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Trial details
In vivo evaluation of the virucidal efficacy of Chlorhexidine and Povidone-iodine mouthwashes against salivary SARS-CoV-2
Current status:
Approved
|
Date registered:
06/03/2021
Trial version(s)
History: 06/03/2021
Current: 06/03/2021
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Main Information
Primary registry identifying number
LBCTR2021034768
Protocol number
CUER132020
MOH registration number
N/A
Trial already registered with the MoPH
Study registered at the country of origin
Lebanon
Type of registration
Retrospective
Type of registration: Justify
Research team was not aware of existence of LBCTR.
Date of registration in national regulatory agency
29/04/2020
Primary sponsor
Lebanese University
Primary sponsor: Country of origin
Lebanon
Public title
In vivo evaluation of the virucidal efficacy of Chlorhexidine and Povidone-iodine mouthwashes against salivary SARS-CoV-2
Acronym
N/A
Scientific title
In vivo evaluation of the virucidal efficacy of Chlorhexidine and Povidone-iodine mouthwashes against salivary SARS-CoV-2
Acronym
N/A
Brief summary of the study: English
Antimicrobial mouthrinses are used in many clinical preprocedural situations for decreasing the risk of cross-contamination in the dental setting.The oral cavity is potentially high-risk transmitter of COVID-19. It is important to investigate the efficacy of mouthwash solutions against salivary SARS-CoV-2 in order to reduce the exposure of the dental team during dental procedures. This in vivo study is to evaluate the efficacy of 2 preprocedural mouthrinses in the reduction of salivary SARS-CoV-2 viral load. Saliva samples are collected from COVID-19 positive tested patients before and 5 minutes after mouthwash with 1% Povidone-iodine and 0.2% Chlorhexidine. SARS-CoV-2 rRT-PCR is then performed for each sample. Evaluation of the efficacy is based on difference in cycle threshold (Ct) value.
Brief summary of the study: Arabic
تستخدم محلولات مضادات الميكروبات كتطهير للفم قبل العلاجات السريرية في طب الاسنان. يعتبر تجويف الفم مصدر عدوى عالي الخطورة لـجائحة COVID-19. لذا هناك حاجة ماسة لإجراء تحقيق قائم على الأدلة للتأكد من فعالية محلول لغسول الفم ضد SARS-CoV-2 اللعابي لتقليل التعرض أثناء إجراءالعلاجات في عيادات طب الأسنان. تهدف هذه الدراسة إلى تقييم فعالية غسولي فم في الجسم الحي: 1٪ Povidone-iodine و 0.2٪ Chlorhexidine ضد فيروSARS-CoV-2اللعابي. يتم جمع عينات اللعاب من مصابين بجائحة COVID-19 قبل وبعد 5 دقائق من غسول الفم. ثم يتم إجراء SARS-CoV-2 rRT-PCR لكل عينة. يعتمد تقييم الفعالية على الفرق في قيمة عتبة الدورة (Ct).
Health conditions/problem studied: Specify
COVID-19/Transmission during dental treatments.
Interventions: Specify
Mouthrinse. Participants are invited to: 1- spit saliva. 2-mouthrinse with an antiseptic oral solution. 3- collect a second post-wash solution.
Key inclusion and exclusion criteria: Inclusion criteria
1- COVID-19 Positive Tested Patients in Rafic Hariri University Hospital presenting mild or moderate cases. 2- From all nationalities. 3- Participants (or guardians) give written informed consent.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
12
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
1- COVID-19 Positive Tested Patients presenting severe cases. 2- COVID-19 Positive Tested Patients presenting disabilities (Mental retardation-Physical invalidity-Psychological,troubles- Cognitive troubles affecting the capacity of discernation). 3- Participants (or guardians) who decline written informed consent.
Type of Study
Type
Interventional
Type of intervention
Preventive measures
Trial scope
Prophylaxis
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
N/A
Study design: Purpose
Prevention
Study design: Assignment
Parallel
Pharmaceutical class
Antimicrobial.
Therapeutic indication
Oral disinfection.
Therapeutic benefit
Reduce oral microbial load and risk of infection transmission.
Biospecimen retention
Samples without DNA
Biospecimen description
Saliva sample before and after mouthwash for each participant.
Target sample size
90
Actual enrollment target size
77
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
04/06/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
31/12/2020
Recruitment status
Complete
Date of completion
30/09/2020
IPD sharing statement plan
No
IPD sharing statement description
This is to be done upon request to respect the confidentially of patients.
Additional data URL
N/A
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
N/A
N/A
Sources of Monetary or Material Support
Name
Lebanese University
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Rola
El-ZEIN
Beirut
Lebanon
009613252480
roulaelzein@ul.edu.lb
Lebanese University
Scientific
Rola
El-ZEIN
Beirut
Lebanon
009613252480
roulaelzein@ul.edu.lb
Lebanese University
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Rafic Hariri University Hospita
Fouad AYOUB
Dentistry
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Other
Lebanon
01/05/2020
Fadi ABOU MRAD
cuemb@ul.edu.lb
009615463539
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
COVID-19
2-Propanol (T51.2)
Antiseptic oralmouthrinse
Interventions
Intervention
Description
Keyword
Mouthrinse
Saliva samples collected before and after mouthrinsing for each participant.
COVID-19;Dentistry;Oral antiseptic mouthwash;SARS-CoV-2
Primary Outcomes
Name
Time points
Measure
Change in cycle threshold (Ct) values of salivary SARS-CoV-2 (delta Ct) after mouthrinsing
End of study
Ct
Key Secondary Outcomes
Name
Time points
Measure
N/A
N/A
N/A
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial