Ozonated Water in Treatment of Denture Stomatitis

Denture Stomatitis Clinical Trial

Official title:

Effect of Ozone Water in Treatment of Denture Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06021847
• Other study ID #: 4447082022
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Denture Stomatitis
• Stomatitis
• Stomatitis, Denture

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