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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: Peroxyl Mouthwash; Drug: Placebo Mouthwash

• Registration Number: NCT04626778
• Lead Sponsor: Colgate Palmolive

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)

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 Timeline

• Study Start: 2020-10-08
• Status Verified: 2020-11
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-13
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peroxyl	Peroxyl Mouthwash	1.5% Hydrogen Peroxide mouthwash
placebo mouthwash	Placebo Mouthwash	0.0% Hydrogen peroxide mouthwash

Primary Outcome Measures

Name	Time	Method
Change in the Colony Forming Unit of total bacteria in saliva and in bioaerosol	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.

Trial Locations

Locations (1)

Loma Linda University School of Dentistry, Center for Dental Research; 🇺🇸 Loma Linda, California, United States