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

Sponsor
Colgate Palmolive (Industry)
Overall Status
Completed
CT.gov ID
NCT04717063
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
1.7
Actual Duration (Months)
58.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Peroxyl Oral Product
  • Drug: Placebo
 Phase 2

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 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 productsEach subject will be randomized to receive one of the two possible study products
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Triple (Participant, Investigator, Outcome Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination Phase 2
Actual Study Start Date :
Nov 16, 2020
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Jan 7, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Peroxyl

Drug: Peroxyl Mouthwash Mouthwash Other Names: • 1.5% HP

Drug: Peroxyl Oral Product
mouth wash
Other Names:
  • Peroxyl Mouth wash

    		•
    Placebo Comparator: placebo mouthwash

    Drug: Placebo Mouthwash Mouthwash Other Names: • 0.0% HP Mouthwash

    Drug: Placebo
    placebo mouth wash

    Outcome Measures

    Primary Outcome Measures

    1. 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

    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 Loma Linda California United States 92350

    Sponsors and Collaborators

    • Colgate Palmolive

    Investigators

    • Principal Investigator: Yiming Li, DDS MSD PhD, Loma Linda University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Colgate Palmolive
    ClinicalTrials.gov Identifier:
    NCT04717063
    Other Study ID Numbers:
    • CRO-2020-08-BAC-HP-CA-BGS2
    First Posted:
    Jan 20, 2021
    Last Update Posted:
    Jan 20, 2021
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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