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OpenTrials
Completed

NCT Number: NCT06300866

Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Loma Linda University School of Dentistry

Loma Linda, California, 92350, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test

Drug

test toothpaste containing 0.45% stannous fluoride

Control

Drug

toothpaste containing 0.76% sodium monofluorophosphate

Primary outcomes

  1. Whole-Mouth Gingivitis Measurement

    Time frame: baseline, 3 months and 6 months

    difference of reduction in gingival index

  2. Whole-Mouth Dental Plaque Measurement

    Time frame: baseline, 3 months and 6 months

    difference of reduction in plaque index

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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