Subjects (125) will be randomized to one of five mouthrinses and will be asked to give a saliva sample immediately before and after a 30-60 second mouthwash. Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one hour (15, 30, 45 and 60 min). The saliva will be used for RT-PCR detection of Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) and viral infectivity assays, along with quantitative cytokine and chemokine concentration (pg/mL, Luminex). Subjects will complete a short survey on the taste and experience of using the mouthwash. Peripheral blood will be collected at the end of salivary collection. Subjects, except controls, will be provided materials and oral hygiene instruction related to daily use of oral hygiene products. In the seven-day period between study visit one and study visit two, subjects will be directed to brush with Colgate toothpaste (at least twice per day) and rinse with the Colgate mouthrinse (according to on-label procedures). Controls are asked to carry out their typical oral hygiene regimen with the products they typically use. All subjects keep a daily diary of oral hygiene performance, product usage, COVID-19 symptoms and exposures. Subjects complete study visit two one week after the baseline visit during which additional salivary (1 time point, 2 mL of saliva over 5 min, no rinse) will occur and blood samples collected. each subject will undergo a periodontal exam.
Randomized, double-blind prospective trial to test the efficacy and acceptability of
therapeutic, antiseptic mouth rinses to inactivate SARS-CoV-2 virus in saliva of SARS-CoV-2+
patients 18-65 years of age. The study will enroll 30 outpatient SARS-CoV-2+ subjects per
mouth rinse, (to achieve a total of 25 subjects with full data sets per mouth rinse,) with 5
mouth rinses, requiring us to enroll 125 SARS-CoV-2+ patients. Patients will be randomized to
their mouthrinse. These patients will have already had a confirmed SARS-CoV-2+ test prior to
enrollment. There will be no stratification to our randomization. All mouthrinses are
commercially available Colgate products and will be used according to on-label instructions.
Subjects will be randomized to a mouthrinse and will be asked to give a saliva sample
immediately before and after a 30-60 second mouthwash.
Saliva samples will be collected from subjects at 15-minute intervals thereafter up to one
hour (15, 30, 45 and 60 min). The saliva samples will be stored and used for RT-PCR detection
of SARS-CoV-2 virus and viral infectivity assays, along with quantitative cytokine and
chemokine concentration (pg/mL, Luminex).
Subjects will also complete a short survey on the taste and experience of using the
mouthwash.
Peripheral blood will be collected at the end of salivary collection. Subjects, except
controls, will be provided materials and oral hygiene instruction related to daily use of
oral hygiene products provided by the study. In the seven-day period between study visits,
subjects will be directed to brush with Colgate toothpaste (at least twice per day) and rinse
with the Colgate mouthrinse (according to on-label procedures). Controls are not given
Colgate products and will be asked to carry out their typical oral hygiene regimen with the
products they typically use. All subjects will be asked to keep a daily diary of oral hygiene
performance, product usage, COVID-19 symptoms and exposures.
Subjects will be scheduled to return to the research clinic at one week after the baseline
assessment, during which additional salivary (1 time point, 2 mL of saliva over 5 min, no
rinse will occur) and blood samples will be collected. At the conclusion of sample
collection, the subject will undergo a periodontal exam. Study participation concludes
following the periodontal exam at the end of the second on site study visit. Patients with
any periodontitis or gingivitis diagnosis will be informed of their diagnosis and will be
referred to an oral healthcare provider for further treatment. This study involves two
90-minute visits.
Other: Water
Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water.
Other Name: Sterile Water
Other: Peroxyl
Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse
Other Name: Colgate® Peroxyl® Mouth Sore Rinse
Drug: Periogard
Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.
