Back to resultsOzonated Water in Treatment of Denture Stomatitis
Primary Purpose
Denture Stomatitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ozonated water
Chlorhexidine mouthwash
Sponsored by
About this trial
This is an interventional treatment trial for Denture Stomatitis focused on measuring Ozonated water, denture stomatitis, Chlorhexidine mouthwash
Eligibility Criteria
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.
Sites / Locations
- National Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group I patients treated with ozonated water
Group II patients treated with chlorhexidine mouthwash
Arm Description
The patients were used ozonated water as mouth wash for treatment of denture associated oral stomatitis.
The patients were used chlorhexidine mouth wash for treatment of denture associated oral stomatitis
Outcomes
Primary Outcome Measures
Candida albicans colonies
The number of Candida albicans forming units (CFU) was used to assess the effect of two types of treatments.
Secondary Outcome Measures
-Evaluation of inflammation and pain grade
- Evaluation of inflammation and pain grade by questionnaire
Full Information
NCT ID
NCT06021847
First Posted
August 27, 2023
Last Updated
August 27, 2023
Sponsor
National Research Centre, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT06021847
Brief Title
Ozonated Water in Treatment of Denture Stomatitis
Official Title
Effect of Ozone Water in Treatment of Denture Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The effect of Ozonated water on the treatment of oral stomatitis associated with complete denture wearer in comparison to Chlorhexidine mouthwash
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Denture Stomatitis
Keywords
Ozonated water, denture stomatitis, Chlorhexidine mouthwash
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups ( complete denture wearers with oral stomatitis). Group I treated with ozonated water while group II treated with chlorhexidine mouthwash.
Masking
Participant
Masking Description
The patients didn't know which treatment they received.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I patients treated with ozonated water
Arm Type
Active Comparator
Arm Description
The patients were used ozonated water as mouth wash for treatment of denture associated oral stomatitis.
Arm Title
Group II patients treated with chlorhexidine mouthwash
Arm Type
Active Comparator
Arm Description
The patients were used chlorhexidine mouth wash for treatment of denture associated oral stomatitis
Intervention Type
Other
Intervention Name(s)
Ozonated water
Intervention Description
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.)
Intervention Type
Other
Intervention Name(s)
Chlorhexidine mouthwash
Intervention Description
Commercial available chlorhexidine mouthwash in the market was used.
Primary Outcome Measure Information:
Title
Candida albicans colonies
Description
The number of Candida albicans forming units (CFU) was used to assess the effect of two types of treatments.
Time Frame
day one, 7th day, 14th day and 30th day
Secondary Outcome Measure Information:
Title
-Evaluation of inflammation and pain grade
Description
- Evaluation of inflammation and pain grade by questionnaire
Time Frame
day 1, and 30th day
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa N, Elboraey, Ass,Pro
Organizational Affiliation
National Research Centre, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Research Centre
City
Cairo
ZIP/Postal Code
12622
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ozonated Water in Treatment of Denture Stomatitis
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