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

NCT ID: NCT06942026

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-27

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Mucosal Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental 1

Ozonated water

Group Type EXPERIMENTAL

Control 1

Intervention Type DRUG

Researchers will perform oral care with ozonated water and hypochlorous acid solution to restore oral mucous membrane integrity.

Experimental 2

hypochlorous acid

Group Type EXPERIMENTAL

Control 1

Intervention Type DRUG

Researchers will perform oral care with ozonated water and hypochlorous acid solution to restore oral mucous membrane integrity.

Control 1

%0.12 chlorhexidine gluconate

Group Type ACTIVE_COMPARATOR

Control 1

Intervention Type DRUG

Researchers will perform oral care with ozonated water and hypochlorous acid solution to restore oral mucous membrane integrity.

Interventions

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Control 1

Researchers will perform oral care with ozonated water and hypochlorous acid solution to restore oral mucous membrane integrity.

Intervention Type DRUG

Other Intervention Names

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%0.12 chlorhexidine gluconate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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Sercan Özdemir

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aydın Adnan Menderes Univercity

Aydin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Sercan Özdemir

Role: CONTACT

+90 256 220 29 00

References

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Ozdemir S, Turk G. The effect of different concentrations of chlorhexidine on microbial colonization: A double-blinded randomized controlled study. Int J Nurs Pract. 2022 Apr;28(2):e13025. doi: 10.1111/ijn.13025. Epub 2021 Oct 23.

Reference Type BACKGROUND
PMID: 34687483 (View on PubMed)

Other Identifiers

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1758-1738-28-08-2024

Identifier Type: -

Identifier Source: org_study_id

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