Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste

Gingivitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06300866
• Other study ID #: CRO-2020-04-PGN-LLU-YPZ
• Status: Completed
• Phase: Phase 3
• Start date: August 18, 2020
• Est. completion date: March 8, 2021

Study information

• Verified date: March 2024
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis
• Plaque, Dental

Intervention

Drug:
• Test
test toothpaste containing 0.45% stannous fluoride
• Control
toothpaste containing 0.76% sodium monofluorophosphate

Locations

Country	Name	City	State
United States	Loma Linda University School of Dentistry	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

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