Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19
NCT ID: NCT04748783
Last Updated: 2022-02-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2021-03-26
2021-04-07
Brief Summary
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Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one hour (15, 30, 45 and 60 min). The saliva will be used for RT-PCR detection of Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) and viral infectivity assays, along with quantitative cytokine and chemokine concentration (pg/mL, Luminex).
Subjects will complete a short survey on the taste and experience of using the mouthwash.
Peripheral blood will be collected at the end of salivary collection. Subjects, except controls, will be provided materials and oral hygiene instruction related to daily use of oral hygiene products. In the seven-day period between study visit one and study visit two, subjects will be directed to brush with Colgate toothpaste (at least twice per day) and rinse with the Colgate mouthrinse (according to on-label procedures). Controls are asked to carry out their typical oral hygiene regimen with the products they typically use.
All subjects keep a daily diary of oral hygiene performance, product usage, COVID-19 symptoms and exposures. Subjects complete study visit two one week after the baseline visit during which additional salivary (1 time point, 2 mL of saliva over 5 min, no rinse) will occur and blood samples collected. each subject will undergo a periodontal exam.
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Detailed Description
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Subjects will be randomized to a mouthrinse and will be asked to give a saliva sample immediately before and after a 30-60 second mouthwash.
Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one hour (15, 30, 45 and 60 min). The saliva samples will be stored and used for RT-PCR detection of SARS-CoV-2 virus and viral infectivity assays, along with quantitative cytokine and chemokine concentration (pg/mL, Luminex).
Subjects will also complete a short survey on the taste and experience of using the mouthwash.
Peripheral blood will be collected at the end of salivary collection. Subjects, except controls, will be provided materials and oral hygiene instruction related to daily use of oral hygiene products provided by the study. In the seven-day period between study visits, subjects will be directed to brush with Colgate toothpaste (at least twice per day) and rinse with the Colgate mouthrinse (according to on-label procedures). Controls are not given Colgate products and will be asked to carry out their typical oral hygiene regimen with the products they typically use. All subjects will be asked to keep a daily diary of oral hygiene performance, product usage, COVID-19 symptoms and exposures.
Subjects will be scheduled to return to the research clinic at one week after the baseline assessment, during which additional salivary (1 time point, 2 mL of saliva over 5 min, no rinse will occur) and blood samples will be collected. At the conclusion of sample collection, the subject will undergo a periodontal exam. Study participation concludes following the periodontal exam at the end of the second on site study visit. Patients with any periodontitis or gingivitis diagnosis will be informed of their diagnosis and will be referred to an oral healthcare provider for further treatment. This study involves two 90-minute visits.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sterile water
Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water
Water
Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water.
Peroxyl
Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse
Peroxyl
Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse
Periogard
Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.
Periogard
Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.
Peroxyl & Periogard
Subject participants will complete an on-label sequential rinse starting with Peroxyl (1st) 10ml for 60 seconds and then Periogard (2nd) 15ml for 30 seconds.
Peroxyl
Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse
Periogard
Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.
Colgate Total Zero
Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20ml for 30 seconds
Colgate Total Zero
Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20ml for 30 seconds
Interventions
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Water
Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water.
Peroxyl
Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse
Periogard
Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.
Colgate Total Zero
Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20ml for 30 seconds
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individuals (all sex, all gender) at least 18 years of age and at most 65 years of age and in good oral health without any known allergies to commercial dental products or cosmetics. American Society of Anaesthesiologists (ASA) class I or II prior to SARS-CoV-2 infection.
* Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered.
* Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment.
* Females of childbearing potential will have a negative urine pregnancy test (on site) or be physically incapable of pregnancy (implants or injections, Intrauterine device, Bilateral tubal ligation, Hysterectomy, Ovariectomy, Women post-menopausal)
Exclusion Criteria
* Patients who have been eating or drinking within an hour of the study
* Patients under 18 years of age and older than 65 years of age
* Subjects presenting with and/or self-reporting any of the following will not be included in the study:
* history of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. (self-reported)
* Self-reported allergy to hydrogen peroxide, peroxyl, chlorhexidine gluconate, periogard, peridex, colgate total zero, colgate total, cetylpyridinium chloride, essential oils (Eucalyptol, Menthol, Methyl salicylate, Thymol), and other components in the mouth rinses (methyl salicylate, ethanol, saccharin sodium, glycerin, propylene glycol, sorbitol, Federal Food, Drug, and Cosmetic (FD\&C) blue additive no. 1, Poloxamer 407, Benzoic acid, Zinc chloride, Sodium benzoate, Sucralose, Polyethylene Glycol (PEG-40) sorbitan diisostearate, potassium sorbate, citric acid).
* History of serious medical conditions that, at the discretion of the Investigator, will disqualify the subject. (Self-reported)
* A history of severe dry mouth (xerostomia), severe drug-induced xerostomia (antidepressants, anticonvulsants, antihypertensives), or Sjogren's syndrome
* A history of recent (within the last 30 days) or current recent oral herpes flare up, candida (thrush) infection, apthous ulcer flare up, current/active severe periodontal disease, or other recent oral viral infection or flare up within the past 30 days (self-reported)
* Current history of alcohol or drug abuse (self-reported).
