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RecruitingNCT07614490Updated May 29, 2026

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 interventional study of sodium monofluorophosphate toothpaste in Gingivitis and Plaque, sponsored by Colgate Palmolive. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Colgate Palmolive · Phase 4, Interventional, and Basic science

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gingivitis
  • Plaque

Browse trials for

03

In context

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's planned enrollment of 100 is above the median of 66 across 507 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Colgate Palmolive is the lead sponsor of 119 studies on the registry; 13 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Male or female volunteers at least 18 years of age and in general good health.
  • Willing and able to understand and sign the 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
  • individuals (, 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).
Terms in these criteria, in plain language(3)

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.

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.

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Brushing with sodium fluoride toothpaste

    Drug: sodium monofluorophosphate toothpaste

Interventions

  • Drugsodium monofluorophosphate toothpaste

    All subjects will receive the same treatment for standardization

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 23-26 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Depends on the inquiry

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07614490
Lead sponsor
Colgate Palmolive
Responsible party
Sponsor
First posted
May 29, 2026
Start date
Apr 20, 2026
Primary completion
Sep 30, 2026 (estimated)
Completion
Oct 15, 2026 (estimated)
Last update
May 29, 2026

Study contacts

Jeffery Milleman, DDS, MPA
Contact
milleman@salusresearch.us
260-755-1099
Gabriella John, MS
study director · Colgate Palmolive

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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