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Not yet recruiting NCT06942026

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

Phase IV Interventional Oral Mucosal Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Control 1.
Who it may be relevant to
Registry conditions: Oral Mucosal Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Drug Control 1
    Researchers will perform oral care with ozonated water and hypochlorous acid solution to restore oral mucous membrane integrity.

Primary outcome measures

  • oral assessment guide [Time frame: From enrollment to the end of treatment at 1 week.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Aydın Adnan Menderes Univercity — Aydin

Publications

  • 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. PMID 34687483
  • Turk G, Ozdemir S. Comparative Effects of Chlorhexidine, Ozonated Water, and Hypochlorous Acid Solutions for Oral Care on Mucosal Integrity in Mechanically Ventilated Patients. Oral Dis. 2026 Mar 19. doi: 10.1111/odi.70245. Online ahead of print. PMID 41853915

Identifiers

NCT: NCT06942026 · 1758-1738-28-08-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