A Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

NCT06140771 — Not applicable, Completed, 115 participants, Procter and Gamble

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A Three-Month Clinical Study to Assess the Gingivitis Effects of Various Dentifrices

RegistryNCT06140771
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment115 (Actual)
SponsorProcter and Gamble (Industry)
ConditionsGingivitis
Interventions0.76% Sodium Monofluorophosphate Dentifrice, 1.15% Sodium Monofluorophosphate Dentifrice, 0.454% Stannous Fluoride Dentifrice (Drug)
Datesstart 2021-10-20, primary completion 2022-02-06, completion 2022-02-06, first posted 2023-11-20, last updated 2023-11-20
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Gingivitis All trials of 0.76% Sodium Monofluorophosphate Dentifrice All trials of 1.15% Sodium Monofluorophosphate Dentifrice

-Summary

The objective of this learning clinical study is to assess the gingivitis effects of four different dentifrices over a 3-month period.

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+Arms and interventions

ArmTypeInterventionsDescription
0.76% Sodium Monofluorophosphate DentifriceSham comparatorDrug: 0.76% Sodium Monofluorophosphate Dentifrice
1.15% Sodium Monofluorophosphate DentifriceSham comparatorDrug: 1.15% Sodium Monofluorophosphate Dentifrice
Marketed 0.454% Stannous Fluoride DentifriceActive comparatorDrug: 0.454% Stannous Fluoride Dentifrice
0.454% Stannous Fluoride DentifriceActive comparatorDrug: 0.454% Stannous Fluoride Dentifrice
  • 0.76% Sodium Monofluorophosphate Dentifrice (Drug): Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
  • 1.15% Sodium Monofluorophosphate Dentifrice (Drug): Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
  • 0.454% Stannous Fluoride Dentifrice (Drug): Whole mouth brushing with a toothpaste, twice daily for the duration of the study.
  • 0.454% Stannous Fluoride Dentifrice (Drug): Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

+Outcome measures

Primary outcomes

  • Löe-Silness Gingivitis Evaluation [3 Months]: 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 outcomes

  • 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).
  • Löe-Silness Gingivitis Evaluation [1 Month]: 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

Sex: All, ages: 18 Years to any, accepts 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;
* Have mild to moderate gingivitis with a range of 10% to 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 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.

+Locations (1)

FacilityCityCountryStatus
UHRGWhittier, CaliforniaUnited States