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NCT Number: 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

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.

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Key information

Conditions

Oral Mucosal Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aydın Adnan Menderes Univercity

Aydin, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control 1

Drug

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

Other names: %0.12 chlorhexidine gluconate

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sercan Özdemir

CONTACT

[email protected]

+90 256 220 29 00

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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