Other Name: Colgate® PerioGard® Rinse
Other: Colgate Total Zero
Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20ml for 30 seconds
Other Name: Colgate Total® Mouthwash
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment in
the study:
- Diagnosed SARS-CoV-2+ status. Either became symptomatic in the prior 7 days, or if not
symptomatic, likely infected/exposed within the prior 7 days. All patients listed from
the University of North Carolina at Chapel Hill (UNC) Respiratory Diagnostic Center
(RDC) have a confirmed SARS-CoV-2 infection and have consented to be contacted for
research purposes. For patients contacting study coordinators for enrollment, who were
not tested in the RDC, they must provide written proof of positive SARS-CoV-2 status
in the prior 7 days.
- Individuals (all sex, all gender) at least 18 years of age and at most 65 years of age
and in good oral health without any known allergies to commercial dental products or
cosmetics. American Society of Anaesthesiologists (ASA) class I or II prior to
SARS-CoV-2 infection.
- Evidence of a personally signed and dated informed consent document indicating the
subject (or legally acceptable representative) has been informed of all pertinent
aspects of the trial and all of their questions have been answered.
- Able to comprehend and follow the requirements of the study (including availability on
scheduled visit dates) based on research site personnel's assessment.
- Females of childbearing potential will have a negative urine pregnancy test (on site)
or be physically incapable of pregnancy (implants or injections, Intrauterine device,
Bilateral tubal ligation, Hysterectomy, Ovariectomy, Women post-menopausal)
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
- Patients who have been eating or drinking within an hour of the study
- Patients under 18 years of age and older than 65 years of age
- Subjects presenting with and/or self-reporting any of the following will not be
included in the study:
- history of significant adverse effects following use of oral hygiene products
such as toothpastes and mouthrinses. (self-reported)
- Self-reported allergy to hydrogen peroxide, peroxyl, chlorhexidine gluconate,
periogard, peridex, colgate total zero, colgate total, cetylpyridinium chloride,
essential oils (Eucalyptol, Menthol, Methyl salicylate, Thymol), and other
components in the mouth rinses (methyl salicylate, ethanol, saccharin sodium,
glycerin, propylene glycol, sorbitol, Federal Food, Drug, and Cosmetic (FD&C)
blue additive no. 1, Poloxamer 407, Benzoic acid, Zinc chloride, Sodium benzoate,
Sucralose, Polyethylene Glycol (PEG-40) sorbitan diisostearate, potassium
sorbate, citric acid).
- History of serious medical conditions that, at the discretion of the
Investigator, will disqualify the subject. (Self-reported)
- A history of severe dry mouth (xerostomia), severe drug-induced xerostomia
(antidepressants, anticonvulsants, antihypertensives), or Sjogren's syndrome
- A history of recent (within the last 30 days) or current recent oral herpes flare
up, candida (thrush) infection, apthous ulcer flare up, current/active severe
periodontal disease, or other recent oral viral infection or flare up within the
past 30 days (self-reported)
- Current history of alcohol or drug abuse (self-reported).
- History of drinking water or eating food within an hour of the study visit.
- History of drinking alcohol within 12 hours of the study visit.
- History of using a commercial mouthrinse within 24 hours of the study visit.
- Participation in any study involving oral care products, concurrently or within
the previous 30 days. (self-reported)
- Positive pregnancy test reported pregnancy or lactation (this criterion is due to
oral tissue changes related to pregnancy and nursing which can affect
interpretation of study results. Additionally, women are advised to check with
their physician before using Chlorhexidine Gluconate during pregnancy and
lactation, which cannot occur in a blinded, randomized trial.)
- Other severe acute or chronic medical or psychiatric conditions or laboratory
abnormality that may increase the risk associated with trial participation or
investigational product administration or may interfere with the interpretation
of trial results and, in the judgment of the Investigator, would make the subject
inappropriate for entry into this trial.
- Patient with developmental/cognitive disability that cannot self-consent,
comprehend and follow the requirements of the study based on research site
personnel's assessment.
- Patients with sizable mucosal tears, abrasions, growths or burns in the mouth
- Patients with kidney dysfunction
Adams School of Dentistry
Chapel Hill, North Carolina, United States
Laura a Jacox, DMD, PhD, MS, Principal Investigator
University of North Carolina, Chapel Hill