Study Summary
This trial is testing whether or not therapeutic, antiseptic mouth rinses can inactivate the severe acute respiratory syndrome coronavirus (SARS-CoV-2) in saliva of COVID-19 positive patients.
Eligible Conditions
- Coronavirus
- COVID-19
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: Baseline, 30 minutes
Baseline, 15 minutes
Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 15 Minutes
Baseline, 30 minutes
Change in Quantitative Polymerase Chain Reaction (qPCR) from Baseline to 30 Minutes
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
27% Ethanol plus essential oils
1 of 3
0.075% Cetylpyridinium Chloride
1 of 3
Sterile Water
1 of 3
Active Control
Non-Treatment Group
150 Total Participants · 3 Treatment Groups
Primary Treatment: 27% Ethanol plus essential oils · Has Placebo Group · N/A
27% Ethanol plus essential oils
Other
ActiveComparator Group · 1 Intervention: 27% Ethanol plus essential oils · Intervention Types: Other0.075% Cetylpyridinium Chloride
Other
ActiveComparator Group · 1 Intervention: 0.075% Cetylpyridinium Chloride · Intervention Types: OtherSterile Water
Other
PlaceboComparator Group · 1 Intervention: Placebo Comparator: Sterile Water · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 30 minutes
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,384 Previous Clinical Trials
3,938,130 Total Patients Enrolled
Laura A Jacox, DMD, PhDPrincipal InvestigatorUniversity of North Carolina Adams School of Dentistry
Eligibility Criteria
Age 18 - 65 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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- Pfefferle, S. et al.Low and high infection dose transmission of SARSCoV-2 in the first COVID-19 clusters in Northern Germany. medRxiv(2020) doi:10.1101/2020.06.11.20127332.
- Sorveglianza Integrata COVID-19 in Italia. Instituto Superiore di Sanitahttps:// portale.fnomceo.it/wp-content/uploads/2020/04/Infografica_9aprile-ITA.pdf (2020).
- State Officials Announce Latest COVID-19 Facts Including New Data on Racial Demographics and Expanded Health Care Worker Data. California Department of Public Health (2020).
- Sethuraman, Nandini, Sundararaj Stanleyraj Jeremiah, and Akihide Ryo. 2020. “Interpreting Diagnostic Tests for Sars-cov-2”. Jama. American Medical Association (AMA). doi:10.1001/jama.2020.8259.
- Izzetti, R., M. Nisi, M. Gabriele, and F. Graziani. 2020. “COVID-19 Transmission in Dental Practice: Brief Review of Preventive Measures in Italy”. Journal of Dental Research. SAGE Publications. doi:10.1177/0022034520920580.
- O’Donnell, Valerie B, David Thomas, Richard Stanton, Jean-Yves Maillard, Robert C Murphy, Simon A Jones, Ian Humphreys, et al.. 2020. “Potential Role of Oral Rinses Targeting the Viral Lipid Envelope in Sars-cov-2 Infection”. Function. Oxford University Press (OUP). doi:10.1093/function/zqaa002.
- Carrouel, Florence, Maria Pia Conte, Julian Fisher, Lucio Souza Gonçalves, Claude Dussart, Juan Carlos Llodra, and Denis Bourgeois. 2020. “COVID-19: A Recommendation to Examine the Effect of Mouthrinses with Β-cyclodextrin Combined with Citrox in Preventing Infection and Progression”. Journal of Clinical Medicine. MDPI AG. doi:10.3390/jcm9041126.
- Baghizadeh Fini, Maryam. 2020. “What Dentists Need to Know About COVID-19”. Oral Oncology. Elsevier BV. doi:10.1016/j.oraloncology.2020.104741.
- Cleveland, Jennifer L., Shellie Kolavic Gray, Jennifer A. Harte, Valerie A. Robison, Anne C. Moorman, and Barbara F. Gooch. 2016. “Transmission of Blood-borne Pathogens in US Dental Health Care Settings”. The Journal of the American Dental Association. Elsevier BV. doi:10.1016/j.adaj.2016.03.020.
- Dennison, David K., Gerald M. Meredith, Edward J. Shillitoe, and Raul G. Caffesse. 1995. “The Antiviral Spectrum of Listerine Antiseptic”. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology. Elsevier BV. doi:10.1016/s1079-2104(05)80124-6.
- Hasheminia, D, A Moaddabi, S Moradi, P Soltani, M Moannaei, and M Issazadeh. 2018. “The Efficacy of 1% Betadine Mouthwash on the Incidence of Dry Socket After Mandibular Third Molar Surgery”. Journal of Clinical and Experimental Dentistry. Medicina Oral, S.L.. doi:10.4317/jced.54444.
