Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste (CP_Total)

Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Three Month Study

The objective of this study is to evaluate the clinical efficacy of a toothpaste containing stannous fluoride as compared to Colgate Fluoride Toothpaste in reducing plaque and gingivitis - a three- month study.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Colgate Cavity Protection toothpaste; Drug: Colgate Total SF

Detailed Description

This was a 6-month, randomized, single-center, parallel group, double-blinded, clinical research study to assess the clinical efficacy of two toothpastes containing stannous fluoride (SnHW and CPH) as compared to Regular Fluoride Toothpaste on the reduction of established dental plaque and gingivitis in adults.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Melbourne, Florida, United States, 32940
      • Consumer Research Consulting, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects, ages 18-70, inclusive.
• Availability for the six-month duration ofthe clinical research study.
• Good general health.
• Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
• Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
• Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein °Plaque Index (Turesky Modification).
• Signed Informed Consent Form.

Exclusion Criteria:

• Presence of partial denture.
• Presence of partial removable dentures.
• Tumor(s) of the soft or hard tissues of the oral cavity.
• Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
• Five or more carious lesions requiring immediate restorative treatment.
• Antibiotic use any time during the one month 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 which prohibits eating or drinking for periods up to 4 hours.
• History of alcohol or drug abuse.
• Pregnant or lactating subjects.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Fluoride Control; Colgate Cavity Protection 0.76% as Na MFP Toothpaste	Drug: Colgate Cavity Protection toothpaste; 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.; Other Names: CDC
Active Comparator: Colgate Total SF; Colgate Total Clean Mint White Paste 1100 ppm F Toothpaste	Drug: Colgate Total SF; 1100 ppm F Colgate Total Clean Mint White Paste Toothpaste is a test treatment; Other Names: Stannous Fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingivitis Scores	Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)	Baseline
Gingivitis Scores	Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)	3 months
Dental Plaque Score	Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)	Baseline
Dental Plaque Score	Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)	3 months

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Study Director: Yun Po Zhang, Doctoral, Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 24, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride; Tin Fluorides
• Other Study ID Numbers: CRO-2019-03-PG-SNF-FL-BGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No