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A Three Month Bleeding-Model Clinical Study

Sponsor
Procter and Gamble (Industry)
Overall Status
Completed
CT.gov ID
NCT05916521
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
2.9
Actual Duration (Months)
31.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.454% stannous fluoride
  • Drug: 0.76% sodium monofluorophosphate
  • Drug: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Three-Month Bleeding-Model Clinical Study
Actual Study Start Date :
Nov 15, 2021
Actual Primary Completion Date :
Feb 11, 2022
Actual Study Completion Date :
Feb 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Positive Control

2 brushings per day (AM and PM)

Drug: 0.454% stannous fluoride
Brush two times daily
Sham Comparator: Negative Control

2 brushings per day (AM and PM)

Drug: 0.76% sodium monofluorophosphate
Brush two times daily
Experimental: Experimental Control

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

Drug: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM
Brush two times daily

Outcome Measures

Primary Outcome Measures

  1. Löe-Silness Gingivitis Evaluation [Baseline]

    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).

  2. Löe-Silness Gingivitis Evaluation [Week 4]

    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).

  3. Löe-Silness Gingivitis Evaluation [Week 12]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Silverstone Research Group Las Vegas Nevada United States 89146

Sponsors and Collaborators

  • Procter and Gamble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT05916521
Other Study ID Numbers:
  • 2021086
First Posted:
Jun 23, 2023
Last Update Posted:
Jun 23, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gingivitis
Fluorides
Tin Fluorides
Fluorophosphate

Study Results

No Results Posted as of Jun 23, 2023