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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06021847
Other study ID # 4447082022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date June 1, 2023

Study information

Verified date July 2022
Source National Research Centre, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ozonated water
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
Commercial available chlorhexidine mouthwash in the market was used.

Locations

Country Name City State
Egypt National Research Centre Cairo

Sponsors (1)

Lead Sponsor Collaborator
National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Candida albicans colonies The number of Candida albicans forming units (CFU) was used to assess the effect of two types of treatments. day one, 7th day, 14th day and 30th day
Secondary -Evaluation of inflammation and pain grade - Evaluation of inflammation and pain grade by questionnaire day 1, and 30th day
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