The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis

NCT03852056 | Completed Phase 3

• 1 other identifier: CRO-2017-02-GIN-SNDZ-YPZ
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the clinical efficacy of a new toothpaste containing stannous fluoride (SnF) as compared to Colgate Fluoride Toothpaste in reducing gingivitis and dental plaque.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (6)

• Dental Plaque Scores

  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 Scores

  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 month

• Dental Plaque Scores

  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)

  6 month

• Gingivitis Scores

  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

  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

• Gingivitis Scores

  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)

  6 months

Study Arms (2)

MFP Fluoride toothpaste

PLACEBO COMPARATOR

Commercially available, monofluorophosphate (MFP) toothpaste. Fluoride level is 0.76%

Drug: MFP Fluoride toothpaste

Stannous Fluoride Toothpaste

EXPERIMENTAL

New toothpaste containing 0.454% stannous fluoride.

Drug: Stannous fluoride toothpaste

Interventions

MFP Fluoride toothpaste DRUG

Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,

Also known as: Colgate Great Regular Flavor toothpaste

MFP Fluoride toothpaste

Stannous fluoride toothpaste DRUG

Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,

Stannous Fluoride Toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, ages 18-70, inclusive.
• Availability for the six-month duration of the 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.

You may not qualify if:

• Presence of orthodontic bands.
• 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 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 or drinking for periods up to 4 hours.
• History of alcohol or drug abuse.
• Self-reported pregnant or lactating subjects.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

West China Dental Institute of Chengdu

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All clinical product will be in a plain white toothpaste tube or over wrapped with white laminate material to conceal any product identity. All study treatments will have a clinical label attached that contains study information and a unique product code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Tooth brushing study. Subjects brush their whole mouth 2x/day for 1 minute each time. The study duration is 6 months

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 22, 2019
• Study Start: May 25, 2017
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: February 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)