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

Sponsor
Colgate Palmolive (Industry)
Overall Status
Completed
CT.gov ID
NCT04626778
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
2.2
Actual Duration (Months)
44.8
Patients Per Site Per Month

Study Details

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
  • 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
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.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 :
Oct 8, 2020
Actual Primary Completion Date :
Dec 15, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Colgate Palmolive
    ClinicalTrials.gov Identifier:
    NCT04626778
    Other Study ID Numbers:
    • CRO-2020-08-BAC-HP-CA-BGS
    First Posted:
    Nov 13, 2020
    Last Update Posted:
    Jan 20, 2021
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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

    Study Results

    No Results Posted as of Jan 20, 2021