Clinical trial NCT04626778: Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination
Official title: Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Mouthwash
Saliva
Bioaerosol
Bacteria
Gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2020-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject will be randomized to receive one of the two possible study products.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in the Colony Forming Unit of total bacteria in saliva and in bioaerosol
timeFrame: baseline, 30 minutes & 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Dentistry, Center for Dental Research
state: California
Study officials:
affiliation: Loma Linda University School of Dentistry, Center for Dental Research
name: Yiming Li, DDS/PhD/MSD
role: PRINCIPAL_INVESTIGATOR
References: