MedDataX Logo

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

NCT ID: NCT04721457

Last Updated: 2022-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-03

Study Completion Date

2021-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Mouthwash in Reducing Salivary Carriage of COVID-19

NCT04603794

COVID-19
UNKNOWN PHASE4

Mouth Rinses for Inactivation of COVID-19

NCT04584684

Covid19 Coronavirus Infection SARS-CoV-2 Infection
TERMINATED PHASE2

The Role of Chlorhexidine in Minimizing the Viral Load Among COVID-19 Patients

NCT04941131

COVID-19
COMPLETED PHASE4

Efficacy of Mouthwashes in Reducing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load in the Saliva

NCT04723446

Covid19 Coronavirus
COMPLETED NA

[COVID-19] Reduction of Sars-CoV-2 Oral Viral Load With Prophylactic Mouth Rinse

NCT04719208

Covid19
UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Distilled Water

Vigorously rinse with 15 ml of the distilled water for 30 s (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA)

Group Type PLACEBO_COMPARATOR

Distilled Water

Intervention Type DRUG

Control group

Povidone Iodine (PVP-I)

Vigorously rinse with 15 ml of the 1% povidone-iodine (PVP-I) (Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA) for 30 s

Group Type ACTIVE_COMPARATOR

1% Povidone Iodine (PVP-I)

Intervention Type DRUG

Over-the-counter antiseptic mouth rinse

Hydrogen Peroxide (H2O2)

Vigorously rinse with 15 ml of the 1.5% hydrogen peroxide (H2O2) (Peroxyl; Colgate-Palmolive, Guildford, UK) for 30 s

Group Type ACTIVE_COMPARATOR

1.5% Hydrogen Peroxide (H2O2)

Intervention Type DRUG

Over-the-counter antiseptic mouth rinse

Cetylpyridinium Chloride (CPC)

Vigorously rinse with 15 ml of the 0.075% cetylpyridinium chloride (CPC) (Colgate Total; Colgate-Palmolive, Guildford, UK) for 30 s

Group Type ACTIVE_COMPARATOR

0.075% Cetylpyridinium Chloride (CPC)

Intervention Type DRUG

Over-the-counter antiseptic mouth rinse

Sodium Hypochlorite

Vigorously rinse with 15 ml of the 80 ppm sodium hypochlorite (NaOCl) (Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK) for 30 s

Group Type ACTIVE_COMPARATOR

0.1% Sodium Hypochlorite

Intervention Type DRUG

Over-the-counter antiseptic mouth rinse

No rinse group

There is no mouth rinse in this group. Patients will collect the saliva at all 4-time points without gargling with the mouth rinse.

Group Type PLACEBO_COMPARATOR

No rinse group

Intervention Type OTHER

second control group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Distilled Water

Control group

Intervention Type DRUG

1% Povidone Iodine (PVP-I)

Over-the-counter antiseptic mouth rinse

Intervention Type DRUG

1.5% Hydrogen Peroxide (H2O2)

Over-the-counter antiseptic mouth rinse

Intervention Type DRUG

0.075% Cetylpyridinium Chloride (CPC)

Over-the-counter antiseptic mouth rinse

Intervention Type DRUG

0.1% Sodium Hypochlorite

Over-the-counter antiseptic mouth rinse

Intervention Type DRUG

No rinse group

second control group

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

water (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA) Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA Peroxyl; Colgate-Palmolive, Guildford, UK Colgate Total; Colgate-Palmolive, Guildford, UK Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

MANAR ALZAHRANI

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MANAR M ALZAHRANI, MSD, FRCD(C)

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alhamra TETAMMAN clinic (PHC)

Jeddah, , Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 32047895 (View on PubMed)

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.

Reference Type RESULT
PMID: 32425001 (View on PubMed)

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.

Reference Type RESULT
PMID: 32859459 (View on PubMed)

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.

Reference Type RESULT
PMID: 33215159 (View on PubMed)

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.

Reference Type RESULT
PMID: 32326426 (View on PubMed)

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.

Reference Type RESULT
PMID: 32159775 (View on PubMed)

Bruch MK. Toxicity and safety of topical sodium hypochlorite. Contrib Nephrol. 2007;154:24-38. doi: 10.1159/000096812.

Reference Type RESULT
PMID: 17099299 (View on PubMed)

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.

Reference Type RESULT
PMID: 23017003 (View on PubMed)

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.

Reference Type RESULT
PMID: 30639191 (View on PubMed)

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.

Reference Type RESULT
PMID: 20354090 (View on PubMed)

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.

Reference Type RESULT
PMID: 31761015 (View on PubMed)

Pitten FA, Kramer A. Efficacy of cetylpyridinium chloride used as oropharyngeal antiseptic. Arzneimittelforschung. 2001;51(7):588-95. doi: 10.1055/s-0031-1300084.

Reference Type RESULT
PMID: 11505791 (View on PubMed)

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.

Reference Type RESULT
PMID: 23433693 (View on PubMed)

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.

Reference Type RESULT
PMID: 32505069 (View on PubMed)

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.

Reference Type RESULT
PMID: 11225528 (View on PubMed)

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.

Reference Type RESULT
PMID: 29633177 (View on PubMed)

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.

Reference Type RESULT
PMID: 16490989 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-02-J-002; 1384

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Double-blind, Randomized, Parallel, Placebo-controlled Clinical Study to Evaluate the Viral Load of SARS-CoV-2 (COVID-19) in the Oral Cavity of SARS-CoV-2 Positive Subjects After the Use of a Mouthwash Containing Cetylpyridinium Chloride 0,07%.
NCT04757818 COMPLETED NA
Antiviral Efficacy and Acceptability of Mouth Rinses for Inactivation of COVID-19
NCT04748783 TERMINATED PHASE2
Evaluation of the Efficacy of Mouth Rinses With Commercial Mouthwashes to Decrease Viral Load in Saliva in COVID-19 Patients
NCT05543603 COMPLETED NA
Evaluation of SARS-COV-2 Viral Load of Covid-19 Patients After Rinsing With Oral Antimicrobial Mouthwashes
NCT04902976 COMPLETED NA
Antiseptic Mouth Rinses to Reduce Salivary Viral Load in COVID-19 Patients
NCT04707742 COMPLETED NA
Pilot Study to Evaluate Effect of CHX0.12/CPC 0.05 of SARS-CoV-2 Viral Load in COVID-19 Patients
NCT04563689 COMPLETED NA
Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols
NCT02875769 COMPLETED PHASE3
Assessment of the Impact of Oral Intervention With Cetylpyridinium Chloride to Decrease SARS-CoV-2 Viral Load in Patients With COVID-19
NCT04820803 COMPLETED NA
A Four-Week Study to Measure the Effectiveness of an Experimental Mouthwash Used After Teeth Cleaning
NCT01462110 COMPLETED NA
The Efficacy of Oral Antiseptics Against COVID-19
NCT05214196 COMPLETED PHASE4
Povidone-Iodine Oral Rinse Study
NCT05239598 COMPLETED PHASE2
Salivary SARS-CoV-2 Load of Covid-19 Patients After Oral Antimicrobial Solutions and Dentifrices
NCT04537962 COMPLETED NA
Efficacy of Oral Rinses for Inactivation of COVID-19 (MOR2)
NCT05178173 COMPLETED NA
COVID-19: Nasal and Salivary Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses
NCT04352959 COMPLETED NA
Oral Rinse to Reduced Expelled Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) During COVID-19 Infection
NCT04931004 UNKNOWN PHASE1/PHASE2
Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With COVID-19
NCT04371965 COMPLETED PHASE2
A Comparison of Mouth Rinse Containing Alcohol-free Chlorhexidine With a Cetylpyridinium Chloride in Periodontal Diseases
NCT02756377 COMPLETED PHASE2/PHASE3
Effect of Mouthwash in Reducing the Symptoms Associated With Flu and Cold Viruses
NCT06479226 COMPLETED PHASE3
The Effect of Oral Antiseptic Gargles on the Oral Cavity Microbiome
NCT03141554 COMPLETED PHASE4
Clinical Effectiveness of 5 Different Mouthwashes in the Treatment of Generalised Gingivitis
NCT04733196 COMPLETED NA
Effect of Two Toothpastes on Bacteria in Saliva
NCT03587428 COMPLETED NA
Efficacy of Coconut Oil With Peppermint Essential for Oral Hygiene Routine
NCT05803109 COMPLETED NA
Gargling and Nasal Rinses to Reduce Oro- and Nasopharyngeal Viral Load in Patients With COVID-19
NCT04344236 WITHDRAWN PHASE2
Antibacterial Effect of Ozonated Olive Oil, Propolis and Chlorhexidine Mouthwashes in Pediatric Patients
NCT07197073 COMPLETED NA
Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.
NCT02194023 COMPLETED PHASE2