Efficacy of Mouthwash in Reducing Salivary Carriage of COVID-19

NCT04603794 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2020H0346
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers know that the virus that causes COVID-19 has been found in the saliva (spit) of individuals who exhibit signs of the disease. Investigators would like to test the ability of three mouthwashes to reduce the levels of this virus in participants' mouths. Investigators will ask participants to use a liquid to swish around in the mouth for 30 seconds and spit it into a collection cup. Investigators will also collect spit from participants before and after participants use the mouthwash. Although participants will have no direct benefits from the study, investigators will gain a wealth of information that would benefit patients who are at risk for COVID-19.

Conditions

COVID-19

Keywords

Mouthwashes; COVID-19; Salivary Carriage; Povidone-Iodine; PCR (Polymerase Chain Reaction); Dental Aerosols

Outcome Measures

Primary Outcomes (2)

• real time reverse transcriptase quantitative PCR

  Saliva load was expressed in copies x 10 8 of COVID-19 RNA

  3 measurements of changes from times 0 minutes. vs:15 minutes, and vs: 45 minutes during a single session

• ct values

  cycle thresholds

  3 measurements of changes from times 0 minutes.vs:15 minutes, and vs:45 minutes during a single session

Study Arms (4)

1% Hydrogen Peroxide Mouth Rinse

ACTIVE COMPARATOR

30 second oral rinse with 1% Hydrogen Peroxide

Drug: 1% Hydrogen Peroxide

0.12% Chlorhexidine Gluconate Mouth Rinse

ACTIVE COMPARATOR

30 second oral rinse with 0.12% Chlorhexidine Gluconate

Drug: 0.12% Chlorhexidine Gluconate Mouth Rinse

0.5% Povidone Iodine Mouth Rinse

ACTIVE COMPARATOR

30 second oral rinse with 0.5% Povidone Iodine Mouth wash

Drug: 0.5% Povidone Iodine

0.9% Normal Saline Mouth Rinse

PLACEBO COMPARATOR

30 second oral rinse with 0.9% Normal Saline

Drug: 0.9% Normal Saline

Interventions

0.5% Povidone Iodine DRUG

Commercially Available Mouth Rinses and Over the Counter Standard Formulations

Also known as: Betadine Mouthwash

0.5% Povidone Iodine Mouth Rinse

0.12% Chlorhexidine Gluconate Mouth Rinse DRUG

Commercially Available Mouth Rinses

Also known as: Peridex

0.12% Chlorhexidine Gluconate Mouth Rinse

1% Hydrogen Peroxide DRUG

Commercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia)

Also known as: Hydrogen Peroxide

1% Hydrogen Peroxide Mouth Rinse

0.9% Normal Saline DRUG

Commercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia)

Also known as: Salt Water

0.9% Normal Saline Mouth Rinse

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults age 18-80 admitted to The Ohio State University Medical Center,
• diagnosis of COVID-19 confirmed by Polymerase Chain Reaction (PCR),
• salivary carriage of COVID-19 virus
• ability to perform mouthwash rinses and to expectorate.

You may not qualify if:

• allergy to any study mouth rinse,
• active uncontrolled thyroid disease,
• pregnancy
• patients undergoing radioactive iodine therapy.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (10)

• Serban D, Banu A, Serban C, Tuta-Sas I, Vlaicu B. Predictors of quantitative microbiological analysis of spatter and aerosolization during scaling. Rev Med Chir Soc Med Nat Iasi. 2013 Apr-Jun;117(2):503-8.

  PMID: 24340537 BACKGROUND

• Gupta G, Mitra D, Ashok KP, Gupta A, Soni S, Ahmed S, Arya A. Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study. J Periodontol. 2014 Apr;85(4):562-8. doi: 10.1902/jop.2013.120616. Epub 2013 Jul 15.

  PMID: 23855840 BACKGROUND

• Shetty SK, Sharath K, Shenoy S, Sreekumar C, Shetty RN, Biju T. Compare the effcacy of two commercially available mouthrinses in reducing viable bacterial count in dental aerosol produced during ultrasonic scaling when used as a preprocedural rinse. J Contemp Dent Pract. 2013 Sep 1;14(5):848-51. doi: 10.5005/jp-journals-10024-1414.

