The Efficacy of Pre-procedural Mouth Rinses on COVID-19 Saliva Viral Load

COVID-19 Clinical Trial

Official title:

Mouth Rinses Efficacy on Salivary SARS-CoV-2 Viral Load: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721457
• Other study ID #: H-02-J-002; 1384
• Status: Completed
• Phase: Phase 4
• Start date: January 3, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: July 2022
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 10, 2021
• Est. primary completion date: March 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults age 18 years or older presented to TETAMMAN clinics, Jeddah, Saudi Arabia.

2. COVID-19-positive patients confirmed by RT-PCR and within two days of oral or nasopharyngeal swabs

3. Asymptomatic or within seven days of the onset of symptoms.

4. Has the ability to rinse and expectorate.

Exclusion Criteria:

1. Participants who established antiviral, corticosteroid, antimicrobial, or immunosuppressive medications.

2. Known allergy to one of the constituents of the mouth rinse

3. Thyroid disease or on current radioactive iodine treatment

4. Pregnant or breastfeeding women

5. Lithium therapy

6. History of radiotherapy or chemotherapy

7. Use of mouthwash before presented to TETAMMAN clinics

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• Covid19
• Mouthwashes
• Polymerase Chain Reaction
• Saliva
• SARS-CoV-2
• Viral Load

Intervention

Drug:
• Distilled Water
Control group
• 1% Povidone Iodine (PVP-I)
Over-the-counter antiseptic mouth rinse
• 1.5% Hydrogen Peroxide (H2O2)
Over-the-counter antiseptic mouth rinse
• 0.075% Cetylpyridinium Chloride (CPC)
Over-the-counter antiseptic mouth rinse
• 0.1% Sodium Hypochlorite
Over-the-counter antiseptic mouth rinse

Other:
• No rinse group
second control group

Locations

Country	Name	City	State
Saudi Arabia	Alhamra TETAMMAN clinic (PHC)	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (17)

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Carrouel F, Conte MP, Fisher J, Gonçalves LS, Dussart C, Llodra JC, Bourgeois D. COVID-19: A Recommendation to Examine the Effect of Mouthrinses with ß-Cyclodextrin Combined with Citrox in Preventing Infection and Progression. J Clin Med. 2020 Apr 15;9(4) — View 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 — View Citation

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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 2 — View 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. — View 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. Review. — View Citation

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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. — View 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):zqaa00 — View 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. Review. — View Citation

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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. — View 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 — View 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. Review. — View Citation

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the salivary viral load within each mouth rinse groups and controls	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	Baseline (T0) vs 5 minutes (T1), baseline (T0) vs 30 minutes (T2), and baseline (T0) vs 60 minutes T3)
Primary	Compare salivary viral load between mouth rinse groups and controls at baseline	Difference in Salivary viral load baseline value between the groups	Compare Baseline (T0)
Primary	Compare salivary viral load between mouth rinse groups and controls at 5 minutes post rinsing	Difference in Salivary viral load baseline value between the groups	5 minutes post rinsing (T1)
Primary	Compare salivary viral load between mouth rinse groups and controls at 30 minutes post rinsing	Difference in Salivary viral load baseline value between the groups	30 minutes post rinsing (T2)
Primary	Compare salivary viral load between mouth rinse groups and controls at 60 minutes post rinsing	Difference in Salivary viral load baseline value between the groups	60 minutes post rinsing (T3)