Ozonated Water in Treatment of Denture Stomatitis

NCT06021847 | Completed DMC

• 1 other identifier: 4447082022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Denture Stomatitis

Keywords

Ozonated water; denture stomatitis; Chlorhexidine mouthwash

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• -Evaluation of inflammation and pain grade

  day 1, and 30th day

Study Arms (2)

Group I patients treated with ozonated water

ACTIVE COMPARATOR

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

Other: Ozonated water

Group II patients treated with chlorhexidine mouthwash

ACTIVE COMPARATOR

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

Other: Chlorhexidine mouthwash

Interventions

Ozonated water 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 I patients treated with ozonated water

Chlorhexidine mouthwash OTHER

Commercial available chlorhexidine mouthwash in the market was used.

Group II patients treated with chlorhexidine mouthwash

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Completely edentulous male patients wearing heat cured acrylic resin removable prosthesis.
• Patients having denture associated oral stomatitis.
• Healthy patients free of any systemic diseases.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Research Centre

Cairo, 12622, Egypt

Location

MeSH Terms

Conditions

Stomatitis, Denture

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Asmaa N, Elboraey, Ass,Pro

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients didn't know which treatment they received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Removable Prosthodontics

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

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: May 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 1, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)