  PMID: 24685786 BACKGROUND

• Devker NR, Mohitey J, Vibhute A, Chouhan VS, Chavan P, Malagi S, Joseph R. A study to evaluate and compare the efficacy of preprocedural mouthrinsing and high volume evacuator attachment alone and in combination in reducing the amount of viable aerosols produced during ultrasonic scaling procedure. J Contemp Dent Pract. 2012 Sep 1;13(5):681-9. doi: 10.5005/jp-journals-10024-1209.

  PMID: 23250175 BACKGROUND

• Klyn SL, Cummings DE, Richardson BW, Davis RD. Reduction of bacteria-containing spray produced during ultrasonic scaling. Gen Dent. 2001 Nov-Dec;49(6):648-52.

  PMID: 12024755 BACKGROUND

• Wirthlin MR, Choi JH, Kye SB. Use of chlorine dioxide mouthrinse as the ultrasonic scaling lavage reduces the viable bacteria in the generated aerosols. J West Soc Periodontol Periodontal Abstr. 2006;54(2):35-44. No abstract available.

  PMID: 17214015 BACKGROUND

• Peng X, Xu X, Li Y, Cheng L, Zhou X, Ren B. Transmission routes of 2019-nCoV and controls in dental practice. Int J Oral Sci. 2020 Mar 3;12(1):9. doi: 10.1038/s41368-020-0075-9.

  PMID: 32127517 BACKGROUND

• Navazesh M. Methods for collecting saliva. Ann N Y Acad Sci. 1993 Sep 20;694:72-7. doi: 10.1111/j.1749-6632.1993.tb18343.x. No abstract available.

  PMID: 8215087 BACKGROUND

• To KK, Tsang OT, Yip CC, Chan KH, Wu TC, Chan JM, Leung WS, Chik TS, Choi CY, Kandamby DH, Lung DC, Tam AR, Poon RW, Fung AY, Hung IF, Cheng VC, Chan JF, Yuen KY. Consistent Detection of 2019 Novel Coronavirus in Saliva. Clin Infect Dis. 2020 Jul 28;71(15):841-843. doi: 10.1093/cid/ciaa149.

  PMID: 32047895 BACKGROUND

• Chaudhary P, Melkonyan A, Meethil A, Saraswat S, Hall DL, Cottle J, Wenzel M, Ayouty N, Bense S, Casanova F, Chaney M, Chase H, Hermel R, McClement M, Sesson C, Woolsey B, Kumar P. Estimating salivary carriage of severe acute respiratory syndrome coronavirus 2 in nonsymptomatic people and efficacy of mouthrinse in reducing viral load: A randomized controlled trial. J Am Dent Assoc. 2021 Nov;152(11):903-908. doi: 10.1016/j.adaj.2021.05.021. Epub 2021 Jun 11.

  PMID: 34561086 DERIVED

Related Links

• Povidone-iodine demonstrates rapid in-vitro Activity...
• Viral dynamics in asymptomatic patients with COVID-19

MeSH Terms

Conditions

COVID-19; Pathologic Complete Response

Interventions

Povidone-Iodine; chlorhexidine gluconate; Hydrogen Peroxide; Saline Solution; Fluoridation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Peroxides; Oxides; Anions; Ions; Electrolytes; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health

Study Officials

• David L Hall, DDS

  The Ohio State University College of Dentistry

  STUDY DIRECTOR

Central Study Contacts

David L Hall, DDS

CONTACT

614-292-2622; hall.611@osu.edu

Purnima Kumar, PhD,DDS

CONTACT

614-804-2112; kumar.83@osu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blinded. All mouthwash vials are masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Hospital Attending

Model Details: This randomized, cross-sectional, double blinded, negative controlled, four armed, prospective, interventional study compared Normal Saline, Hydrogen Peroxide, Chlorhexidine and Povidone-Iodine Mouth Rinses in 60 subjects being treated for Covid 19 at the The Ohio State University Medical Center. Real time reverse transcriptase quantitative PCR measured viral loads.

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: October 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)