* History of drinking water or eating food within an hour of the study visit.
* History of drinking alcohol within 12 hours of the study visit.
* History of using a commercial mouthrinse within 24 hours of the study visit.
* Participation in any study involving oral care products, concurrently or within the previous 30 days. (self-reported)
* Positive pregnancy test reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results. Additionally, women are advised to check with their physician before using Chlorhexidine Gluconate during pregnancy and lactation, which cannot occur in a blinded, randomized trial.)
* Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial.
* Patient with developmental/cognitive disability that cannot self-consent, comprehend and follow the requirements of the study based on research site personnel's assessment.
* Patients with sizable mucosal tears, abrasions, growths or burns in the mouth
* Patients with kidney dysfunction
18 Years
65 Years
ALL
Yes
Sponsors
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Colgate Palmolive
INDUSTRY
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Laura a Jacox, DMD, PhD, MS
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Adams School of Dentistry
Chapel Hill, North Carolina, United States
Countries
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References
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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).
Sorveglianza Integrata COVID-19 in Italia. Instituto Superiore di Sanitahttps://portale.fnomceo.it/wp-content/uploads/2020/04/Infografica_9aprile-ITA.pdf (2020).
O'Donnell VB, Thomas D, Stanton R, Maillard JY, Murphy RC, Jones SA, Humphreys I, Wakelam MJO, Fegan C, Wise MP, Bosch A, Sattar SA. Potential Role of Oral Rinses Targeting the Viral Lipid Envelope in SARS-CoV-2 Infection. Function (Oxf). 2020;1(1):zqaa002. doi: 10.1093/function/zqaa002. Epub 2020 Jun 5.
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.
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.
Ather A, Patel B, Ruparel NB, Diogenes A, Hargreaves KM. Reply to "Coronavirus Disease 19 (COVID-19): Implications for Clinical Dental Care". J Endod. 2020 Sep;46(9):1342. doi: 10.1016/j.joen.2020.08.005. Epub 2020 Aug 15. 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.
Cleveland JL, Gray SK, Harte JA, Robison VA, Moorman AC, Gooch BF. Transmission of blood-borne pathogens in US dental health care settings: 2016 update. J Am Dent Assoc. 2016 Sep;147(9):729-38. doi: 10.1016/j.adaj.2016.03.020. Epub 2016 May 24.
Pfefferle, S. et al.Low and high infection dose transmission of SARS-CoV-2 in the first COVID-19 clusters in Northern Germany. medRxiv (2020) doi:10.1101/2020.06.11.20127332
Ge ZY, Yang LM, Xia JJ, Fu XH, Zhang YZ. Possible aerosol transmission of COVID-19 and special precautions in dentistry. J Zhejiang Univ Sci B. 2020 May;21(5):361-368. doi: 10.1631/jzus.B2010010. Epub 2020 Mar 16.
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.
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.
Hasheminia D, Moaddabi A, Moradi S, Soltani P, Moannaei M, Issazadeh M. The efficacy of 1% Betadine mouthwash on the incidence of dry socket after mandibular third molar surgery. J Clin Exp Dent. 2018 May 1;10(5):e445-e449. doi: 10.4317/jced.54444. eCollection 2018 May.
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.
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
Statkute, E., Rubina, A., O'Donnell, V., Thomas, D., & Stanton, R. The Virucidal Efficacy of Oral Rinse Components Against SARS-CoV-2 In Vitro. BiorXiv. doi.org/10.1101/2020.11.13.381079
COVID-19 Frequently Asked Questions. American Dental Association: Center for Professional Success (2020).
Meiller TF, Silva A, Ferreira SM, Jabra-Rizk MA, Kelley JI, DePaola LG. Efficacy of Listerine Antiseptic in reducing viral contamination of saliva. J Clin Periodontol. 2005 Apr;32(4):341-6. doi: 10.1111/j.1600-051X.2005.00673.x.
Chapple ILC, Mealey BL, Van Dyke TE, Bartold PM, Dommisch H, Eickholz P, Geisinger ML, Genco RJ, Glogauer M, Goldstein M, Griffin TJ, Holmstrup P, Johnson GK, Kapila Y, Lang NP, Meyle J, Murakami S, Plemons J, Romito GA, Shapira L, Tatakis DN, Teughels W, Trombelli L, Walter C, Wimmer G, Xenoudi P, Yoshie H. Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S74-S84. doi: 10.1002/JPER.17-0719.
Eke PI, Page RC, Wei L, Thornton-Evans G, Genco RJ. Update of the case definitions for population-based surveillance of periodontitis. J Periodontol. 2012 Dec;83(12):1449-54. doi: 10.1902/jop.2012.110664. Epub 2012 Mar 16.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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COL Study
Identifier Type: OTHER
Identifier Source: secondary_id
20-3046
Identifier Type: -
Identifier Source: org_study_id
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