Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-25 @ 4:06 PM
Study NCT ID:
NCT04721457
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2021-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Pre-procedural Mouth Rinses on COVID-19 Saliva Viral Load
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}, {'id': 'D011206', 'term': 'Povidone-Iodine'}, {'id': 'D009067', 'term': 'Mouthwashes'}, {'id': 'D006861', 'term': 'Hydrogen Peroxide'}, {'id': 'D002594', 'term': 'Cetylpyridinium'}, {'id': 'C546060', 'term': 'hydrated silica gel-based toothpaste'}, {'id': 'D012973', 'term': 'Sodium Hypochlorite'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D003358', 'term': 'Cosmetics'}, {'id': 'D010545', 'term': 'Peroxides'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D011726', 'term': 'Pyridinium Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006997', 'term': 'Hypochlorous Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Allocated mouth rinses will be concealed in opaque sealed envelopes. Each envelope contains a 15 ml sterile amber test tube filled with the assigned mouth rinse, a 120 ml sterile empty specimen container for expectoration of the mouth rinse, and four identical empty 50 ml sterile test tubes for collecting saliva samples, each labeled with the allocated number and time point (T0, T1, T2, or T3), and a biohazard bag.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This randomizeda, single-center, randomized, double-blind, six-parallel-group, placebo-controlled trial compares the efficacy of four commercially available mouth rinses povidone-iodine (PVP-I), hydrogen peroxide (H2O2), cetylpyridinium chloride (CPC), sodium hypochlorite (NaOCl) on the salivary SARS-CoV-2 viral load at four-time points (baseline and 5-, 30-, and 60-min post rinsing) relative to two control groups (distilled water and no-rinse) in a cohort of positive COVID-19 patients.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the salivary viral load within each mouth rinse groups and controls', 'timeFrame': 'Baseline (T0) vs 5 minutes (T1), baseline (T0) vs 30 minutes (T2), and baseline (T0) vs 60 minutes T3)', 'description': 'change in the salivary viral load overtime within each group will be measured by quantitative reverse transcription PCR (RT-qPCR) and expressed as copies/ml'}, {'measure': 'Compare salivary viral load between mouth rinse groups and controls at baseline', 'timeFrame': 'Compare Baseline (T0)', 'description': 'Difference in Salivary viral load baseline value between the groups'}, {'measure': 'Compare salivary viral load between mouth rinse groups and controls at 5 minutes post rinsing', 'timeFrame': '5 minutes post rinsing (T1)', 'description': 'Difference in Salivary viral load baseline value between the groups'}, {'measure': 'Compare salivary viral load between mouth rinse groups and controls at 30 minutes post rinsing', 'timeFrame': '30 minutes post rinsing (T2)', 'description': 'Difference in Salivary viral load baseline value between the groups'}, {'measure': 'Compare salivary viral load between mouth rinse groups and controls at 60 minutes post rinsing', 'timeFrame': '60 minutes post rinsing (T3)', 'description': 'Difference in Salivary viral load baseline value between the groups'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV-2', 'COVID-19', 'Mouthwashes', 'Viral Load', 'Polymerase Chain Reaction', 'Coronavirus', 'Covid19', 'Saliva']}, 'referencesModule': {'references': [{'pmid': '32047895', 'type': 'RESULT', 'citation': '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': '32425001', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32859459', 'type': 'RESULT', 'citation': 'Vergara-Buenaventura A, Castro-Ruiz C. Use of mouthwashes against COVID-19 in dentistry. Br J Oral Maxillofac Surg. 2020 Oct;58(8):924-927. doi: 10.1016/j.bjoms.2020.08.016. Epub 2020 Aug 15.'}, {'pmid': '33215159', 'type': 'RESULT', 'citation': "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."}, {'pmid': '32326426', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32159775', 'type': 'RESULT', 'citation': 'Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, Tan W. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020 May 12;323(18):1843-1844. doi: 10.1001/jama.2020.3786.'}, {'pmid': '17099299', 'type': 'RESULT', 'citation': 'Bruch MK. Toxicity and safety of topical sodium hypochlorite. Contrib Nephrol. 2007;154:24-38. doi: 10.1159/000096812.'}, {'pmid': '23017003', 'type': 'RESULT', 'citation': 'De Nardo R, Chiappe V, Gomez M, Romanelli H, Slots J. Effects of 0.05% sodium hypochlorite oral rinse on supragingival biofilm and gingival inflammation. Int Dent J. 2012 Aug;62(4):208-12. doi: 10.1111/j.1875-595X.2011.00111.x. Epub 2012 May 11.'