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Trial registered on ANZCTR


Registration number
ACTRN12616000671460
Ethics application status
Approved
Date submitted
16/04/2016
Date registered
23/05/2016
Date last updated
23/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of treatment of recurrent oral ulcers with ozone
Scientific title
Ozone treatment of recurrent aphthous stomatitis: a double blinded study
Secondary ID [1] 289023 0
None
Universal Trial Number (UTN)
U1111-1177-5801
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent aphthous ulcers 298439 0
Condition category
Condition code
Oral and Gastrointestinal 298535 298535 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294507 0
Treatment: Other
Comparator / control treatment
A control group of RAS patients who matched the participants in group one with age and gender will also be recruited. Participants in control group will receive air for 60 seconds 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.
Control group
Placebo

Outcomes
Primary outcome [1] 298026 0
Pain from ulcers, assessed using visual analogue scale (VAS)
Timepoint [1] 298026 0
daily for 15 days post ozone/placebo treatment
Primary outcome [2] 298221 0
Ulcer size, assessed using digital caliper (Terensa, USA)
Timepoint [2] 298221 0
daily for 15 days post ozone/placebo treatment
Primary outcome [3] 298222 0
Ulcer duration, assessed by counting the time (in days) required for the ulcer to disappear. It is assessed by clinical examination.
Timepoint [3] 298222 0
the time (in days) the ulcer requires to completely heal and disappear
Secondary outcome [1] 322959 0
None
Timepoint [1] 322959 0
None

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/01/2016
Date of last participant enrolment
Anticipated
Actual
10/01/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
138
Recruitment outside Australia
Country [1] 7823 0
Jordan
State/province [1] 7823 0
Amman

Funding & Sponsors
Funding source category [1] 293388 0
Self funded/Unfunded
Name [1] 293388 0
Unfunded
Country [1] 293388 0
Primary sponsor type
Individual
Name
Prof Mahmoud Khaled AL-Omiri
Address
Prof Mahmoud AL-Omiri,
Faculty of Dentistry,
University of Jordan,
Queen's Noor Street,
Amman 11942,
Jordan
Country
Jordan
Secondary sponsor category [1] 292208 0
None
Name [1] 292208 0
Address [1] 292208 0
Country [1] 292208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294845 0
Academic Research Committee, Faculty of Dentistry, University of Jordan
Ethics committee address [1] 294845 0
Academic Research Committee,
Faculty of Dentistry,
University of Jordan,
Queen's Noor Street,
Amman 11942,
Jordan
Ethics committee country [1] 294845 0
Jordan
Date submitted for ethics approval [1] 294845 0
02/01/2015
Approval date [1] 294845 0
20/01/2015
Ethics approval number [1] 294845 0
15/2015

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65218 0
Prof Mahmoud Khaled AL-Omiri
Address 65218 0
Prof Mahmoud AL-Omiri,
Faculty of Dentistry,
University of Jordan,
Queen's Noor Street,
Amman 11942
Jordan
Country 65218 0
Jordan
Phone 65218 0
+962795571629
Fax 65218 0
Email 65218 0
[email protected]
Contact person for public queries
Name 65219 0
Mahmoud Khaled AL-Omiri
Address 65219 0
Prof Mahmoud AL-Omiri,
Faculty of Dentistry,
University of Jordan,
Queen's Noor Street,
Amman 11942
Jordan
Country 65219 0
Jordan
Phone 65219 0
+962795571629
Fax 65219 0
Email 65219 0
[email protected]
Contact person for scientific queries
Name 65220 0
Mahmoud Khaled AL-Omiri
Address 65220 0
Prof Mahmoud AL-Omiri,
Faculty of Dentistry,
University of Jordan,
Queen's Noor Street,
Amman 11942
Jordan
Country 65220 0
Jordan
Phone 65220 0
+962795571629
Fax 65220 0
Email 65220 0
[email protected]

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