Effects of Chlorhexidine Gluconate, Ozonated Water and Hypochlorous Acid Solutions Used in the Oral Care of Patients Supported by Mechanical Ventilation on the Integrity of the Oral Mucosa

April 16, 2025 updated by: Sercan Özdemir, Aydin Adnan Menderes University

The purpose of this clinical trial is to learn whether ozonated water and hypochlorous acid solution can restore the integrity of the oral mucosa. In addition, the investigators will learn about the safety of ozonated water and hypochlorous acid solution. The main questions that participants need to answer are:

What medical conditions do participants have while taking ozonated water and hypochlorous acid solution?

Investigators will compare ozonated water and hypochlorous acid solution with 0.12% chlorhexidine gluconate solution to see if it helps to restore the integrity of the oral mucosa.

Participants:

Participants will be asked to agree to receive oral care 4 times a day, every day for 1 week.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

63

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
      • Aydın, Turkey
        • Aydın Adnan Menderes Univercity

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be between the ages of 18-65,
  • Have been on mechanical ventilation for at least 24 hours,
  • Have no intolerance or allergy to the solutions,
  • Agree to participate in the study

Exclusion Criteria:

  • Having a contraindication for oral care
  • Not agreeing to participate in the study

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental 1
Ozonated water
Drug: Control 1
Researchers will perform oral care with ozonated water and hypochlorous acid solution to restore oral mucous membrane integrity.
Other Names:
  • %0.12 chlorhexidine gluconate
Experimental: Experimental 2
hypochlorous acid
Drug: Control 1
Researchers will perform oral care with ozonated water and hypochlorous acid solution to restore oral mucous membrane integrity.
Other Names:
  • %0.12 chlorhexidine gluconate
Active Comparator: Control 1
%0.12 chlorhexidine gluconate
Drug: Control 1
Researchers will perform oral care with ozonated water and hypochlorous acid solution to restore oral mucous membrane integrity.
Other Names:
  • %0.12 chlorhexidine gluconate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oral assessment guide
Time Frame: From enrollment to the end of treatment at 1 week.
The Oral Assessment Scale will be used to assess patients' oral mucosa before oral care is provided. his scale has sections on the lips, mucosa, tongue, teeth and saliva. Each section is scored from1 to 4, and the total score is between 5 and 20. A score of 5 is assessed as normal oral mucosa, 6-10 as slight dysfunction, 11-15 as moderate dysfunction and 16-20 as severe dysfunction.
From enrollment to the end of treatment at 1 week.

Collaborators and Investigators

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

Sponsor

Aydin Adnan Menderes 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

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 (Estimated)

April 27, 2025

Primary Completion (Estimated)

May 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1758-1738-28-08-2024

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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