Ozonated Water in Treatment of Denture Stomatitis

NCT ID: NCT06021847

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-06-01

Brief Summary

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

Detailed Description

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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

Conditions

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Denture Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Participants
The patients didn't know which treatment they received.

Study Groups

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Group I patients treated with ozonated water

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

Group Type ACTIVE_COMPARATOR

Ozonated water

Intervention Type 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.)

Group II patients treated with chlorhexidine mouthwash

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type OTHER

Commercial available chlorhexidine mouthwash in the market was used.

Interventions

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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.)

Intervention Type OTHER

Chlorhexidine mouthwash

Commercial available chlorhexidine mouthwash in the market was used.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Nabil Elboraey

Associate Professor of Removable Prosthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asmaa N, Elboraey, Ass,Pro

Role: PRINCIPAL_INVESTIGATOR

National Research Centre, Egypt

Locations

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National Research Centre

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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4447082022

Identifier Type: -

Identifier Source: org_study_id

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