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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: Peroxyl Oral Product; Drug: Placebo

• Registration Number: NCT04717063
• Lead Sponsor: Colgate Palmolive

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11-16
• Primary Completion: 2020-12-30
• Study Completion: 2021-01-07
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Last Update Submitted: 2021-01-19
• Study First Posted: 2021-01-20
• 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 Oral Product	Drug: Peroxyl Mouthwash Mouthwash Other Names: • 1.5% HP
placebo mouthwash	Placebo	Drug: Placebo Mouthwash Mouthwash Other Names: • 0.0% HP Mouthwash

Primary Outcome Measures

Name	Time	Method
evaluate the antibacterial efficacy of mouthwash in reducing the levels of bacteria in bioaerosols generated by dental prophylaxis	30 min	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

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States