}, {'pmid': '30639191', 'type': 'RESULT', 'citation': 'Seo HW, Seo JP, Cho Y, Ko E, Kim YJ, Jung G. Cetylpyridinium chloride interaction with the hepatitis B virus core protein inhibits capsid assembly. Virus Res. 2019 Apr 2;263:102-111. doi: 10.1016/j.virusres.2019.01.004. Epub 2019 Jan 9.'}, {'pmid': '20354090', 'type': 'RESULT', 'citation': 'Feres M, Figueiredo LC, Faveri M, Stewart B, de Vizio W. The effectiveness of a preprocedural mouthrinse containing cetylpyridinium chloride in reducing bacteria in the dental office. J Am Dent Assoc. 2010 Apr;141(4):415-22. doi: 10.14219/jada.archive.2010.0193.'}, {'pmid': '31761015', 'type': 'RESULT', 'citation': 'Marui VC, Souto MLS, Rovai ES, Romito GA, Chambrone L, Pannuti CM. Efficacy of preprocedural mouthrinses in the reduction of microorganisms in aerosol: A systematic review. J Am Dent Assoc. 2019 Dec;150(12):1015-1026.e1. doi: 10.1016/j.adaj.2019.06.024.'}, {'pmid': '11505791', 'type': 'RESULT', 'citation': 'Pitten FA, Kramer A. Efficacy of cetylpyridinium chloride used as oropharyngeal antiseptic. Arzneimittelforschung. 2001;51(7):588-95. doi: 10.1055/s-0031-1300084.'}, {'pmid': '23433693', 'type': 'RESULT', 'citation': 'Osso D, Kanani N. Antiseptic mouth rinses: an update on comparative effectiveness, risks and recommendations. J Dent Hyg. 2013 Feb;87(1):10-8. Epub 2013 Feb 5.'}, {'pmid': '32505069', 'type': 'RESULT', 'citation': 'Caruso AA, Del Prete A, Lazzarino AI. Hydrogen peroxide and viral infections: A literature review with research hypothesis definition in relation to the current covid-19 pandemic. Med Hypotheses. 2020 Nov;144:109910. doi: 10.1016/j.mehy.2020.109910. Epub 2020 Jun 1.'}, {'pmid': '11225528', 'type': 'RESULT', 'citation': 'Walsh LJ. Safety issues relating to the use of hydrogen peroxide in dentistry. Aust Dent J. 2000 Dec;45(4):257-69; quiz 289. doi: 10.1111/j.1834-7819.2000.tb00261.x.'}, {'pmid': '29633177', 'type': 'RESULT', 'citation': 'Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9.'}, {'pmid': '16490989', 'type': 'RESULT', 'citation': 'Kariwa H, Fujii N, Takashima I. Inactivation of SARS coronavirus by means of povidone-iodine, physical conditions and chemical reagents. Dermatology. 2006;212 Suppl 1(Suppl 1):119-23. doi: 10.1159/000089211.'}]}, 'descriptionModule': {'briefSummary': "Preoperative antiseptic mouth rinses have been widely used as a standard protocol before routine dental treatment reduces oral microorganism counts. During dental procedures, aerosolized microorganisms contaminate the dental environment and nearby surfaces and remain suspended for 4 hours. Thus, the reduction in the number of aerosolized microorganisms by pre-procedural rinsing may reduce cross-contamination between dentists, office personnel, and patients. Recent reviews have advocated the use of preoperative rinsing to control and reduce the risk of SARS-CoV-2 transmission. However, no clinical studies have been done yet to support the effectiveness of any pre-procedural oral rinses against SARS-CoV-2. The proposed study will mitigate the spread of COVID-19 disease in dental healthcare facilities and ensure the patients' good health and healthcare workers. The purpose of this clinical trial is to compare the efficacy of four commercially available mouth rinses povidone-iodine (PVP-I), hydrogen peroxide (H2O2), cetylpyridinium chloride (CPC), sodium hypochlorite (NaOCl) on the salivary SARS-CoV-2 viral load at four-time points (baseline and 5-, 30-, and 60-min post rinsing) relative to two control groups (distilled water and no-rinse) in a cohort of positive COVID-19 patients.", 'detailedDescription': 'Saliva specimens will be collected from COVID-19-positive patients presenting to TETAMMAN clinics from January to March 2021. The total number of participants in this study will be 90 participants, with 15 per group (6 groups), and 4 saliva specimens from each patient in each group. A total of four mouth rinses and two control groups (distilled water and no-rinse). The studied mouth rinses were: 1% povidone-iodine (PVP-I) (Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA), 1.5% hydrogen peroxide (H2O2) (Peroxyl; Colgate-Palmolive, Guildford, UK), 0.075% cetylpyridinium chloride (CPC) (Colgate Total; Colgate-Palmolive, Guildford, UK), 80 ppm sodium hypochlorite (NaOCl) (Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK). Confirmed positive cases of COVID-19 will be recruited randomly at each TETAMMAN clinic based on inclusion and exclusion criteria to satisfy the total of 90 patients. Each participant will be introduced briefly to the study aims and then asked to sign a consent form. Demographic data and medical history will then be collected for each participant. The participants will be blinded to all mouth rinses, which will be labeled with identification codes, and presented in similar packages. Unstimulated saliva will be collected using the passive drool technique. Four saliva samples for each patient will be collected. The first saliva sample will be considered as a baseline sample that represents the baseline viral load. Then patients will be instructed to gargle the assigned mouth rinse gently, for 15 seconds. After that, the participants will spit the mouthwashes into a disposable plastic cup. After that, different salivary samples will be collected at 5 minutes, 30 minutes, and then 60 minutes. Thus, a total of four saliva samples will be gathered from each patient. The viral load will be measured by quantitative reverse transcription PCR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults age 18 years or older presented to TETAMMAN clinics, Jeddah, Saudi Arabia.