Mouth Rinses for Inactivation of COVID-19 (MOR)
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ClinicalTrials.gov Identifier: NCT04584684 |
Recruitment Status :
Terminated
(The team decided to terminate the trial in order to start a new trial, unrelated to safety reasons)
First Posted : October 14, 2020
Results First Posted : March 25, 2024
Last Update Posted : March 25, 2024
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Covid19 Coronavirus Infection SARS-CoV-2 Infection |
Interventions |
Other: 0.9% w/v NaCL Saline Drug: 1.5% w/v Hydrogen Peroxide Drug: 0.12% Chlorohexidine Gluconate Drug: 27% Ethanol plus essential oils Drug: 0.5% w/v Povidone-iodide Drug: 0.075% Cetylpyridinium Chloride |
Enrollment | 128 |
Recruitment Details | |
Pre-assignment Details | One participant who signed informed consent was unable to provide an adequate amount of saliva at Baseline and subsequently withdrew from the study. |
Arm/Group Title | 0.9% w/v NaCl | 27% Ethanol Plus Essential Oils | 0.075% Cetylpyridinium Chloride | 1.5% w/v Hydrogen Peroxide | 0.5% w/v Povidone-iodide | 0.12% Chlorhexidine Gluconate |
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Arm/Group Description |
Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.9% w/v NaCl. 0.9% w/v NaCl: Saline placebo rinse |
Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils. 27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse |
Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride. 0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse |
Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse. 1.5% w/v Hydrogen Peroxide: Over-the-counter antiseptic mouth rinse |
Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide. 0.5% w/v Povidone-iodide: Over-the-counter antiseptic mouth rinse |
Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate. 0.12% Chlorohexidine Gluconate: Dentist prescribed antimicrobial mouth rinse |
Period Title: Overall Study | ||||||
Started | 21 | 27 | 22 | 19 | 20 | 19 |
Completed | 21 | 27 | 22 | 19 | 19 | 19 |
Not Completed | 0 | 0 | 0 | 0 | 1 | 0 |
Arm/Group Title | 0.9% w/v NaCl | 27% Ethanol Plus Essential Oils | 0.075% Cetylpyridinium Chloride | 1.5% w/v Hydrogen Peroxide | 0.5% w/v Povidone-iodide | 0.12% Chlorhexidine Gluconate | Total | |
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Arm/Group Description |
Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.9% w/v NaCl. 0.9% w/v NaCl: Saline placebo rinse |
Subject participants will rinse mouth one time for 60 seconds with 10 mL 27% ethanol plus essential oils. 27% Ethanol plus essential oils: Over-the-counter antiseptic mouth rinse |
Subject participants will rinse mouth one time for 60 seconds with 10 mL 0.075% Cetylpyridinium Chloride. 0.075% Cetylpyridinium Chloride: Over-the-counter antiseptic mouth rinse |
Subject participants will rinse mouth one time for 60 seconds with 10 mL of 1.5% w/v hydrogen peroxide rinse. 1.5% w/v Hydrogen Peroxide: Over-the-counter antiseptic mouth rinse |
Subject participants will rinse mouth one time for 60 seconds with 10 mL .5% w/v povidone-iodide. 0.5% w/v Povidone-iodide: Over-the-counter antiseptic mouth rinse |
Subject participants will rinse mouth one time for 60 seconds with 10 mL of 0.12% Chlorhexidine Gluconate. 0.12% Chlorohexidine Gluconate: Dentist prescribed antimicrobial mouth rinse |
Total of all reporting groups | |
Overall Number of Baseline Participants | 21 | 27 | 22 | 19 | 20 | 19 | 128 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 21 participants | 27 participants | 22 participants | 19 participants | 20 participants | 19 participants | 128 participants | |
<=18 years |
2 9.5%
|
0 0.0%
|
1 4.5%
|
0 0.0%
|
0 0.0%
|
0 0.0%
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3 2.3%
|
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Between 18 and 65 years |
19 90.5%
|
27 100.0%
|
20 90.9%
|
19 100.0%
|
20 100.0%
|
19 100.0%
|
124 96.9%
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>=65 years |
0 0.0%
|
0 0.0%
|
1 4.5%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 0.8%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 21 participants | 27 participants | 22 participants | 19 participants | 20 participants | 19 participants | 128 participants | |
Female |
12 57.1%
|
18 66.7%
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13 59.1%
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10 52.6%
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11 55.0%
|
10 52.6%
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74 57.8%
|
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Male |
9 42.9%
|
9 33.3%
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9 40.9%
|
9 47.4%
|
9 45.0%
|
9 47.4%
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54 42.2%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 21 participants | 27 participants | 22 participants | 19 participants | 20 participants | 19 participants | 128 participants | |
Hispanic or Latino |
2 9.5%
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2 7.4%
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3 13.6%
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1 5.3%
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2 10.0%
|
1 5.3%
|
11 8.6%
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Not Hispanic or Latino |
19 90.5%
|
25 92.6%
|
19 86.4%
|
18 94.7%
|
18 90.0%
|
18 94.7%
|
117 91.4%
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|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 21 participants | 27 participants | 22 participants | 19 participants | 20 participants | 19 participants | 128 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
2 9.1%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
2 1.6%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
2 9.5%
|
8 29.6%
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2 9.1%
|
2 10.5%
|
3 15.0%
|
3 15.8%
|
20 15.6%
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|
White |
18 85.7%
|
19 70.4%
|
18 81.8%
|
17 89.5%
|
16 80.0%
|
16 84.2%
|
104 81.3%
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More than one race |
1 4.8%
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0 0.0%
|
0 0.0%
|
0 0.0%
|
1 5.0%
|
0 0.0%
|
2 1.6%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 21 participants | 27 participants | 22 participants | 19 participants | 20 participants | 19 participants | 128 participants |
21 100.0%
|
27 100.0%
|
22 100.0%
|
19 100.0%
|
20 100.0%
|
19 100.0%
|
128 100.0%
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Name/Title: | Laura Jacox, DMD, PhD, MS |
Organization: | University of North Carolina at Chapel Hill |
Phone: | 847-702-0988 |
EMail: | ljacox@live.unc.edu |
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT04584684 |
Other Study ID Numbers: |
20-2040 |
First Submitted: | October 9, 2020 |
First Posted: | October 14, 2020 |
Results First Submitted: | January 27, 2023 |
Results First Posted: | March 25, 2024 |
Last Update Posted: | March 25, 2024 |