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A Three Month Bleeding-Model Clinical Study

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
0.454% stannous fluoride
0.76% sodium monofluorophosphate
0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM
Sponsored by
Procter and Gamble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Be at least 18 years of age; Provide written informed consent prior to participation and be given a signed copy of the informed consent form; Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial; Have at least 20 gradable teeth; Have established gingivitis with 10-70% bleeding sites; Agree to return for scheduled visits and follow the study procedures; Agree to refrain from use of any non-study oral hygiene products for the duration of the study; Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study. Exclusion Criteria: Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit; Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; Having known hypersensitivity to the test products; Having removable oral appliances; Having fixed facial or lingual orthodontic appliances; Self-reported pregnancy or lactation; Having any diseases or condition that might interfere with the safe participation in the study; Having an inability to undergo study procedures.

Sites / Locations

  • Silverstone Research Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Experimental

Arm Label

Positive Control

Negative Control

Experimental Control

Arm Description

2 brushings per day (AM and PM)

2 brushings per day (AM and PM)

Brush with Positive control in the morning and negative control in the evening

Outcomes

Primary Outcome Measures

Löe-Silness Gingivitis Evaluation
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Löe-Silness Gingivitis Evaluation
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Löe-Silness Gingivitis Evaluation
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT05916521
Brief Title
A Three Month Bleeding-Model Clinical Study
Official Title
A Three-Month Bleeding-Model Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
February 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Control
Arm Type
Active Comparator
Arm Description
2 brushings per day (AM and PM)
Arm Title
Negative Control
Arm Type
Sham Comparator
Arm Description
2 brushings per day (AM and PM)
Arm Title
Experimental Control
Arm Type
Experimental
Arm Description
Brush with Positive control in the morning and negative control in the evening
Intervention Type
Drug
Intervention Name(s)
0.454% stannous fluoride
Intervention Description
Brush two times daily
Intervention Type
Drug
Intervention Name(s)
0.76% sodium monofluorophosphate
Intervention Description
Brush two times daily
Intervention Type
Drug
Intervention Name(s)
0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM
Intervention Description
Brush two times daily
Primary Outcome Measure Information:
Title
Löe-Silness Gingivitis Evaluation
Description
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Time Frame
Baseline
Title
Löe-Silness Gingivitis Evaluation
Description
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Time Frame
Week 4
Title
Löe-Silness Gingivitis Evaluation
Description
Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be at least 18 years of age; Provide written informed consent prior to participation and be given a signed copy of the informed consent form; Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial; Have at least 20 gradable teeth; Have established gingivitis with 10-70% bleeding sites; Agree to return for scheduled visits and follow the study procedures; Agree to refrain from use of any non-study oral hygiene products for the duration of the study; Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study. Exclusion Criteria: Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit; Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; Having known hypersensitivity to the test products; Having removable oral appliances; Having fixed facial or lingual orthodontic appliances; Self-reported pregnancy or lactation; Having any diseases or condition that might interfere with the safe participation in the study; Having an inability to undergo study procedures.
Facility Information:
Facility Name
Silverstone Research Group
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States

12. IPD Sharing Statement

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A Three Month Bleeding-Model Clinical Study

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