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

NCT04717063 | Completed Phase 2 FDA Drug

• 1 other identifier: CRO-2020-08-BAC-HP-CA-BGS2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Mouthwash; Saliva; Bioaerosol; Bacteria; Gingivitis

Outcome Measures

Primary Outcomes (1)

• evaluate the antibacterial efficacy of mouthwash in reducing the levels of bacteria in bioaerosols generated by dental prophylaxis

  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

  30 min

Study Arms (2)

Peroxyl

ACTIVE COMPARATOR

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

Drug: Peroxyl Oral Product

placebo mouthwash

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Peroxyl Oral Product DRUG

mouth wash

Also known as: Peroxyl Mouth wash

Peroxyl

Placebo DRUG

placebo mouth wash

placebo mouthwash

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Yiming Li, DDS MSD PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcome Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject will be randomized to receive one of the two possible study products

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 20, 2021
• Study Start: November 16, 2020
• Primary Completion: December 30, 2020
• Study Completion: January 7, 2021
• Last Updated: January 20, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)