None listed
Conditions
Brief summary
Background: Ozone (O3) is a triatomic molecule, the third most potent oxidant after fluorine and per sulfate, and unstable gas that cannot be stored and should be used at once because it has a half-life of 40 min at 20 Celsius degrees (1,2). Ozone gas works as antimicrobial agent against bacteria, viruses, fungi, and protozoa. It also has the capacity to stimulate blood circulation and the immune response. Such features justify the current interest in its application in medicine and dentistry and have been indicated for the treatment of 260 different pathologies in medicine and dentistry (1-6). Previous studies on role of ozone in treatment of oral ulcers are in scarse and this provoked the conduction of this study to shed more light on the role of ozone in management of oral ulcers. Aims and objectives: The aim of this study was to assess the therapeutic effects of 60 seconds of ozone application on ulcer size, ulcer duration and pain caused by recurrent aphthous ulcers. The study hypothesis for this study was that ozone application for 60 seconds has a role in treatment of RAS lesions and has effects on ulcer size, ulcer duration or pain caused by RAS lesions. References: 1. Burns DT. Early problems in the analysis and the determination of ozone. Fresenius J Anal Chem. 1997;357:178–83. 2. Bocci VA. Scientific and Medical Aspects of Ozone Therapy: State of the Art. Arch Med Res. 2006;37:425–35. 3. Nogales CG, Ferrari PH, Kantorovich EO, Lage-Marques JL. Ozone therapy in medicine and dentistry. J Contemp Dent Pract. 2008;9:75–84. 4. Saini R. Ozone therapy in dentistry: A strategic review. J Nat Sci Biol Med. 2011;2:151-153 5. Baysan A, Whiley RA, Lynch E. Antimicrobial effect of a novel ozonegenerating device on micro-organisms associated with primary root carious lesions in vitro. Caries Res 2000;34:498-501. 6. Fernandez E et al. Low concentration H2O2/TiO_N in office bleaching - a randomized clinical trial. J DENT RES 2014.
Interventions
Participants with Recurrent Aphthous Stomatitis (RAS) will be recruited into study group 1. A control group of RAS patients who matched the participants in group one with age and gender will also be recruited. The first consecutive 60-70 participants will be allocated to intervention group (group 1), and the final consecutive 60-70 participants will be allocated to control group. One labial mucosa RAS lesion in each participant from group 1 will be exposed to ozone gas for 60 seconds while parti
Participants with Recurrent Aphthous Stomatitis (RAS) will be recruited into study group 1. A control group of RAS patients who matched the participants in group one with age and gender will also be recruited. The first consecutive 60-70 participants will be allocated to intervention group (group 1), and the final consecutive 60-70 participants will be allocated to control group. One labial mucosa RAS lesion in each participant from group 1 will be exposed to ozone gas for 60 seconds while participants in the control group will receive air for 60 seconds (no treatment). The labial mucosa ulcer in each participant in group 1 will be exposed to 2350 ppm of ozone gas with a flow rate of 615 cc per minute for 60 seconds using the healOzone X4 machine (healOzone X4, Curozone, Germany) which requires an adequate seal of its delivery system to be able to work and provide ozone. Ozone will be applied on the lesion through special disposable silicone cups that permit adequate seal and avoid gas escape which ensures the safety of the machine for human use. A registered dentist will perform the explained procedures for this intervention. The used healOzone machine is specially designed by having a switch at the back of the device which can be switched to deliver only air and no ozone for the controls. Participants in control group will receive the same treatment but with air instead of ozone and no subject will be informed if they were in the test or the control group. Ulcer size and pain will be recorded for each participant at baseline and daily for 15 days. Ulcers duration will be determined by recording the time they require to disappear.
Sponsors
Prof Mahmoud Khaled AL-Omiri
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Outcome results
None listed