NCT04719208

Brief Summary

The purpose of this study is to test the effectiveness of prophylactic mouth rinses in reducing the amount of viruses, specifically SARS-CoV-2 in the oral cavity. This research will guide dental and medical providers on best practices to be performed prior to dental and medical procedures involving the oral cavity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

2.7 years

First QC Date

October 21, 2020

Last Update Submit

January 31, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • Change in oral SARS-CoV-2 load in oral cavity of COVID-19 patient using prophylactic mouth rinse

    up to 2 hours post-rinse with mouthwash.

Study Arms (5)

Chlorhexidine gluconate (A)

EXPERIMENTAL

Mouth rinse with 0.2% Chlorhexidine gluconate,

Other: Chlorhexidine gluconate (A) Mouth rinse with the solution provided

Hydrogen peroxide (B)

EXPERIMENTAL

Mouth rinse with 1.5% hydrogen peroxide

Other: Hydrogen peroxide (B) Mouth rinse with the solution provided

Betadine (C)

EXPERIMENTAL

Mouth rinse with betadine mouthwash,

Other: Betadine (C) Mouth rinse with the solution provided

Mouth wash (D)

EXPERIMENTAL

Mouth rinse with alcohol-based mouthwash

Other: Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution provided

Water (E)

PLACEBO COMPARATOR

Mouth rinse with water

Other: Water (E) Mouth rinse with the solution provided

Interventions

Water (E) Mouth rinse with the solution providedOTHER

Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.

Water (E)
Chlorhexidine gluconate (A) Mouth rinse with the solution providedOTHER

Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.

Chlorhexidine gluconate (A)
Hydrogen peroxide (B) Mouth rinse with the solution providedOTHER

Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.

Hydrogen peroxide (B)
Betadine (C) Mouth rinse with the solution providedOTHER

Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.

Betadine (C)
Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution providedOTHER

Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.

Mouth wash (D)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject of both sexes, aged 18 years or older
  • Patients who are confirmed positive for COVID-19.
  • Patients currently hospitalized at Augusta University Medical Center.
  • Subject voluntarily signing the informed consent document.

You may not qualify if:

  • Age younger than 18 years old.
  • Patients that are tested negative for COVID-19
  • Patient who are intubated or too sick to give consent for the study.
  • Not able to speak in English or illiterate or lacking the decision-making capacity to consent for study.
  • Known allergy to Listerine, Betadine or Chlorhexidine gluconate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Augusta University

Augusta, Georgia, 30901, United States

Location

Augusta University-Dental College of Georgia

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

WaterMouthwasheschlorhexidine gluconateHydrogen PeroxidePovidone-IodineEthanolListerineFumigant 93

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsBiomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and AgriculturePeroxidesReactive Oxygen SpeciesFree RadicalsOrganic ChemicalsIodophorsIodine CompoundsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesAlcohols

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 21, 2020

First Posted

January 22, 2021

Study Start

October 6, 2020

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)