Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing
Primary Purpose
Plaque, Dental
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dentifrices
Sponsored by
About this trial
This is an interventional treatment trial for Plaque, Dental
Eligibility Criteria
Inclusion Criteria:
1) 18 to 69 years
Exclusion Criteria:
- 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.
Sites / Locations
- Salus Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Toothpaste 1 with Stannous Fluoride
Toothpaste 1 with Sodium Fluoride and sodium bicarbonate
Toothpaste 2 with Stannous Fluoride
Toothpaste 2 with sodium Fluoride and sodium bicarbonate
Arm Description
Toothpaste with Stannous Fluoride
Toothpaste with Sodium Fluoride and sodium bicarbonate
Toothpaste with Stannous Fluoride
Toothpaste with sodium Fluoride and sodium bicarbonate
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04794439
First Posted
February 14, 2021
Last Updated
March 10, 2021
Sponsor
Church & Dwight Company, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04794439
Brief Title
Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing
Official Title
Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
December 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Church & Dwight Company, Inc.
4. Oversight
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.
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study is a randomized, single-brushing, examiner-blinded, 4-cell cross-over design that enrolled approximately 70 subjects to ensure that at least 60 subjects to complete the study. This 4-week cross-over study will evaluate plaque removal following a single brushing with the assigned dentifrices. Qualified subjects will have sufficient plaque (Lobene-Soparkar Modification of Turesky Plaque Index). Subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Dental
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toothpaste 1 with Stannous Fluoride
Arm Type
Active Comparator
Arm Description
Toothpaste with Stannous Fluoride
Arm Title
Toothpaste 1 with Sodium Fluoride and sodium bicarbonate
Arm Type
Active Comparator
Arm Description
Toothpaste with Sodium Fluoride and sodium bicarbonate
Arm Title
Toothpaste 2 with Stannous Fluoride
Arm Type
Active Comparator
Arm Description
Toothpaste with Stannous Fluoride
Arm Title
Toothpaste 2 with sodium Fluoride and sodium bicarbonate
Arm Type
Active Comparator
Arm Description
Toothpaste with sodium Fluoride and sodium bicarbonate
Intervention Type
Drug
Intervention Name(s)
Dentifrices
Intervention Description
Dentifrice on plaque
Primary Outcome Measure Information:
Title
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.
Description
plaque evaluation
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1) 18 to 69 years
Exclusion Criteria:
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.
Facility Information:
Facility Name
Salus Research, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing
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