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

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

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)

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Peroxyl Mouthwash; Drug: Placebo Mouthwash

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University School of Dentistry, Center for Dental Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peroxyl; 1.5% Hydrogen Peroxide mouthwash	Drug: Peroxyl Mouthwash; Mouthwash; Other Names: 1.5% HP
Placebo Comparator: placebo mouthwash; 0.0% Hydrogen peroxide mouthwash	Drug: Placebo Mouthwash; Mouthwash; Other Names: 0.0% HP Mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Yiming Li, DDS/PhD/MSD, Loma Linda University School of Dentistry, Center for Dental Research

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Bacteria; Saliva; Mouthwash; Gingivitis; Bioaerosol
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: CRO-2020-08-BAC-HP-CA-BGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: after analysis is completed
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes