Efficacy of treatment of recurrent oral ulcers with ozone

Completed

• Conditions: Recurrent aphthous ulcers; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616000671460
• Lead Sponsor: Prof Mahmoud Khaled AL-Omiri

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

In order to be included in the study, participants’ age should range from 18 to 40 years old in order to avoid potential effects of age on healing of the lesions. Also, they should have no diagnosed medical disease (including previous mental or psychological disorders, auto-inflammatory disorders, hormonal conditions, haematinic deficiencies, diabetes, cardiovascular, hypertension, gastrointestinal, liver or renal disease). Participants should also have at least one intraoral labial ulcer, received no treatment for the ulcers before being included in the study and had no active periodontitis. Ulcers should be present during the clinical examination and participants should present for the purpose of this study on the first day of ulcer presence.

Exclusion Criteria

Participants with removable prosthetic rehabilitations or orthodontic appliances will be excluded from the study to avoid potential effects of the appliance on healing of the lesion. Also, participants who chew tobacco, smoked cigarettes or smoked Narghile (water pipe) will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain from ulcers, assessed using visual analogue scale (VAS) <br>[daily for 15 days post ozone/placebo treatment];Ulcer size, assessed using digital caliper (Terensa, USA)<br>[daily for 15 days post ozone/placebo treatment];Ulcer duration, assessed by counting the time (in days) required for the ulcer to disappear. It is assessed by clinical examination.[the time (in days) the ulcer requires to completely heal and disappear]

Secondary Outcome Measures

Name	Time	Method
one[None]