Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Plaque, Dental; Gingivitis

Treatments: Drug: Control; Drug: Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT06300866

CRO-2020-04-PGN-LLU-YPZ

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group I

Experimental group

Description:

toothpaste brushing 2x daily morning \& evening for 2 minutes

Treatment:

Drug: Control

Drug: Test

Group II

Active Comparator group

Description:

toothpaste brushing 2x daily morning \& evening for 2 minutes

Treatment:

Drug: Control

Drug: Test