COVID-19Phase 4NCT04603794
Efficacy of Mouthwash in Reducing Salivary Carriage of COVID-19
A Phase 4 study testing 0.5% Povidone Iodine, 0.12% Chlorhexidine Gluconate Mouth Rinse and 1% Hydrogen Peroxide in people with COVID-19, run by Ohio State University at 1 site in United States.
Trial summary
Researchers know that the virus that causes COVID-19 has been found in the saliva (spit) of individuals who exhibit signs of the disease. Investigators would like to test the ability of three mouthwashes to reduce the levels of this virus in participants' mouths. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- 0.5% Povidone Iodine, 0.12% Chlorhexidine Gluconate Mouth Rinse and 1% Hydrogen Peroxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to Nov 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults age 18-80 admitted to The Ohio State University Medical Center,
- diagnosis of COVID-19 confirmed by Polymerase Chain Reaction (PCR),
- salivary carriage of COVID-19 virus
- ability to perform mouthwash rinses and to expectorate.
Who cannot join
- allergy to any study mouth rinse,
- active uncontrolled thyroid disease,
- pregnancy
- patients undergoing radioactive iodine therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
David L Hall, DDS, 614-292-2622, hall.611@osu.edu
Purnima Kumar, PhD,DDS, 614-804-2112, kumar.83@osu.edu
About this study
Official title: Comparison of Normal Saline, Hydrogen Peroxide, Chlorhexidine and Povidone-Iodine Mouth Rinses in COVID-19 Patients
Researchers know that the virus that causes COVID-19 has been found in the saliva (spit) of individuals who exhibit signs of the disease. Investigators would like to test the ability of three mouthwashes to reduce the levels of this virus in participants' mouths. Investigators will ask participants to use a liquid to swish around in the mouth for 30 seconds and spit it into a collection cup. Investigators will also collect spit from participants before and after participants use the mouthwash. Although participants will have no direct benefits from the study, investigators will gain a wealth of information that would benefit patients who are at risk for COVID-19.
Read the detailed description
Project aims:
Aim 1: To examine the salivary carriage of COVID-19 in individuals before and after use of mouthwashes known to reduce oral microbiota, using real time reverse transcriptase quantitative PCR (Polymerase Chain Reaction) to quantify viral load.
RESEARCH STRATEGY:
- Recruitment and baseline data:
This is a cross-sectional interventional 4 arm study. 60 subjects between 18-80 years of age will be recruited from those who are being treated for COVID-19 at the Ohio State University Medical Center. There is no data upon which to base sample size estimates, and investigators have landed on this number in an effort to obtain a representative sample of Ohio's population. If the potential subject is interested in participating, the study coordinator will collect contact information from the candidate and the consent form will be presented to these individuals. Subjects will be allowed sufficient time to read and ask questions, and once sign these forms, a detailed history including information about ethnicity, education, income, age, sex, race, medical status (including pregnancy) and dental history will be elicited. Subjects will self-collect saliva in a 5 ml collection tube, following which they will be asked to use one of 3 mouthwashes (chlorhexidine, povidone iodine, hydrogen peroxide or control(saline) for thirty seconds and spit them into collection tubes. Investigators will use Peridex, Hydrogen Peroxide and Betadine, which are commercially available formulations of chlorhexidine, hydrogen peroxide and betadine respectively, to reduce formulation bias. Investigators have attached the product labels as appendices to this proposal. The exact mouthwash will be decided by random chance using a random number generator. Investigators have generated the following randomization schedule using Microsoft excel: Each subject will be assigned a number as they are recruited (E.g. first patient to sign the consent will be patient 1, and the second will be patient 2 and so on). Patients 1 and 2 will receive saline and 3 will receive chlorhexidine etc. base on the above randomization schedule. Subjects will then collect saliva in separate collection tubes 15 and 30 minutes after rinsing.
- Sample collection Saliva will be collected using a methodology described by previous investigators. Briefly, subjects will be asked to collect saliva in their mouth for 3 minutes and then continuously drool into a tube for 3 minutes. This method will allow investigators to collect unstimulated saliva. Saliva will be collected using kits containing RNA (Ribonucleic Acid) stabilizer (Oragen RNA kit).
