Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste

The Clinical Investigation of Stannous Fluoride Containing Toothpaste Compared to Colgate Cavity Protection Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in California

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06300866

Enrollment

Registered

2024-03-08

Start date

2020-08-18

Completion date

2021-03-08

Last updated

2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Plaque, Dental

Keywords

Loe and Silness Gingival Index, Quigley and Hein Plaque Index

Brief 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.

Interventions

DRUGTest

test toothpaste containing 0.45% stannous fluoride

DRUGControl

toothpaste containing 0.76% sodium monofluorophosphate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

* 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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026