Recurrent aphthous stomatitis (RAS) Oral Health
Conditions
Interventions
The participants will be invited through an invitation letter and asked to contact the site when they have prodromal symptoms or when they present with ulcers. The participants referred to the study s
Sponsors
Mucocort AB
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Males or females, 12 -70 years of age 2. =2 RAS episodes over the past 6 months 3. =3 wounds at the time of the study visit 4. The diameter of the wounds <10 mm 5. The pain from RAS =4 on the NRS 6. The subjects should have the ability and willingness to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Treated at any time with mucosal topical, oral, or systemic corticosteroids less than 1 month prior to screening. 2. On TNF-alpha modulating drugs or DMARDs less than 1 month prior to screening 3. Suffering from any oral mucosal disease other than RAS at the time of enrollment 4. Any other condition as judged by the investigator to make the investigation inappropriate 5. Current alcohol or substance abuse 6. Participating in any other clinical trial or have participated in any other clinical trial within 1 month prior to the study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity measured using a numeric rating scale (NRS) at baseline and 10 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain intensity measured using a NRS at baseline and 1, 2, 4, 6, and 8 hours 2. Inadequacy of the medical device with respect to its identity, quality, durability, reliability, safety or performance will be reported as a device deficiency without unnecessary delay to the Sponsor by using the device deficiency form. It is the PI’s responsibility to record every observed device deficiency together with an assessment. The Sponsor will review all device deficiencies and determine and document in writing whether they could have led to a Serious Adverse Event (SAE). 3. Quality of life measured using EQ-5D-5L at 2 hours 4. Quality of life measured using Oral Health Impact Profile-14 (OHIP-14) scores at 2 hours | — |
Countries
Sweden
Contacts
Public ContactMats Jontell
Outcome results
None listed