- Measurement / Instrumentation
Total RNA will be isolated from saliva using the mirVana miRNA (Messenger Ribonucleic Acid) isolation kit (Applied Biosystems). Microbial cells will be lysed and RNA will be extracted by Acid-Phenol:Chloroform and ethanol precipitation and eluted in nuclease-free water. Investigators will use well validated primers to quantify copy numbers of COVID-19 spike protein mRNA (Messenger Ribonucleic Acid) from the saliva. For an absolute quantification of COVID-19, investigators will use one step RT-PCR (Reverse Transcriptase) assay by using an appropriate commercially available kit. In this step investigators will convert mRNA to cDNA (complementary Deoxyribonucleic Acid) and then quantify the cDNA by using targeted primers and then copy numbers of the COVID-19 will be calculated by comparing ct (cycle threshold)Values samples against standard curve. In order to generate standard curves for absolute quantification, target genes will be amplified with PCR. The PCR products will be cloned into suitable vector. Then plasmids will be extracted, serially diluted, and used as templates in qPCR (quantitative polymerase chain reaction) for generating standard curves.
- Internal Validity Subjects will be recruited randomly through voluntary participation. This will eliminate presentation bias.
- Data Analysis
Descriptive statistics will be provided as estimates of salivary carriage of COVID-19. Frequency of salivary carriage of the virus will be expressed as a percent of the total sample population. Reduction in COVID-19 following mouthwash use will be expressed as fold change and compared between the three mouthwash groups using parametric tests.
- Conditions
- COVID-19
- Being tested
- 0.5% Povidone Iodine, 0.12% Chlorhexidine Gluconate Mouth Rinse, 1% Hydrogen Peroxide, 0.9% Normal Saline
- Keywords
- Mouthwashes, COVID-19, Salivary Carriage, Povidone-Iodine, PCR (Polymerase Chain Reaction), Dental Aerosols
- Medical subject headings
- COVID-19, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% Povidone IodineDrug
Also called Betadine Mouthwash
Commercially Available Mouth Rinses and Over the Counter Standard Formulations
0.12% Chlorhexidine Gluconate Mouth RinseDrug
Also called Peridex
Commercially Available Mouth Rinses
1% Hydrogen PeroxideDrug
Also called Hydrogen Peroxide
Commercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia)
0.9% Normal SalineDrug
Also called Salt Water
Commercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia)
| Study group | Role | What they receive |
|---|---|---|
| 1% Hydrogen Peroxide Mouth Rinse | Active comparator | 30 second oral rinse with 1% Hydrogen Peroxide Receives: Drug: 1% Hydrogen Peroxide |
| 0.12% Chlorhexidine Gluconate Mouth Rinse | Active comparator | 30 second oral rinse with 0.12% Chlorhexidine Gluconate Receives: Drug: 0.12% Chlorhexidine Gluconate Mouth Rinse |
| 0.5% Povidone Iodine Mouth Rinse | Active comparator | 30 second oral rinse with 0.5% Povidone Iodine Mouth wash Receives: Drug: 0.5% Povidone Iodine |
| 0.9% Normal Saline Mouth Rinse | Placebo comparator | 30 second oral rinse with 0.9% Normal Saline Receives: Drug: 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
real time reverse transcriptase quantitative PCR
Saliva load was expressed in copies x 10 8 of COVID-19 RNA
Measured: 3 measurements of changes from times 0 minutes. vs:15 minutes, and vs: 45 minutes during a single session
ct values
cycle thresholds
Measured: 3 measurements of changes from times 0 minutes.vs:15 minutes, and vs:45 minutes during a single session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Oct 2020
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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 randomized, cross-sectional, double blinded, negative controlled, four armed, prospective, interventional study compared Normal Saline, Hydrogen Peroxide, Chlorhexidine and Povidone-Iodine Mouth Rinses in 60 subjects being treated for Covid 19 at the The Ohio State University Medical Center. Real time reverse transcriptase quantitative PCR measured viral loads.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hall, Ohio State University
- Investigators
- David L Hall, DDS, Study director, The Ohio State University College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603794
- Sponsor's protocol ID
- 2020H0346
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: As per The Ohio State University Office for Responsible Research Practices (Human Studies IRB)
Publications
Serban D, Banu A, Serban C, Tuta-Sas I, Vlaicu B. Predictors of quantitative microbiological analysis of spatter and aerosolization during scaling. Rev Med Chir Soc Med Nat Iasi. 2013 Apr-Jun;117(2):503-8.
PubMed 24340537Gupta G, Mitra D, Ashok KP, Gupta A, Soni S, Ahmed S, Arya A. Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study. J Periodontol. 2014 Apr;85(4):562-8. doi: 10.1902/jop.2013.120616. Epub 2013 Jul 15.
PubMed 23855840Shetty SK, Sharath K, Shenoy S, Sreekumar C, Shetty RN, Biju T. Compare the effcacy of two commercially available mouthrinses in reducing viable bacterial count in dental aerosol produced during ultrasonic scaling when used as a preprocedural rinse. J Contemp Dent Pract. 2013 Sep 1;14(5):848-51. doi: 10.5005/jp-journals-10024-1414.
PubMed 24685786Devker NR, Mohitey J, Vibhute A, Chouhan VS, Chavan P, Malagi S, Joseph R. A study to evaluate and compare the efficacy of preprocedural mouthrinsing and high volume evacuator attachment alone and in combination in reducing the amount of viable aerosols produced during ultrasonic scaling procedure. J Contemp Dent Pract. 2012 Sep 1;13(5):681-9. doi: 10.5005/jp-journals-10024-1209.
PubMed 23250175Klyn SL, Cummings DE, Richardson BW, Davis RD. Reduction of bacteria-containing spray produced during ultrasonic scaling. Gen Dent. 2001 Nov-Dec;49(6):648-52.
PubMed 12024755Wirthlin MR, Choi JH, Kye SB. Use of chlorine dioxide mouthrinse as the ultrasonic scaling lavage reduces the viable bacteria in the generated aerosols. J West Soc Periodontol Periodontal Abstr. 2006;54(2):35-44. No abstract available.
PubMed 17214015Peng X, Xu X, Li Y, Cheng L, Zhou X, Ren B. Transmission routes of 2019-nCoV and controls in dental practice. Int J Oral Sci. 2020 Mar 3;12(1):9. doi: 10.1038/s41368-020-0075-9.
PubMed 32127517Navazesh M. Methods for collecting saliva. Ann N Y Acad Sci. 1993 Sep 20;694:72-7. doi: 10.1111/j.1749-6632.1993.tb18343.x. No abstract available.
PubMed 8215087To 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 32047895Chaudhary P, Melkonyan A, Meethil A, Saraswat S, Hall DL, Cottle J, Wenzel M, Ayouty N, Bense S, Casanova F, Chaney M, Chase H, Hermel R, McClement M, Sesson C, Woolsey B, Kumar P. Estimating salivary carriage of severe acute respiratory syndrome coronavirus 2 in nonsymptomatic people and efficacy of mouthrinse in reducing viral load: A randomized controlled trial. J Am Dent Assoc. 2021 Nov;152(11):903-908. doi: 10.1016/j.adaj.2021.05.021. Epub 2021 Jun 11.
PubMed 34561086
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Normal Saline, Hydrogen Peroxide, Chlorhexidine and Povidone-Iodine Mouth Rinses in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04603794
- Acronym / sponsor ID
- 2020H0346
- Conditions
- COVID-19
- Keywords
- Mouthwashes, COVID-19, Salivary Carriage, Povidone-Iodine, PCR (Polymerase Chain Reaction), Dental Aerosols
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 27 Oct 2020 (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.
Researchers know that the virus that causes COVID-19 has been found in the saliva (spit) of individuals who exhibit signs of the disease. Investigators would like to test the ability of three mouthwashes to reduce the levels of this virus in participants' mouths. Investigators will ask participants to use a liquid to swish around in the mouth for 30 seconds and spit it into a collection cup. Investigators will also collect spit from participants before and after participants use the mouthwash. Although participants will have no direct benefits from the study, investigators will gain a wealth of information that would benefit patients who are at risk for COVID-19.
Detailed description
Project aims:
Aim 1: To examine the salivary carriage of COVID-19 in individuals before and after use of mouthwashes known to reduce oral microbiota, using real time reverse transcriptase quantitative PCR (Polymerase Chain Reaction) to quantify viral load.
RESEARCH STRATEGY:
- Recruitment and baseline data:
This is a cross-sectional interventional 4 arm study. 60 subjects between 18-80 years of age will be recruited from those who are being treated for COVID-19 at the Ohio State University Medical Center. There is no data upon which to base sample size estimates, and investigators have landed on this number in an effort to obtain a representative sample of Ohio's population. If the potential subject is interested in participating, the study coordinator will collect contact information from the candidate and the consent form will be presented to these individuals. Subjects will be allowed sufficient time to read and ask questions, and once sign these forms, a detailed history including information about ethnicity, education, income, age, sex, race, medical status (including pregnancy) and dental history will be elicited. Subjects will self-collect saliva in a 5 ml collection tube, following which they will be asked to use one of 3 mouthwashes (chlorhexidine, povidone iodine, hydrogen peroxide or control(saline) for thirty seconds and spit them into collection tubes. Investigators will use Peridex, Hydrogen Peroxide and Betadine, which are commercially available formulations of chlorhexidine, hydrogen peroxide and betadine respectively, to reduce formulation bias. Investigators have attached the product labels as appendices to this proposal. The exact mouthwash will be decided by random chance using a random number generator. Investigators have generated the following randomization schedule using Microsoft excel: Each subject will be assigned a number as they are recruited (E.g. first patient to sign the consent will be patient 1, and the second will be patient 2 and so on). Patients 1 and 2 will receive saline and 3 will receive chlorhexidine etc. base on the above randomization schedule. Subjects will then collect saliva in separate collection tubes 15 and 30 minutes after rinsing.
