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CompletedNCT07917507Updated Nov 10, 2026

Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis

A Phase 3 interventional study of 0.412% stannous fluoride toothpaste and flat trimmed toothbrush and 0.76% Na MFP and flat trimmed toothbrush in Plaque and Gingivitis, sponsored by Colgate Palmolive. Completed at 1 site in Dominican Republic. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Colgate Palmolive · Phase 3, Interventional, and Treatment

Updated Nov 10, 2026Now CompletedPrimary completion moved+4 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Clinical Research study to assess the efficacy of two brushing regimens: 1) a toothpaste containing stannous fluoride and a standard manual toothbrush as compared to 2) a regular fluoride toothpaste and standard manual toothbrush in the reduction of established dental plaque and gingivitis

02

Conditions studied

  • Plaque
  • Gingivitis

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03

In context

Gingivitis

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

This study's enrollment of 84 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.

Browse Colgate Palmolive studies →

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Signed Form.
  • Male and female subjects aged 18-70 years, inclusive.
  • Availability for the 24 weeks (6 months) duration of the clinical research study.
  • Good general health based on the opinion of the study investigator
  • Minimum of 20 permanent natural teeth (excluding third molars).
  • Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
  • Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).

Exclusion criteria

Exclusion Criteria:

  • Presence of orthodontic appliances.
  • Presence of partial removable dentures.
  • Tumor(s) of the soft or hard tissues of the oral cavity.
  • Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
  • Five or more carious lesions requiring immediate restorative treatment.
  • Antibiotic use any time during the one-month period prior to entry into the study.
  • Participation in any other clinical study or test panel within the one month prior to entry into the study.
  • Dental prophylaxis during the past two weeks prior to baseline examinations.
  • History of allergies to oral care/personal care consumer products or their ingredients.
  • On any prescription medicines that might interfere with the study outcome.
  • An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
  • History of alcohol and/or drug abuse.
  • Self-reported pregnancy and/or lactating subjects.
Terms in these criteria, in plain language(1)

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    test 1

    Brush with a full ribbon, 2x day / 2mins

    Drug: 0.412% stannous fluoride toothpaste and flat trimmed toothbrush

  • Active comparator
    test 2

    Brush with a full ribbon, 2x day / 2mins

    Drug: 0.76% Na MFP and flat trimmed toothbrush

Interventions

  • Drug0.412% stannous fluoride toothpaste and flat trimmed toothbrush

    Brush with full ribbon, 2x day / 2mins

  • Drug0.76% Na MFP and flat trimmed toothbrush

    Brush with full ribbon, 2x day / 2mins

06

What researchers measure

Primary outcomes

  1. Loe-Silness Gingival Index

    score from 0 to 3 will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scorable surface and dividing that number by the total number of surfaces scored

    Time frame: Baseline, 12 weeks (3 months), 24 weeks (6 months)

  2. Turesky-modified Quigley-Hein Plaque Index

    Using a red dye solution to disclose the plaque. A score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored

    Time frame: Baseline, 12 weeks (3 months), 24 weeks (6 months)

07

Study locations

1 site
  • Spa Dental
    Santo Domingo, 10148, Dominican Republic
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2026 to primary completion in Nov 2026, 0 months.

Of 23 industry-sponsored phase 3 interventional studies under Gingivitis, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 6. This study's 0 months is below that.

Counting every sponsor, half of 35 studies reached it within 3 months; a quarter within 2 and three quarters within 6.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Apr 2027 → Nov 2026 and completion Apr 2027 → Nov 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2026
First posted
Nov 4, 2026
StartActual
Oct 9, 2026
Primary completionActual
Nov 4, 2026was Apr 2027
CompletionActual
Nov 4, 2026was Apr 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Completed
changed Nov 10, 2026
Primary completion
Apr 2027→Nov 4, 2026 (actual)
Nov 10, 2026
Study completion
Apr 2027→Nov 4, 2026 (actual)
Nov 10, 2026
Interventions
Arms added: test 1·test 2; arms removed: Toothpaste·toothpaste
Nov 10, 2026
Title
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Nov 10, 2026
Registered
First appeared on the registry
Nov 4, 2026
Show all 2 updates
  1. Nov 10, 2026
    Active, not recruiting→Completed
    Primary completion Apr 2027→Nov 4, 2026 (now actual)
    Study completion Apr 2027→Nov 4, 2026 (now actual)
    Interventions Arms added: test 1·test 2; arms removed: Toothpaste·toothpaste
    Title A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
    + 1 other change: oversight details
  2. Nov 4, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07917507
Lead sponsor
Colgate Palmolive
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Oct 9, 2026
Primary completion
Nov 4, 2026
Completion
Nov 4, 2026
Last update
Nov 10, 2026

Study contacts

Antonio Cepeda-Bravo, D.D.S., M.S
principal investigator · Universidad Autonoma de San Luis Potosí

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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