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

• ClinicalTrials.gov Identifier: NCT04626778
• Recruitment Status: Completed
• First Posted: November 13, 2020
• Last Update Posted: January 20, 2021
• Sponsor: Colgate Palmolive
• Information provided by (Responsible Party): Colgate Palmolive

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Peroxyl Mouthwash; Drug: Placebo Mouthwash	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Each subject will be randomized to receive one of the two possible study products.
• Masking: Double (Participant, Investigator)
• Masking Description: A blinded randomized controlled parallel group design trial
• Primary Purpose: Treatment
• Official Title: Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination Phase I
• Actual Study Start Date: October 8, 2020
• Actual Primary Completion Date: December 15, 2020
• Actual Study Completion Date: December 15, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Peroxyl; 1.5% Hydrogen Peroxide mouthwash	Drug: Peroxyl Mouthwash; Mouthwash; Other Name: 1.5% HP
Placebo Comparator: placebo mouthwash; 0.0% Hydrogen peroxide mouthwash	Drug: Placebo Mouthwash; Mouthwash; Other Name: 0.0% HP Mouthwash

Outcome Measures

Primary Outcome Measures :

1. Change in the Colony Forming Unit of total bacteria in saliva and in bioaerosol [ Time Frame: baseline, 30 minutes & 60 minutes ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, California

Loma Linda University School of Dentistry, Center for Dental Research

Loma Linda, California, United States, 92350

Sponsors and Collaborators

Colgate Palmolive

Investigators

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

More Information

• Responsible Party: Colgate Palmolive
• ClinicalTrials.gov Identifier: NCT04626778
• Other Study ID Numbers: CRO-2020-08-BAC-HP-CA-BGS
• First Posted: November 13, 2020
• Last Update Posted: January 20, 2021
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All IPD that underlie results in a publication
• Supporting Materials: Study Protocol
• Time Frame: after analysis is completed

• 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

Keywords provided by Colgate Palmolive:

Mouthwash; Saliva; Bioaerosol; Bacteria; Gingivitis

Additional relevant MeSH terms:

Hydrogen Peroxide; Anti-Infective Agents, Local; Anti-Infective Agents