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

NCT04626778 | Completed Phase 2 FDA Drug

• 1 other identifier: CRO-2020-08-BAC-HP-CA-BGS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Healthy

Keywords

Mouthwash; Saliva; Bioaerosol; Bacteria; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Change in the Colony Forming Unit of total bacteria in saliva and in bioaerosol

  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.

  baseline, 30 minutes & 60 minutes

Study Arms (2)

Peroxyl

ACTIVE COMPARATOR

1.5% Hydrogen Peroxide mouthwash

Drug: Peroxyl Mouthwash

placebo mouthwash

PLACEBO COMPARATOR

0.0% Hydrogen peroxide mouthwash

Drug: Placebo Mouthwash

Interventions

Peroxyl Mouthwash DRUG

Mouthwash

Also known as: 1.5% HP

Peroxyl

Placebo Mouthwash DRUG

Mouthwash

Also known as: 0.0% HP Mouthwash

placebo mouthwash

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Loma Linda University School of Dentistry, Center for Dental Research

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Yiming Li, DDS/PhD/MSD

  Loma Linda University School of Dentistry, Center for Dental Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A blinded randomized controlled parallel group design trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 13, 2020
• Study Start: October 8, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: January 20, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after analysis is completed

Locations

US (1)