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

NCT ID: NCT04033575

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2019-07-01

Brief Summary

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.

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.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fluoride Control

Colgate Cavity Protection 0.76% as Na MFP Toothpaste

Group Type: SHAM_COMPARATOR

Colgate Cavity Protection toothpaste

Intervention Type: DRUG

0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.

Colgate Total SF

Colgate Total Clean Mint White Paste 1100 ppm F Toothpaste

Group Type: ACTIVE_COMPARATOR

Colgate Total SF

Intervention Type: DRUG

1100 ppm F Colgate Total Clean Mint White Paste Toothpaste is a test treatment

Interventions

Colgate Total SF

1100 ppm F Colgate Total Clean Mint White Paste Toothpaste is a test treatment

Intervention Type: DRUG

Colgate Cavity Protection toothpaste

0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.

Intervention Type: DRUG

Other Intervention Names

Stannous Fluoride; CDC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yun Po Zhang, Doctoral

Role: STUDY_DIRECTOR

Colgate Palmolive

Locations

Consumer Research Consulting, LLC

Melbourne, Florida, United States

Countries

United States

Other Identifiers

CRO-2019-03-PG-SNF-FL-BGS

Identifier Type: -

Identifier Source: org_study_id