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Completed

NCT Number: NCT06021847

Ozonated Water in Treatment of Denture Stomatitis

The effect of Ozonated water on the treatment of oral stomatitis associated with complete denture wearer in comparison to Chlorhexidine mouthwash

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Key information

Conditions

Denture Stomatitis Mouth Diseases Stomatitis Stomatitis, Denture Stomatognathic Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre

Cairo, 12622, Egypt

About this study

Compete denture wearers having oral denture stomatitis were divided into two groups. group I used Ozonated water while group II used Chlorhexidine mouthwash. The growth of Candida albicans, the degree inflammation and pain grade were evaluated before starting the treatment then every week till one month. Also

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Completely edentulous male patients wearing heat cured acrylic resin removable prosthesis.
  • Patients having denture associated oral stomatitis.
  • Healthy patients free of any systemic diseases.

Exclusion criteria

  • Smoker patients.
  • Patients suffering from any auto immune or systemic diseases, Temporo-mandibular joint disorder ( TMJ disorders and parafunctional oral habits.
  • Patients with a history of radiotherapy or chemotherapy.
  • Patients having oral lesions.

Treatment and study plan

Ozonated water

Other

ozonated water was prepared with a concentration of (2-4 mg/l) ozone for 1 min. in a 25 mg of double distilled water 37o C employing an Ozone generator (Ozone generator type N 1888A, China.)

Chlorhexidine mouthwash

Other

Commercial available chlorhexidine mouthwash in the market was used.

Primary outcomes

  1. Candida albicans colonies

    Time frame: day one, 7th day, 14th day and 30th day

    The number of Candida albicans forming units (CFU) was used to assess the effect of two types of treatments.

Secondary outcomes

  1. -Evaluation of inflammation and pain grade

    Time frame: day 1, and 30th day

    • Evaluation of inflammation and pain grade by questionnaire

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Registry information

Official study title

Effect of Ozone Water in Treatment of Denture Inflammation

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2023
Registry last updated
Sep 1, 2023

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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