The Retention of Iodine in Saliva Over the TimeNCT06272019

Alternative Application Methods of Pre-procedural Povidone Iodine Mouthrinse

A study testing Iodine gargle in people with The Retention of Iodine in Saliva Over the Time and The Comparison of Iodine in Saliva Between Gargle and Swab, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare the iodine remaining in saliva between gargle method and swab method Read more about this study

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: The Retention of Iodine in Saliva Over the Time, The Comparison of Iodine in Saliva Between Gargle and Swab
What is being tested?: Iodine gargle
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteThailand
Study dates: 1 Sep 2023to 20 Apr 2024
Phase: Interventional
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 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Thai people
no underlying disease, no pregnant
at least 24 teeth
No use iodine gargle
No allergy to iodine and seafood
No orthodontic and prosthetic treatment

Show all 9Show fewer

No ulcer and edentulous area
Saliva flow rate in male (0.57+-0.3 ml/minute), in woman (0.41+-0.27 ml/minute)
PI score lower than 0.6 (Green and vermillion index)

Who cannot join

treatment orthodontic or prosthetic treatment currently
Allergy to iodine between reach
Can not participate

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Faculty of Dentistry, Chulalongkorn University
Bangkok

Other trials in Thailand

About this study

To compare the iodine remaining in saliva between gargle method and swab method

Read the detailed description

separate the participant in 2 groups group 1 use iodine gargle with gargle method, after 48 hours use iodine gargle with swab method group 2 use iodine gargle with swab method, after 48 hours use iodine gargle with gargle method The researcher will collect saliva before use iodine gargle and after use at time 0, 5, 10, 20, 30, 60, 120 minutes

Conditions: The Retention of Iodine in Saliva Over the Time, The Comparison of Iodine in Saliva Between Gargle and Swab
Being tested: Iodine gargle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Iodine gargleOther
Iodine gargle 0.2 %

Study groups in NCT06272019
Study group	Role	What they receive
Gargle method	Experimental	the participant will use 0.2% iodine gargle with gargle method by hold in mouth 30 second and gargle 30 seconds after that spit out Receives: Other: Iodine gargle
Swab method	Experimental	the participant will use 0.2 iodine gargle with swab method by the researcher apply on mouth 1 minute without spit out Receives: Other: Iodine gargle

What is being measured

The primary outcome is the main question the study is designed to answer.

The rate of retention of iodine in saliva
The retention of iodine in saliva after get the gargle (show in percentage)
Measured: 0, 5, 10, 20, 30, 60 and 120 minutes
The comparison of the retention of iodine between gargle and swab
The comparison of rate of retention of iodine in saliva between gargle and swab (show in percentage)
Measured: 0, 5, 10, 20, 30, 60 and 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202320 Apr 2024