- Ge, Zi-yu, Lu-ming Yang, Jia-jia Xia, Xiao-hui Fu, and Yan-zhen Zhang. 2020. “Possible Aerosol Transmission of COVID-19 and Special Precautions in Dentistry”. Journal of Zhejiang University-science B. Zhejiang University Press. doi:10.1631/jzus.b2010010.
- HARREL, STEPHEN K., and JOHN MOLINARI. 2004. “Aerosols and Splatter in Dentistry”. The Journal of the American Dental Association. Elsevier BV. doi:10.14219/jada.archive.2004.0207.
- Ather, Amber, Biraj Patel, Nikita B. Ruparel, Anibal Diogenes, and Kenneth M. Hargreaves. 2020. “Coronavirus Disease 19 (COVID-19): Implications for Clinical Dental Care”. Journal of Endodontics. Elsevier BV. doi:10.1016/j.joen.2020.03.008.
- COVID-19 Frequently Asked Questions. American Dental Association: Center for Professional Success (2020)
- Kirk-Bayley, J., Challacombe, S., Sunkaraneni, V. & Combes, J. The Use of Povidone Iodine Nasal Spray and Mouthwash During the Current COVID-19 Pandemic May Protect Healthcare Workers and Reduce Cross Infection. SSRN Electron. J.(2020) doi:10.2139/ssrn.3563092.
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- Carrouel F, Conte MP, Fisher J, Goncalves LS, Dussart C, Llodra JC, Bourgeois D. COVID-19: A Recommendation to Examine the Effect of Mouthrinses with beta-Cyclodextrin Combined with Citrox in Preventing Infection and Progression. J Clin Med. 2020 Apr 15;9(4):1126. doi: 10.3390/jcm9041126.
- Harrel SK, Molinari J. Aerosols and splatter in dentistry: a brief review of the literature and infection control implications. J Am Dent Assoc. 2004 Apr;135(4):429-37. doi: 10.14219/jada.archive.2004.0207.
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- Sethuraman N, Jeremiah SS, Ryo A. Interpreting Diagnostic Tests for SARS-CoV-2. JAMA. 2020 Jun 9;323(22):2249-2251. doi: 10.1001/jama.2020.8259. No abstract available.
- Baghizadeh Fini M. What dentists need to know about COVID-19. Oral Oncol. 2020 Jun;105:104741. doi: 10.1016/j.oraloncology.2020.104741. Epub 2020 Apr 28.
- Izzetti R, Nisi M, Gabriele M, Graziani F. COVID-19 Transmission in Dental Practice: Brief Review of Preventive Measures in Italy. J Dent Res. 2020 Aug;99(9):1030-1038. doi: 10.1177/0022034520920580. Epub 2020 Apr 17.
- Dennison DK, Meredith GM, Shillitoe EJ, Caffesse RG. The antiviral spectrum of Listerine antiseptic. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1995 Apr;79(4):442-8. doi: 10.1016/s1079-2104(05)80124-6.
- Challacombe SJ, Kirk-Bayley J, Sunkaraneni VS, Combes J. Povidone iodine. Br Dent J. 2020 May;228(9):656-657. doi: 10.1038/s41415-020-1589-4. No abstract available.
- 2022. "Efficacy of Oral Rinses for Inactivation of COVID-19 (MOR2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05178173.
Frequently Asked Questions
May I be admitted into this experiment?
"This coronavirus study requires 150 participants aged between 18 and 65 with an active covid-19 infection. The candidates must be capable of understanding the protocol and fulfilling its demands, including being present on the days specified by researchers. In addition to this, they should not have any pre-existing allergies or oral health issues, as well as belong to American Society of Anesthesiologists (ASA) class I or II prior to contracting Covid-19." - Anonymous Online Contributor
Unverified Answer
Is enrollment still possible for this research endeavor?
"Affirmative. The clinicaltrials.gov records verify that this research is actively searching for participants, which was initially posted on the 20th of January 2022 and updated lastly on 7th February 2021. This investigation necessitates 150 individuals from 1 site to be recruited." - Anonymous Online Contributor
Unverified Answer
What is the aggregate size of those participating in this experiment?
"Affirmative. According to information located on clinicaltrials.gov, this investigation is actively searching for potential participants. It was initially posted on January 20th 2022 and underwent a recent update on February 7th 2022; it requires 150 enrollees from one medical centre" - Anonymous Online Contributor
Unverified Answer
Is the age criteria for this scientific research confined to those over seventy years old?
"This trial only admits participants aged between 18 and 65; however, there are alternative trials available for people outside that age bracket--336 of them are tailored to the under-18 group whereas 1460 cater to those above the age of 65." - Anonymous Online Contributor
Unverified Answer