Clinical Efficacy of Single-Use of Peroxyl Mouthwash for... | NCT04626778

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

NCT04626778

Sponsor

Colgate Palmolive

Status

Completed

Last Update Posted

Jan 20, 2021Actual

Enrollment

100Actual

Phase

Phase 2

Conditions

Healthy

Interventions

Peroxyl Mouthwash
Placebo Mouthwash

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2020Actual

Primary Completion Date

Dec 15, 2020Actual

Completion Date

Dec 15, 2020Actual

First Submitted Date

Nov 5, 2020

First Submission Date that Met QC Criteria

Nov 11, 2020

First Posted Date

Nov 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2021

Last Update Posted Date

Jan 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Peroxyl	Active Comparator	1.5% Hydrogen Peroxide mouthwash	Drug: Peroxyl Mouthwash
placebo mouthwash	Placebo Comparator	0.0% Hydrogen peroxide mouthwash	Drug: Placebo Mouthwash

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peroxyl Mouthwash	Drug	Mouthwash	Peroxyl	1.5% HP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the Colony Forming Unit of total bacteria in saliva and in bioaerosol	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.	baseline, 30 minutes & 60 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yiming Li, DDS/PhD/MSD	Loma Linda University School of Dentistry, Center for Dental Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda University School of Dentistry, Center for Dental Research		Loma Linda	California	92350	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All IPD that underlie results in a publication

Types

Study Protocol

Time Frame

after analysis is completed

Access Criteria

Not provided

URL

Not provided

ID	Term
D007239	Infections
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases