CompletedNCT06300866Updated Mar 8, 2024

Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste

A Phase 3 interventional study of Test and Control in Gingivitis and Plaque, Dental, sponsored by Colgate Palmolive. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-08.

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

From the registry’s dates

Primary completion was Mar 2021, 5 years 7 months ago, and no results have been posted to the registry.
Registered 3 years 6 months after the study started (first participant enrolled Aug 2020, registered Mar 2024).

Phase: Phase 3
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use.

Conditions studied

Gingivitis
Plaque, Dental

Browse trials for

Keywords

Loe and Silness Gingival Index
Quigley and Hein Plaque Index

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 80 is above the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Colgate Palmolive is the lead sponsor of 114 studies on the registry; 12 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.

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

Who can participate

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

Inclusion criteria

Potential subjects must meet all of the following criteria
Subjects, ages 18-70, inclusive
Availability for the six-month duration of the clinical research study
Good general health
Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index
Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index
Signed Informed Consent Form

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.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 80 participants (actual)

Study arms

Experimental
Group I
toothpaste brushing 2x daily morning \& evening for 2 minutes
Drug: Test · Drug: Control
Active comparator
Group II
toothpaste brushing 2x daily morning \& evening for 2 minutes
Drug: Test · Drug: Control

Interventions

DrugTest
test toothpaste containing 0.45% stannous fluoride
DrugControl
toothpaste containing 0.76% sodium monofluorophosphate

What researchers measure

Primary outcomes

Whole-Mouth Gingivitis Measurement
difference of reduction in gingival index
Time frame: baseline, 3 months and 6 months
Whole-Mouth Dental Plaque Measurement
difference of reduction in plaque index
Time frame: baseline, 3 months and 6 months

Study locations

1 site

Loma Linda University School of Dentistry
Loma Linda, California 92350, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06300866
Lead sponsor: Colgate Palmolive
Responsible party: Sponsor
First posted: Mar 8, 2024
Start date: Aug 18, 2020
Primary completion: Mar 8, 2021
Completion: Mar 8, 2021
Last update: Mar 8, 2024

Study contacts

Yiming Li, DDS MSD PhD

principal investigator · Loma Linda University

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 Mar 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Gingivitis→

Other studies from this sponsor

Colgate Palmolive

Start the discussion