Ozonated Water in Treatment of Denture Stomatitis

Sponsor

National Research Centre, Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT06021847

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

49.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Denture Stomatitis	Other: Ozonated water Other: Chlorhexidine mouthwash	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups ( complete denture wearers with oral stomatitis). Group I treated with ozonated water while group II treated with chlorhexidine mouthwash.Two groups ( complete denture wearers with oral stomatitis). Group I treated with ozonated water while group II treated with chlorhexidine mouthwash.

Masking:

Single (Participant)

Masking Description:

The patients didn't know which treatment they received.

Primary Purpose:

Treatment

Official Title:

Effect of Ozone Water in Treatment of Denture Inflammation

Actual Study Start Date :

May 1, 2023

Actual Primary Completion Date :

Jun 1, 2023

Actual Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group I patients treated with ozonated water The patients were used ozonated water as mouth wash for treatment of denture associated oral stomatitis.	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.)
Active Comparator: Group II patients treated with chlorhexidine mouthwash The patients were used chlorhexidine mouth wash for treatment of denture associated oral stomatitis	Other: Chlorhexidine mouthwash Commercial available chlorhexidine mouthwash in the market was used.

Arm

Intervention/Treatment

Active Comparator: Group I patients treated with ozonated water

The patients were used ozonated water as mouth wash for treatment of denture associated oral stomatitis.

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.)

Active Comparator: Group II patients treated with chlorhexidine mouthwash

The patients were used chlorhexidine mouth wash for treatment of denture associated oral stomatitis

Other: Chlorhexidine mouthwash

Commercial available chlorhexidine mouthwash in the market was used.

Outcome Measures

Primary Outcome Measures

Candida albicans colonies [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 Outcome Measures

-Evaluation of inflammation and pain grade [day 1, and 30th day]
- Evaluation of inflammation and pain grade by questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.