Alternative Application Methods of Pre-procedural Povidone Iodine Mouthrinse

April 20, 2024 updated by: Wannakorn Sriarj, Chulalongkorn University
To compare the iodine remaining in saliva between gargle method and swab method

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Faculty of Dentistry, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Iodine gargle 0.2 %
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
Iodine gargle 0.2 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0, 5, 10, 20, 30, 60 and 120 minutes
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)
0, 5, 10, 20, 30, 60 and 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Wannakorn Sriar, Faculty of Dentistry, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

April 20, 2024

Study Completion (Actual)

April 20, 2024

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 20, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HREC-DCU 2023-074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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