\n2. COVID-19-positive patients confirmed by RT-PCR and within two days of oral or nasopharyngeal swabs\n3. Asymptomatic or within seven days of the onset of symptoms.\n4. Has the ability to rinse and expectorate.\n\nExclusion Criteria:\n\n1. Participants who established antiviral, corticosteroid, antimicrobial, or immunosuppressive medications.\n2. Known allergy to one of the constituents of the mouth rinse\n3. Thyroid disease or on current radioactive iodine treatment\n4. Pregnant or breastfeeding women\n5. Lithium therapy\n6. History of radiotherapy or chemotherapy\n7. Use of mouthwash before presented to TETAMMAN clinics'}, 'identificationModule': {'nctId': 'NCT04721457', 'briefTitle': 'The Efficacy of Pre-procedural Mouth Rinses on COVID-19 Saliva Viral Load', 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'officialTitle': 'Mouth Rinses Efficacy on Salivary SARS-CoV-2 Viral Load: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'H-02-J-002; 1384'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Distilled Water', 'description': 'Vigorously rinse with 15 ml of the distilled water for 30 s (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA)', 'interventionNames': ['Drug: Distilled Water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Povidone Iodine (PVP-I)', 'description': 'Vigorously rinse with 15 ml of the 1% povidone-iodine (PVP-I) (Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA) for 30 s', 'interventionNames': ['Drug: 1% Povidone Iodine (PVP-I)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrogen Peroxide (H2O2)', 'description': 'Vigorously rinse with 15 ml of the 1.5% hydrogen peroxide (H2O2) (Peroxyl; Colgate-Palmolive, Guildford, UK) for 30 s', 'interventionNames': ['Drug: 1.5% Hydrogen Peroxide (H2O2)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cetylpyridinium Chloride (CPC)', 'description': 'Vigorously rinse with 15 ml of the 0.075% cetylpyridinium chloride (CPC) (Colgate Total; Colgate-Palmolive, Guildford, UK) for 30 s', 'interventionNames': ['Drug: 0.075% Cetylpyridinium Chloride (CPC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium Hypochlorite', 'description': 'Vigorously rinse with 15 ml of the 80 ppm sodium hypochlorite (NaOCl) (Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK) for 30 s', 'interventionNames': ['Drug: 0.1% Sodium Hypochlorite']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No rinse group', 'description': 'There is no mouth rinse in this group. Patients will collect the saliva at all 4-time points without gargling with the mouth rinse.', 'interventionNames': ['Other: No rinse group']}], 'interventions': [{'name': 'Distilled Water', 'type': 'DRUG', 'otherNames': ['water (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA)'], 'description': 'Control group', 'armGroupLabels': ['Distilled Water']}, {'name': '1% Povidone Iodine (PVP-I)', 'type': 'DRUG', 'otherNames': ['Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA'], 'description': 'Over-the-counter antiseptic mouth rinse', 'armGroupLabels': ['Povidone Iodine (PVP-I)']}, {'name': '1.5% Hydrogen Peroxide (H2O2)', 'type': 'DRUG', 'otherNames': ['Peroxyl; Colgate-Palmolive, Guildford, UK'], 'description': 'Over-the-counter antiseptic mouth rinse', 'armGroupLabels': ['Hydrogen Peroxide (H2O2)']}, {'name': '0.075% Cetylpyridinium Chloride (CPC)', 'type': 'DRUG', 'otherNames': ['Colgate Total; Colgate-Palmolive, Guildford, UK'], 'description': 'Over-the-counter antiseptic mouth rinse', 'armGroupLabels': ['Cetylpyridinium Chloride (CPC)']}, {'name': '0.1% Sodium Hypochlorite', 'type': 'DRUG', 'otherNames': ['Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK'], 'description': 'Over-the-counter antiseptic mouth rinse', 'armGroupLabels': ['Sodium Hypochlorite']}, {'name': 'No rinse group', 'type': 'OTHER', 'description': 'second control group', 'armGroupLabels': ['No rinse group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Alhamra TETAMMAN clinic (PHC)', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'MANAR M ALZAHRANI, MSD, FRCD(C)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Abdulaziz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'MANAR ALZAHRANI', 'investigatorAffiliation': 'King Abdulaziz University'}}}}