Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination

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

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2020-12-15

Brief Summary

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To evaluate the anti-bacterial, pre-procedural, clinical efficacy of Peroxyl mouthwash (1.5% hydrogen peroxide) in saliva and the reduction of bioaerosol contamination as compared to a matching placebo mouthwash (0.0% hydrogen peroxide)

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Detailed Description

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Qualified subjects will be enrolled and randomized to either one of the two study groups, balanced on the basis of their initial gingival index scores. Saliva samples will be collected from participants prior to rinsing with their assigned mouthwash (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) for one minute and then expectorate. Saliva samples will again be collected immediately after, at 30 min, and 60 min after rinsing. All collected saliva samples will be placed in sterile vials, labeled with subject information and transferred to the microbiology laboratory for analysis.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each subject will be randomized to receive one of the two possible study products.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

A blinded randomized controlled parallel group design trial

Study Groups

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Peroxyl

1.5% Hydrogen Peroxide mouthwash

Group Type ACTIVE_COMPARATOR

Peroxyl Mouthwash

Intervention Type DRUG

Mouthwash

placebo mouthwash

0.0% Hydrogen peroxide mouthwash

Group Type PLACEBO_COMPARATOR

Placebo Mouthwash

Intervention Type DRUG

Mouthwash

Interventions

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Peroxyl Mouthwash

Mouthwash

Intervention Type DRUG

Placebo Mouthwash

Mouthwash

Intervention Type DRUG

Other Intervention Names

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1.5% HP 0.0% HP Mouthwash

Eligibility Criteria

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Inclusion Criteria

* Potential subjects must meet ALL of the following criteria:

* Subjects, ages 18-70, inclusive.
* Availability for the duration of this clinical research study.
* Good general health.
* At least 20 natural teeth.
* Gingivitis Index 1.0 (Löe-Silness).
* Signed Informed Consent Form

Exclusion Criteria

* Potential subjects must NOT HAVE ANY of the following conditions:

* Symptoms consistent with COVID-19 or have tested positive.
* Presence of orthodontic bands.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) or peri-implantitis.
* Five or more carious lesions requiring immediate restorative treatment.
* Use of antibiotic one-month prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits not eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Self-reported pregnant or lactating subjects.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes