Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

NCT04794439 | Completed Phase 2 FDA Drug

• 1 other identifier: ST-20-U81
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate and compare plaque removal efficacy of four dentifrices following a single timed tooth brushing. Prior to each evaluation visit of the four-way cross-over study, subjects will abstain from all oral hygiene for 24 hours. At each evaluation visit, subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.

Conditions

Plaque, Dental

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.

  plaque evaluation

  up to 4 weeks

Study Arms (4)

Toothpaste 1 with Stannous Fluoride

ACTIVE COMPARATOR

Toothpaste with Stannous Fluoride

Drug: Dentifrices

Toothpaste 1 with Sodium Fluoride and sodium bicarbonate

ACTIVE COMPARATOR

Toothpaste with Sodium Fluoride and sodium bicarbonate

Drug: Dentifrices

Toothpaste 2 with Stannous Fluoride

ACTIVE COMPARATOR

Toothpaste with Stannous Fluoride

Drug: Dentifrices

Toothpaste 2 with sodium Fluoride and sodium bicarbonate

ACTIVE COMPARATOR

Toothpaste with sodium Fluoride and sodium bicarbonate

Drug: Dentifrices

Interventions

Dentifrices DRUG

Dentifrice on plaque

Toothpaste 1 with Sodium Fluoride and sodium bicarbonate; Toothpaste 1 with Stannous Fluoride; Toothpaste 2 with Stannous Fluoride; Toothpaste 2 with sodium Fluoride and sodium bicarbonate

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 18 to 69 years

You may not qualify if:

• Have any known allergies or sensitivities to marketed dentifrice or oral hygiene products.
• Have fixed or removable orthodontic appliances, peri/oral piercings, or removable partial dentures.
• Evidence of poor oral hygiene, rampant dental caries, presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Dentifrices

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: March 12, 2021
• Study Start: November 16, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)