Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste

NCT06300866 | Completed Phase 3 FDA Drug

• 1 other identifier: CRO-2020-04-PGN-LLU-YPZ
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis; Plaque, Dental

Keywords

Loe and Silness Gingival Index; Quigley and Hein Plaque Index

Outcome Measures

Primary Outcomes (2)

• Whole-Mouth Gingivitis Measurement

  difference of reduction in gingival index

  baseline, 3 months and 6 months

• Whole-Mouth Dental Plaque Measurement

  difference of reduction in plaque index

  baseline, 3 months and 6 months

Study Arms (2)

Group I

EXPERIMENTAL

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

Drug: Test; Drug: Control

Group II

ACTIVE COMPARATOR

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

Drug: Test; Drug: Control

Interventions

Test DRUG

test toothpaste containing 0.45% stannous fluoride

Group I; Group II

Control DRUG

toothpaste containing 0.76% sodium monofluorophosphate

Group I; Group II

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Presence of orthodontic appliances
• Presence of partial removable dentures
• Tumor(s) of the soft or hard tissues of the oral cavity
• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Loma Linda University School of Dentistry

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Condition Hierarchy (Ancestors)

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

Study Officials

• Yiming Li, DDS MSD PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 8, 2024
• Study Start: August 18, 2020
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2021
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)