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A Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice

Primary Purpose

Gingivitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Marketed Toothpaste
Marketed Cavity Protection Toothpaste
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 16 gradable teeth;
  • 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 antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
  • Have 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;
  • Removable oral appliances;
  • Fixed facial or lingual orthodontic appliances;
  • Self-reported pregnancy or lactation;
  • Any diseases or condition that might interfere with the safe participation in the study; and
  • Inability to undergo study procedures.

Sites / Locations

  • Silverstone Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Marketed Stannous Fluoride Toothpaste

Marketed Cavity Protection Toothpaste

Arm Description

Brush twice daily

Brush twice daily

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

Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).
Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).
Turesky Modified Quigley-Hein Index
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).

Full Information

First Posted
May 1, 2019
Last Updated
June 7, 2023
Sponsor
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT03936569
Brief Title
A Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice
Official Title
A 3-Month Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
January 25, 2019 (Actual)
Study Completion Date
January 25, 2019 (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
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.

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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Marketed Stannous Fluoride Toothpaste
Arm Type
Experimental
Arm Description
Brush twice daily
Arm Title
Marketed Cavity Protection Toothpaste
Arm Type
Placebo Comparator
Arm Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Marketed Toothpaste
Intervention Description
Marketed stannous fluoride (0.454%) toothpaste
Intervention Type
Drug
Intervention Name(s)
Marketed Cavity Protection Toothpaste
Intervention Description
Marketed sodium monofluorophosphate (0.76 %) toothpaste
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
1 Month
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
3 Months
Secondary Outcome Measure Information:
Title
Turesky Modified Quigley-Hein Index
Description
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).
Time Frame
Baseline
Title
Turesky Modified Quigley-Hein Index
Description
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).
Time Frame
1 Month
Title
Turesky Modified Quigley-Hein Index
Description
The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).
Time Frame
3 Months

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 16 gradable teeth; 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 antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit; Have 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; Removable oral appliances; Fixed facial or lingual orthodontic appliances; Self-reported pregnancy or lactation; Any diseases or condition that might interfere with the safe participation in the study; and 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

Learn more about this trial

A Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice

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