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

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

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-25

Study Completion Date

2018-06-03

Brief Summary

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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.

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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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Marketed Stannous Fluoride Paste

Brush twice daily

Group Type EXPERIMENTAL

Marketed toothpaste

Intervention Type DRUG

Marketed stannous fluoride (0.454%) toothpaste

Marketed Cavity Protection Toothpaste

Brush twice daily

Group Type PLACEBO_COMPARATOR

Marketed Cavity Protection Toothpaste

Intervention Type DRUG

Marketed sodium monofluorophosphate (0.76 %) toothpaste

Interventions

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Marketed toothpaste

Marketed stannous fluoride (0.454%) toothpaste

Intervention Type DRUG

Marketed Cavity Protection Toothpaste

Marketed sodium monofluorophosphate (0.76 %) toothpaste

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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes