Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria Saliva and Bioaerosol Contamination Phase 2

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

2020-11-16

Study Completion Date

2021-01-07

Brief Summary

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To evaluate the antibacterial efficacy of a commercial mouthwash containing 1.5% hydrogen peroxide in reducing the levels of bacteria in bioaerosols generated by dental prophylaxis.

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Detailed Description

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Following a washout period, subjects will return to the clinical site. A baseline microbial sample will be collected from the operatory's atmosphere for 30 min. prior to the study subject appointment by placing blood agar plates on a support board attached to the bracket chair tray. Upon completion of a half-mouth (e.g. right side) dental prophylaxis, each study subject will be instructed to rinse for one minute with 10 ml of one of the two mouthwash solutions (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) and to expectorate all remaining liquid. Next, the dental prophylaxis will be completed on the other side of the mouth. Bioaerosol samples will be collected prior to and following rinsing on blood agar plates placed on a support board at a 50-degree angle to the participant's chest, on the participant's chest, and on the examiner's forehead. Plates will be closed and labeled. The plates will be transferred to the microbiology laboratory for analysis. All subjects will be followed for adverse events throughout the study.

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

TRIPLE

Participants Investigators Outcome Assessors

Triple (Participant, Investigator, Outcome Assessor)

Study Groups

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Peroxyl

Drug: Peroxyl Mouthwash Mouthwash

Other Names:

• 1.5% HP

Group Type ACTIVE_COMPARATOR

Peroxyl Oral Product

Intervention Type DRUG

mouth wash

placebo mouthwash

Drug: Placebo Mouthwash Mouthwash

Other Names:

• 0.0% HP Mouthwash

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo mouth wash

Interventions

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Peroxyl Oral Product

mouth wash

Intervention Type DRUG

Placebo

placebo mouth wash

Intervention Type DRUG

Other Intervention Names

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Peroxyl Mouth wash

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