First posted22 Feb 2024
Study start1 Sep 2023
Primary completion20 Apr 2024
Study completion20 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for The Retention of Iodine in Saliva Over the TimeStudies of the same condition, open and under way.
More trials run by Chulalongkorn 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Model description: the participant will use iodine gargle in 2 method
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06272019
Sponsor's protocol ID: HREC-DCU 2023-074
Status last verified: Apr 2024
First submitted: 14 Feb 2024
Last updated: 23 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Tabatabaeizadeh SA. Airborne transmission of COVID-19 and the role of face mask to prevent it: a systematic review and meta-analysis. Eur J Med Res. 2021 Jan 2;26(1):1. doi: 10.1186/s40001-020-00475-6.
PubMed 33388089
Hu B, Guo H, Zhou P, Shi ZL. Characteristics of SARS-CoV-2 and COVID-19. Nat Rev Microbiol. 2021 Mar;19(3):141-154. doi: 10.1038/s41579-020-00459-7. Epub 2020 Oct 6.
PubMed 33024307
Zou X, Chen K, Zou J, Han P, Hao J, Han Z. Single-cell RNA-seq data analysis on the receptor ACE2 expression reveals the potential risk of different human organs vulnerable to 2019-nCoV infection. Front Med. 2020 Apr;14(2):185-192. doi: 10.1007/s11684-020-0754-0. Epub 2020 Mar 12.
PubMed 32170560
Chen L, Zhao J, Peng J, Li X, Deng X, Geng Z, Shen Z, Guo F, Zhang Q, Jin Y, Wang L, Wang S. Detection of SARS-CoV-2 in saliva and characterization of oral symptoms in COVID-19 patients. Cell Prolif. 2020 Dec;53(12):e12923. doi: 10.1111/cpr.12923. Epub 2020 Oct 19.
PubMed 33073910
Xu H, Zhong L, Deng J, Peng J, Dan H, Zeng X, Li T, Chen Q. High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa. Int J Oral Sci. 2020 Feb 24;12(1):8. doi: 10.1038/s41368-020-0074-x.
PubMed 32094336
Okui T, Matsuda Y, Karino M, Hideshima K, Kanno T. Oral Mucosa Could Be an Infectious Target of SARS-CoV-2. Healthcare (Basel). 2021 Aug 19;9(8):1068. doi: 10.3390/healthcare9081068.
PubMed 34442205
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 32047895
Lippi G, Mattiuzzi C, Bovo C, Plebani M. Current laboratory diagnostics of coronavirus disease 2019 (COVID-19). Acta Biomed. 2020 May 11;91(2):137-145. doi: 10.23750/abm.v91i2.9548.
PubMed 32420937
Ge 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 32425001
Jamal M, Shah M, Almarzooqi SH, Aber H, Khawaja S, El Abed R, Alkhatib Z, Samaranayake LP. Overview of transnational recommendations for COVID-19 transmission control in dental care settings. Oral Dis. 2021 Apr;27 Suppl 3(Suppl 3):655-664. doi: 10.1111/odi.13431. Epub 2020 Jun 3.
PubMed 32428372
Peng 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 32127517
Cochran MA, Miller CH, Sheldrake MA. The efficacy of the rubber dam as a barrier to the spread of microorganisms during dental treatment. J Am Dent Assoc. 1989 Jul;119(1):141-4. doi: 10.14219/jada.archive.1989.0131.
PubMed 2760346
Samaranayake LP, Reid J, Evans D. The efficacy of rubber dam isolation in reducing atmospheric bacterial contamination. ASDC J Dent Child. 1989 Nov-Dec;56(6):442-4.
PubMed 2681303
Samaranayake LP, Peiris M. Severe acute respiratory syndrome and dentistry: a retrospective view. J Am Dent Assoc. 2004 Sep;135(9):1292-302. doi: 10.14219/jada.archive.2004.0405.
PubMed 15493394
Kariwa H, Fujii N, Takashima I. Inactivation of SARS coronavirus by means of povidone-iodine, physical conditions and chemical reagents. Dermatology. 2006;212 Suppl 1(Suppl 1):119-23. doi: 10.1159/000089211.
PubMed 16490989

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alternative Application Methods of Pre-procedural Povidone Iodine Mouthrinse
ClinicalTrials.gov ID: NCT06272019
Acronym / sponsor ID: HREC-DCU 2023-074
Conditions: The Retention of Iodine in Saliva Over the Time, The Comparison of Iodine in Saliva Between Gargle and Swab
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Chulalongkorn UniversityUniversity, hospital or other
Study start: 1 Sep 2023 (actual)
Primary completion: 20 Apr 2024 (actual)
Study completion: 20 Apr 2024 (actual)
First posted: 22 Feb 2024 (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.