- Sample collection Saliva will be collected using a methodology described by previous investigators. Briefly, subjects will be asked to collect saliva in their mouth for 3 minutes and then continuously drool into a tube for 3 minutes. This method will allow investigators to collect unstimulated saliva. Saliva will be collected using kits containing RNA (Ribonucleic Acid) stabilizer (Oragen RNA kit).
- Measurement / Instrumentation
Total RNA will be isolated from saliva using the mirVana miRNA (Messenger Ribonucleic Acid) isolation kit (Applied Biosystems). Microbial cells will be lysed and RNA will be extracted by Acid-Phenol:Chloroform and ethanol precipitation and eluted in nuclease-free water. Investigators will use well validated primers to quantify copy numbers of COVID-19 spike protein mRNA (Messenger Ribonucleic Acid) from the saliva. For an absolute quantification of COVID-19, investigators will use one step RT-PCR (Reverse Transcriptase) assay by using an appropriate commercially available kit. In this step investigators will convert mRNA to cDNA (complementary Deoxyribonucleic Acid) and then quantify the cDNA by using targeted primers and then copy numbers of the COVID-19 will be calculated by comparing ct (cycle threshold)Values samples against standard curve. In order to generate standard curves for absolute quantification, target genes will be amplified with PCR. The PCR products will be cloned into suitable vector. Then plasmids will be extracted, serially diluted, and used as templates in qPCR (quantitative polymerase chain reaction) for generating standard curves.
- Internal Validity Subjects will be recruited randomly through voluntary participation. This will eliminate presentation bias.
- Data Analysis
Descriptive statistics will be provided as estimates of salivary carriage of COVID-19. Frequency of salivary carriage of the virus will be expressed as a percent of the total sample population. Reduction in COVID-19 following mouthwash use will be expressed as fold change and compared between the three mouthwash groups using parametric tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This randomized, cross-sectional, double blinded, negative controlled, four armed, prospective, interventional study compared Normal Saline, Hydrogen Peroxide, Chlorhexidine and Povidone-Iodine Mouth Rinses in 60 subjects being treated for Covid 19 at the The Ohio State University Medical Center. Real time reverse transcriptase quantitative PCR measured viral loads.
| Arm | Type | Receives |
|---|---|---|
| 1% Hydrogen Peroxide Mouth Rinse | Active comparator | Drug: 1% Hydrogen Peroxide30 second oral rinse with 1% Hydrogen Peroxide |
| 0.12% Chlorhexidine Gluconate Mouth Rinse | Active comparator | Drug: 0.12% Chlorhexidine Gluconate Mouth Rinse30 second oral rinse with 0.12% Chlorhexidine Gluconate |
| 0.5% Povidone Iodine Mouth Rinse | Active comparator | Drug: 0.5% Povidone Iodine30 second oral rinse with 0.5% Povidone Iodine Mouth wash |
| 0.9% Normal Saline Mouth Rinse | Placebo comparator | Drug: 0.9% Normal Saline30 second oral rinse with 0.9% Normal Saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults age 18-80 admitted to The Ohio State University Medical Center,
- diagnosis of COVID-19 confirmed by Polymerase Chain Reaction (PCR),
- salivary carriage of COVID-19 virus
- ability to perform mouthwash rinses and to expectorate.
Key exclusion criteria (4 listed)
- allergy to any study mouth rinse,
- active uncontrolled thyroid disease,
- pregnancy
- patients undergoing radioactive iodine 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 |
|---|---|---|
| 0.5% Povidone IodineAlso: Betadine MouthwashCommercially Available Mouth Rinses and Over the Counter Standard Formulations | Drug | 0.5% Povidone Iodine Mouth Rinse |
| 0.12% Chlorhexidine Gluconate Mouth RinseAlso: PeridexCommercially Available Mouth Rinses | Drug | 0.12% Chlorhexidine Gluconate Mouth Rinse |
| 1% Hydrogen PeroxideAlso: Hydrogen PeroxideCommercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia) | Drug | 1% Hydrogen Peroxide Mouth Rinse |
| 0.9% Normal SalineAlso: Salt WaterCommercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia) | Drug | 0.9% Normal Saline Mouth Rinse |
Primary outcome
real time reverse transcriptase quantitative PCR
Time frame: 3 measurements of changes from times 0 minutes. vs:15 minutes, and vs: 45 minutes during a single session
Saliva load was expressed in copies x 10 8 of COVID-19 RNA
ct values
Time frame: 3 measurements of changes from times 0 minutes.vs:15 minutes, and vs:45 minutes during a single session
cycle thresholds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Background: PubMed 24340537Serban D, Banu A, Serban C, Tuta-Sas I, Vlaicu B. Predictors of quantitative microbiological analysis of spatter and aerosolization during scaling. Rev Med Chir Soc Med Nat Iasi. 2013 Apr-Jun;117(2):503-8.
