A Bleeding-Model Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2020-11-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Positive Control

2 brushings per day (AM and PM)

Group Type ACTIVE_COMPARATOR

0.454% stannous fluoride

Intervention Type DRUG

Brush two times daily

Negative Control

2 brushings per day (AM and PM)

Group Type SHAM_COMPARATOR

0.76% sodium monofluorophosphate

Intervention Type DRUG

Brush two times daily

Experimental Control

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

Group Type EXPERIMENTAL

0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM

Intervention Type DRUG

Brush two times daily

Interventions

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0.454% stannous fluoride

Brush two times daily

Intervention Type DRUG

0.76% sodium monofluorophosphate

Brush two times daily

Intervention Type DRUG

0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM

Brush two times daily

Intervention Type DRUG

Eligibility Criteria

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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 % 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes