SARS-CoV-2Phase 4NCT04721457
The Efficacy of Pre-procedural Mouth Rinses on COVID-19 Saliva Viral Load
A Phase 4 study testing Distilled Water, 1% Povidone Iodine (PVP-I) and 1.5% Hydrogen Peroxide (H2O2) in people with SARS-CoV-2 and COVID-19, run by King Abdulaziz University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, COVID-19, Mouthwashes
- What is being tested?
- Distilled Water, 1% Povidone Iodine (PVP-I) and 1.5% Hydrogen Peroxide (H2O2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Jan 2021to 10 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18 years or older presented to TETAMMAN clinics, Jeddah, Saudi Arabia.
- COVID-19-positive patients confirmed by RT-PCR and within two days of oral or nasopharyngeal swabs
- Asymptomatic or within seven days of the onset of symptoms.
- Has the ability to rinse and expectorate.
Who cannot join
- Participants who established antiviral, corticosteroid, antimicrobial, or immunosuppressive medications.
- Known allergy to one of the constituents of the mouth rinse
- Thyroid disease or on current radioactive iodine treatment
- Pregnant or breastfeeding women
- Lithium therapy
- History of radiotherapy or chemotherapy
- Use of mouthwash before presented to TETAMMAN clinics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mouth Rinses Efficacy on Salivary SARS-CoV-2 Viral Load: A Randomized Clinical Trial
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.
Read the detailed 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.
- Conditions
- SARS-CoV-2, COVID-19, Mouthwashes, Viral Load, Polymerase Chain Reaction, Coronavirus
- Being tested
- Distilled Water, 1% Povidone Iodine (PVP-I), 1.5% Hydrogen Peroxide (H2O2), 0.075% Cetylpyridinium Chloride (CPC), 0.1% Sodium Hypochlorite
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distilled WaterDrug
Also called water (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA)
Control group
1% Povidone Iodine (PVP-I)Drug
Also called Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA
Over-the-counter antiseptic mouth rinse
1.5% Hydrogen Peroxide (H2O2)Drug
Also called Peroxyl; Colgate-Palmolive, Guildford, UK
Over-the-counter antiseptic mouth rinse
0.075% Cetylpyridinium Chloride (CPC)Drug
Also called Colgate Total; Colgate-Palmolive, Guildford, UK
Over-the-counter antiseptic mouth rinse
0.1% Sodium HypochloriteDrug
Also called Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK
Over-the-counter antiseptic mouth rinse
No rinse groupOther
second control group
| Study group | Role | What they receive |
|---|---|---|
| Distilled Water | Placebo comparator | Vigorously rinse with 15 ml of the distilled water for 30 s (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA) Receives: Drug: Distilled Water |
| Povidone Iodine (PVP-I) | Active comparator | Vigorously rinse with 15 ml of the 1% povidone-iodine (PVP-I) (Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USA) for 30 s Receives: Drug: 1% Povidone Iodine (PVP-I) |
| Hydrogen Peroxide (H2O2) | Active comparator | Vigorously rinse with 15 ml of the 1.5% hydrogen peroxide (H2O2) (Peroxyl; Colgate-Palmolive, Guildford, UK) for 30 s Receives: Drug: 1.5% Hydrogen Peroxide (H2O2) |
| Cetylpyridinium Chloride (CPC) | Active comparator | Vigorously rinse with 15 ml of the 0.075% cetylpyridinium chloride (CPC) (Colgate Total; Colgate-Palmolive, Guildford, UK) for 30 s Receives: Drug: 0.075% Cetylpyridinium Chloride (CPC) |
| Sodium Hypochlorite | Active comparator | Vigorously rinse with 15 ml of the 80 ppm sodium hypochlorite (NaOCl) (Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK) for 30 s Receives: Drug: 0.1% Sodium Hypochlorite |
| No rinse group | Placebo comparator | There is no mouth rinse in this group. Patients will collect the saliva at all 4-time points without gargling with the mouth rinse. Receives: Other: No rinse group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (T0) vs 5 minutes (T1), baseline (T0) vs 30 minutes (T2), and baseline (T0) vs 60 minutes T3)
Compare salivary viral load between mouth rinse groups and controls at baseline
Difference in Salivary viral load baseline value between the groups
Measured: Compare Baseline (T0)
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
Measured: 5 minutes post rinsing (T1)
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
Measured: 30 minutes post rinsing (T2)
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
Measured: 60 minutes post rinsing (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start3 Jan 2021
- Primary completion28 Mar 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MANAR ALZAHRANI, King Abdulaziz University
- Investigators
- MANAR M ALZAHRANI, MSD, FRCD(C), Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721457
- Sponsor's protocol ID
- H-02-J-002; 1384
- Status last verified
- Jul 2022
- First submitted
- 19 Jan 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32047895Ge 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.
PubMed 32425001Vergara-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.
PubMed 32859459O'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.
PubMed 33215159Carrouel 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.
PubMed 32326426Wang 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.
PubMed 32159775Bruch MK. Toxicity and safety of topical sodium hypochlorite. Contrib Nephrol. 2007;154:24-38. doi: 10.1159/000096812.
PubMed 17099299De 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.
PubMed 23017003Seo 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.
PubMed 30639191Feres 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.
PubMed 20354090Marui 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.
PubMed 31761015Pitten FA, Kramer A. Efficacy of cetylpyridinium chloride used as oropharyngeal antiseptic. Arzneimittelforschung. 2001;51(7):588-95. doi: 10.1055/s-0031-1300084.
PubMed 11505791Osso 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.
PubMed 23433693Caruso 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.
PubMed 32505069Walsh 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.