- Background: PubMed 23855840Gupta G, Mitra D, Ashok KP, Gupta A, Soni S, Ahmed S, Arya A. Efficacy of preprocedural mouth rinsing in reducing aerosol contamination produced by ultrasonic scaler: a pilot study. J Periodontol. 2014 Apr;85(4):562-8. doi: 10.1902/jop.2013.120616. Epub 2013 Jul 15.
- Background: PubMed 24685786Shetty SK, Sharath K, Shenoy S, Sreekumar C, Shetty RN, Biju T. Compare the effcacy of two commercially available mouthrinses in reducing viable bacterial count in dental aerosol produced during ultrasonic scaling when used as a preprocedural rinse. J Contemp Dent Pract. 2013 Sep 1;14(5):848-51. doi: 10.5005/jp-journals-10024-1414.
- Background: PubMed 23250175Devker NR, Mohitey J, Vibhute A, Chouhan VS, Chavan P, Malagi S, Joseph R. A study to evaluate and compare the efficacy of preprocedural mouthrinsing and high volume evacuator attachment alone and in combination in reducing the amount of viable aerosols produced during ultrasonic scaling procedure. J Contemp Dent Pract. 2012 Sep 1;13(5):681-9. doi: 10.5005/jp-journals-10024-1209.
- Background: PubMed 12024755Klyn SL, Cummings DE, Richardson BW, Davis RD. Reduction of bacteria-containing spray produced during ultrasonic scaling. Gen Dent. 2001 Nov-Dec;49(6):648-52.
- Background: PubMed 17214015Wirthlin MR, Choi JH, Kye SB. Use of chlorine dioxide mouthrinse as the ultrasonic scaling lavage reduces the viable bacteria in the generated aerosols. J West Soc Periodontol Periodontal Abstr. 2006;54(2):35-44. No abstract available.
- Background: PubMed 32127517Peng X, Xu X, Li Y, Cheng L, Zhou X, Ren B. Transmission routes of 2019-nCoV and controls in dental practice. Int J Oral Sci. 2020 Mar 3;12(1):9. doi: 10.1038/s41368-020-0075-9.
- Background: PubMed 8215087Navazesh M. Methods for collecting saliva. Ann N Y Acad Sci. 1993 Sep 20;694:72-7. doi: 10.1111/j.1749-6632.1993.tb18343.x. No abstract available.
- Background: 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.
- Derived from this study: PubMed 34561086Chaudhary P, Melkonyan A, Meethil A, Saraswat S, Hall DL, Cottle J, Wenzel M, Ayouty N, Bense S, Casanova F, Chaney M, Chase H, Hermel R, McClement M, Sesson C, Woolsey B, Kumar P. Estimating salivary carriage of severe acute respiratory syndrome coronavirus 2 in nonsymptomatic people and efficacy of mouthrinse in reducing viral load: A randomized controlled trial. J Am Dent Assoc. 2021 Nov;152(11):903-908. doi: 10.1016/j.adaj.2021.05.021. Epub 2021 Jun 11.
- Povidone-iodine demonstrates rapid in-vitro Activity...Link provided by the sponsor.
- Viral dynamics in asymptomatic patients with COVID-19Link provided by the sponsor.
- Individual participant dataSharing planned: No. As per The Ohio State University Office for Responsible Research Practices (Human Studies IRB)
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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.
David L Hall, DDS study director
The Ohio State University College of Dentistry
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 0.5% Povidone Iodine, 0.12% Chlorhexidine Gluconate Mouth Rinse and 1% Hydrogen Peroxide in people with COVID-19, run by Ohio State University at 1 site in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 27 Oct 2020. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David L Hall, DDS (614-292-2622, hall.611@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
real time reverse transcriptase quantitative PCR (time frame: 3 measurements of changes from times 0 minutes. vs:15 minutes, and vs: 45 minutes during a single session). The study lists 2 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 NCT04603794, which also lists 10 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 27 Oct 2020.