteAll subjects will receive the same treatment for standardization | Drug | Brushing with sodium fluoride toothpaste |
Primary outcome
Relative abundance of Streptococcus and Porphyromonas
Time frame: 23-26 days
Comparative relative abundance of Streptococcus and Porphyromonas in sites with high plaque/low gingivitis and high plaque/high gingivitis at Visit 3
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 29 May 2026.
- Individual participant dataSharing planned: Undecided. Depends on the inquiry
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
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.
Gabriella John, MS study director
Colgate Palmolive
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium monofluorophosphate toothpaste in people with Gingivitis and Plaque, run by Colgate Palmolive 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 7 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 29 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jeffery Milleman, DDS, MPA (260-755-1099, milleman@salusresearch.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative abundance of Streptococcus and Porphyromonas (time frame: 23-26 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 29 May 2026.