CClinicalTrials.gg
CompletedNCT06272019Updated Apr 23, 2024

Alternative Application Methods of Pre-procedural Povidone Iodine Mouthrinse

An interventional study of Iodine gargle in The Retention of Iodine in Saliva Over the Time and The Comparison of Iodine in Saliva Between Gargle and Swab, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2023, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • The Retention of Iodine in Saliva Over the Time
  • The Comparison of Iodine in Saliva Between Gargle and Swab
03

In context

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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
  • 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)

Exclusion criteria

Exclusion Criteria:

  • treatment orthodontic or prosthetic treatment currently
  • Allergy to iodine between reach
  • Can not participate
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Gargle method

    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

    Other: Iodine gargle

  • Experimental
    Swab method

    the participant will use 0.2 iodine gargle with swab method by the researcher apply on mouth 1 minute without spit out

    Other: Iodine gargle

Interventions

  • OtherIodine gargle

    Iodine gargle 0.2 %

06

What researchers measure

Primary outcomes

  1. The rate of retention of iodine in saliva

    The retention of iodine in saliva after get the gargle (show in percentage)

    Time frame: 0, 5, 10, 20, 30, 60 and 120 minutes

  2. 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)

    Time frame: 0, 5, 10, 20, 30, 60 and 120 minutes

07

Study locations

1 site
  • Faculty of Dentistry, Chulalongkorn University
    Bangkok, Thailand
08

References and documents

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. Erratum In: Nat Rev Microbiol. 2022 May;20(5):315. doi: 10.1038/s41579-022-00711-2. 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 ↗
  • Eggers M, Koburger-Janssen T, Eickmann M, Zorn J. In Vitro Bactericidal and Virucidal Efficacy of Povidone-Iodine Gargle/Mouthwash Against Respiratory and Oral Tract Pathogens. Infect Dis Ther. 2018 Jun;7(2):249-259. doi: 10.1007/s40121-018-0200-7. Epub 2018 Apr 9. PubMed 29633177 ↗
  • Ather A, Patel B, Ruparel NB, Diogenes A, Hargreaves KM. Coronavirus Disease 19 (COVID-19): Implications for Clinical Dental Care. J Endod. 2020 May;46(5):584-595. doi: 10.1016/j.joen.2020.03.008. Epub 2020 Apr 6. PubMed 32273156 ↗
  • Bidra AS, Pelletier JS, Westover JB, Frank S, Brown SM, Tessema B. Comparison of In Vitro Inactivation of SARS CoV-2 with Hydrogen Peroxide and Povidone-Iodine Oral Antiseptic Rinses. J Prosthodont. 2020 Aug;29(7):599-603. doi: 10.1111/jopr.13220. Epub 2020 Jul 24. PubMed 32608097 ↗
  • Martinez Lamas L, Diz Dios P, Perez Rodriguez MT, Del Campo Perez V, Cabrera Alvargonzalez JJ, Lopez Dominguez AM, Fernandez Feijoo J, Diniz Freitas M, Limeres Posse J. Is povidone iodine mouthwash effective against SARS-CoV-2? First in vivo tests. Oral Dis. 2022 Apr;28 Suppl 1(Suppl 1):908-911. doi: 10.1111/odi.13526. Epub 2020 Jul 29. No abstract available. PubMed 32615642 ↗
  • Reis INR, do Amaral GCLS, Mendoza AAH, das Gracas YT, Mendes-Correa MC, Romito GA, Pannuti CM. Can preprocedural mouthrinses reduce SARS-CoV-2 load in dental aerosols? Med Hypotheses. 2021 Jan;146:110436. doi: 10.1016/j.mehy.2020.110436. Epub 2020 Nov 27. PubMed 33288313 ↗
  • Rattanawiboon C, Chaweewannakorn C, Saisakphong T, Kasevayuth K, Trairatvorakul C. Effective Fluoride Mouthwash Delivery Methods as an Alternative to Rinsing. Nurs Res. 2016 Jan-Feb;65(1):68-75. doi: 10.1097/NNR.0000000000000131. PubMed 26657482 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06272019
Lead sponsor
Chulalongkorn University
Responsible party
Wannakorn Sriarj (Assistant professor, Chulalongkorn University) — Principal investigator
First posted
Feb 22, 2024
Start date
Sep 1, 2023
Primary completion
Apr 20, 2024
Completion
Apr 20, 2024
Last update
Apr 23, 2024

Study contacts

Wannakorn Sriar
principal investigator · Faculty of Dentistry, Chulalongkorn University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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