To compare the iodine remaining in saliva between gargle method and swab method

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: the participant will use iodine gargle in 2 method

Arm	Type	Receives
Gargle method	Experimental	Other: Iodine garglethe participant will use 0.2% iodine gargle with gargle method by hold in mouth 30 second and gargle 30 seconds after that spit out
Swab method	Experimental	Other: Iodine garglethe participant will use 0.2 iodine gargle with swab method by the researcher apply on mouth 1 minute without spit out

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Thai people
no underlying disease, no pregnant
at least 24 teeth
No use iodine gargle
No allergy to iodine and seafood

Key exclusion criteria (3 listed)

treatment orthodontic or prosthetic treatment currently
Allergy to iodine between reach
Can not participate

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
Iodine gargleIodine gargle 0.2 %	Other	Gargle method, Swab method

Primary outcome

The rate of retention of iodine in saliva
Time frame: 0, 5, 10, 20, 30, 60 and 120 minutes
The retention of iodine in saliva after get the gargle (show in percentage)
The comparison of the retention of iodine between gargle and swab
Time frame: 0, 5, 10, 20, 30, 60 and 120 minutes
The comparison of rate of retention of iodine in saliva between gargle and swab (show in percentage)

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 23 Apr 2024.
Background: PubMed 33388089Tabatabaeizadeh SA. Airborne transmission of COVID-19 and the role of face mask to prevent it: a systematic review and meta-analysis. Eur J Med Res. 2021 Jan 2;26(1):1. doi: 10.1186/s40001-020-00475-6.
Background: PubMed 33024307Hu B, Guo H, Zhou P, Shi ZL. Characteristics of SARS-CoV-2 and COVID-19. Nat Rev Microbiol. 2021 Mar;19(3):141-154. doi: 10.1038/s41579-020-00459-7. Epub 2020 Oct 6.
Background: PubMed 32170560Zou X, Chen K, Zou J, Han P, Hao J, Han Z. Single-cell RNA-seq data analysis on the receptor ACE2 expression reveals the potential risk of different human organs vulnerable to 2019-nCoV infection. Front Med. 2020 Apr;14(2):185-192. doi: 10.1007/s11684-020-0754-0. Epub 2020 Mar 12.
Background: PubMed 33073910Chen L, Zhao J, Peng J, Li X, Deng X, Geng Z, Shen Z, Guo F, Zhang Q, Jin Y, Wang L, Wang S. Detection of SARS-CoV-2 in saliva and characterization of oral symptoms in COVID-19 patients. Cell Prolif. 2020 Dec;53(12):e12923. doi: 10.1111/cpr.12923. Epub 2020 Oct 19.
Background: PubMed 32094336Xu H, Zhong L, Deng J, Peng J, Dan H, Zeng X, Li T, Chen Q. High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa. Int J Oral Sci. 2020 Feb 24;12(1):8. doi: 10.1038/s41368-020-0074-x.
Background: PubMed 34442205Okui T, Matsuda Y, Karino M, Hideshima K, Kanno T. Oral Mucosa Could Be an Infectious Target of SARS-CoV-2. Healthcare (Basel). 2021 Aug 19;9(8):1068. doi: 10.3390/healthcare9081068.
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.
Background: PubMed 32420937Lippi G, Mattiuzzi C, Bovo C, Plebani M. Current laboratory diagnostics of coronavirus disease 2019 (COVID-19). Acta Biomed. 2020 May 11;91(2):137-145. doi: 10.23750/abm.v91i2.9548.
Background: 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.
Background: PubMed 32428372Jamal M, Shah M, Almarzooqi SH, Aber H, Khawaja S, El Abed R, Alkhatib Z, Samaranayake LP. Overview of transnational recommendations for COVID-19 transmission control in dental care settings. Oral Dis. 2021 Apr;27 Suppl 3(Suppl 3):655-664. doi: 10.1111/odi.13431. Epub 2020 Jun 3.
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 2760346Cochran MA, Miller CH, Sheldrake MA. The efficacy of the rubber dam as a barrier to the spread of microorganisms during dental treatment. J Am Dent Assoc. 1989 Jul;119(1):141-4. doi: 10.14219/jada.archive.1989.0131.
interim guidance for minimizing risk of COVID-19transmissionLink provided by the sponsor.
Thai dental guidelineLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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.

Wannakorn Sriar principal investigator

Faculty of Dentistry, Chulalongkorn University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 3 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 23 Apr 2024. 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 Thailand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

The rate of retention of iodine in saliva (time frame: 0, 5, 10, 20, 30, 60 and 120 minutes). 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 NCT06272019, which also lists 22 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 23 Apr 2024.