Ozonated Water in Treatment of Denture Stomatitis

August 27, 2023 updated by: Asmaa Nabil Elboraey, National Research Centre, Egypt

Effect of Ozone Water in Treatment of Denture Inflammation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12622
        • National Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Candida albicans colonies
Time Frame: 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.
day one, 7th day, 14th day and 30th day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
-Evaluation of inflammation and pain grade
Time Frame: day 1, and 30th day
- Evaluation of inflammation and pain grade by questionnaire
day 1, and 30th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Centre, Egypt

Investigators

  • Principal Investigator: Asmaa N, Elboraey, Ass,Pro, National Research Centre, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

August 27, 2023

First Submitted That Met QC Criteria

August 27, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4447082022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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