PubMed 11225528
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mouth Rinses Efficacy on Salivary SARS-CoV-2 Viral Load: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04721457
- Acronym / sponsor ID
- H-02-J-002; 1384
- Conditions
- SARS-CoV-2, COVID-19, Mouthwashes, Viral Load, Polymerase Chain Reaction, Coronavirus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 28 Mar 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Distilled Water | Placebo comparator | Drug: Distilled WaterVigorously rinse with 15 ml of the distilled water for 30 s (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA) |
| Povidone Iodine (PVP-I) | Active comparator | Drug: 1% 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 |
| Hydrogen Peroxide (H2O2) | Active comparator | Drug: 1.5% Hydrogen Peroxide (H2O2)Vigorously rinse with 15 ml of the 1.5% hydrogen peroxide (H2O2) (Peroxyl; Colgate-Palmolive, Guildford, UK) for 30 s |
| Cetylpyridinium Chloride (CPC) | Active comparator | Drug: 0.075% Cetylpyridinium Chloride (CPC)Vigorously rinse with 15 ml of the 0.075% cetylpyridinium chloride (CPC) (Colgate Total; Colgate-Palmolive, Guildford, UK) for 30 s |
| Sodium Hypochlorite | Active comparator | Drug: 0.1% Sodium HypochloriteVigorously rinse with 15 ml of the 80 ppm sodium hypochlorite (NaOCl) (Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UK) for 30 s |
| No rinse group | Placebo comparator | Other: No rinse groupThere is no mouth rinse in this group. Patients will collect the saliva at all 4-time points without gargling with the mouth rinse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age 18 years or older presented to TETAMMAN clinics, Jeddah, Saudi Arabia.
- COVID-19-positive patients confirmed by RT-PCR and within two days of oral or nasopharyngeal swabs
- Asymptomatic or within seven days of the onset of symptoms.
- Has the ability to rinse and expectorate.
Key exclusion criteria (7 listed)
- Participants who established antiviral, corticosteroid, antimicrobial, or immunosuppressive medications.
- Known allergy to one of the constituents of the mouth rinse
- Thyroid disease or on current radioactive iodine treatment
- Pregnant or breastfeeding women
- Lithium therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distilled WaterAlso: water (Water for Injections BP; Pharmaceutical Solutions Industry, Jeddah, SA)Control group | Drug | Distilled Water |
| 1% Povidone Iodine (PVP-I)Also: Betadine Mouthwash/Gargle; Avrio Health LP, Stamford, CT, USAOver-the-counter antiseptic mouth rinse | Drug | Povidone Iodine (PVP-I) |
| 1.5% Hydrogen Peroxide (H2O2)Also: Peroxyl; Colgate-Palmolive, Guildford, UKOver-the-counter antiseptic mouth rinse | Drug | Hydrogen Peroxide (H2O2) |
| 0.075% Cetylpyridinium Chloride (CPC)Also: Colgate Total; Colgate-Palmolive, Guildford, UKOver-the-counter antiseptic mouth rinse | Drug | Cetylpyridinium Chloride (CPC) |
| 0.1% Sodium HypochloriteAlso: Clinisept Dental Mouthwash; Clinical Health Technologies, Hinckley, Leicestershire, UKOver-the-counter antiseptic mouth rinse | Drug | Sodium Hypochlorite |
| No rinse groupsecond control group | Other | No rinse group |
Primary outcome
Change in the salivary viral load within each mouth rinse groups and controls
Time frame: Baseline (T0) vs 5 minutes (T1), baseline (T0) vs 30 minutes (T2), and baseline (T0) vs 60 minutes T3)
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
Compare salivary viral load between mouth rinse groups and controls at baseline
Time frame: Compare Baseline (T0)
Difference in Salivary viral load baseline value between the groups
Compare salivary viral load between mouth rinse groups and controls at 5 minutes post rinsing
Time frame: 5 minutes post rinsing (T1)
Difference in Salivary viral load baseline value between the groups
Compare salivary viral load between mouth rinse groups and controls at 30 minutes post rinsing
Time frame: 30 minutes post rinsing (T2)
Difference in Salivary viral load baseline value between the groups
Compare salivary viral load between mouth rinse groups and controls at 60 minutes post rinsing
Time frame: 60 minutes post rinsing (T3)
Difference in Salivary viral load baseline value between the groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Results publication: PubMed 32047895To 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.
- Results publication: PubMed 32425001Ge 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.
- Results publication: PubMed 32859459Vergara-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.
- Results publication: PubMed 33215159O'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.
- Results publication: PubMed 32326426Carrouel 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.
- Results publication: PubMed 32159775Wang 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.
- Results publication: PubMed 17099299Bruch MK. Toxicity and safety of topical sodium hypochlorite. Contrib Nephrol. 2007;154:24-38. doi: 10.1159/000096812.
- Results publication: PubMed 23017003De 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.
- Results publication: PubMed 30639191Seo 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.
- Results publication: PubMed 20354090Feres 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.
- Results publication: PubMed 31761015Marui 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.
- Results publication: PubMed 11505791Pitten FA, Kramer A. Efficacy of cetylpyridinium chloride used as oropharyngeal antiseptic. Arzneimittelforschung. 2001;51(7):588-95. doi: 10.1055/s-0031-1300084.
- Individual participant dataSharing planned: No
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A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MANAR M ALZAHRANI, MSD, FRCD(C) principal investigator
King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Distilled Water, 1% Povidone Iodine (PVP-I) and 1.5% Hydrogen Peroxide (H2O2) in people with SARS-CoV-2 and COVID-19, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the salivary viral load within each mouth rinse groups and controls (time frame: Baseline (T0) vs 5 minutes (T1), baseline (T0) vs 30 minutes (T2), and baseline (T0) vs 60 minutes T3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04721457, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.