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CompletedNCT07211061Updated Oct 7, 2025

A Study is to Evaluate a Regimen on Gingivitis Using Traditional and Novel Assessment Methods

A Phase 4 interventional study of Stannous Fluoride Dentifrice and Sodium Fluoride Dentifrice in Gingivitis, sponsored by Procter and Gamble. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-07.

Sponsored by Procter and Gamble · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 14 years after the study started (first participant enrolled Sep 2011, registered Sep 2025).
Phase
Phase 4
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Each subject will be randomly assigned to one of two treatment products. The regimen group will be asked to brush 2x a day in using a power brush (2 minutes of brushing), followed by using 20 ml of mouth rinse for 30 seconds for 6 weeks. The negative control group will be asked to brush 2x a day using a manual toothbrush in their customary manner for 6 weeks. Oral Soft Tissue (OST) assessments, gingivitis and plaque measurements will be taken at 4 time-points: Baseline (BL); Week 1; Week 3; and Week 6.

02

Conditions studied

  • 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 69 is close to the median of 66 across 507 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Procter and Gamble is the lead sponsor of 83 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

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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
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

  • Provide written to participate in the study;
  • Be 18 years of age or older;
  • Agree not to participate in any other oral/dental product studies during the course of this study;
  • Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
  • Agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products;
  • Have a Baseline MGI score of at least 1.75 but not greater than 2.3;
  • Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);
  • Agree to return for all scheduled visits and follow study procedures;
  • Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Have had a dental prophylaxis within 2 weeks of Baseline visit;
  • Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
  • Have rampant caries, open or untreated caries, severe gingivitis, or advanced periodontitis requiring prompt treatment; or,
  • Need an antibiotic prophylaxis prior to dental visits,
  • Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study,
  • Are pregnant (Self-reported) or lactating.
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 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    Oral Hygiene Regimen

    toothpaste, electric toothbrush, and mouth rinse

    Drug: Stannous Fluoride Dentifrice · Device: electric toothbrush · Drug: Cetylpyridinium Chloride (CPC)

  • Active comparator
    Negative Control

    toothpaste and manual toothbrush

    Drug: Sodium Fluoride Dentifrice · Device: manual toothbrush

Interventions

06

What researchers measure

Primary outcomes

  1. Bleeding (GBI)

    Gingival Bleeding Index- evaluation of bleeding from gingival tissue, score from 0-2

    Time frame: Week 1, Week 3, and Week 6

Secondary outcomes

  1. Inflammation (MGI)

    Modified Gingival Index- evaluation of the level of gingival tissue inflammation, scores from 0-4

    Time frame: Week 1, Week 3, and Week 6

07

Study locations

1 site
  • Bio-Sci Research (Out of Business)
    Las Vegas, Nevada 89121, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar 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 Sep 2011 to primary completion in Nov 2011, 1 month.

Of 25 phase 4 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 4. This study's 1 month is below that.

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

Registered
Sep 29, 2025
First posted
Oct 7, 2025
StartActual
Sep 21, 2011
Primary completionActual
Nov 10, 2011
CompletionActual
Nov 10, 2011
Last update
Oct 7, 2025
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.
No changes since tracking began. The registry record was last updated on Oct 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07211061
Lead sponsor
Procter and Gamble
Responsible party
Sponsor
First posted
Oct 7, 2025
Start date
Sep 21, 2011
Primary completion
Nov 10, 2011
Completion
Nov 10, 2011
Last update
Oct 7, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Tin Fluorides · Cetylpyridinium

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