Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in People With Epidermolysis Bullosa.
Epidermolysis Bullosa, Oral Ulcer
About this trial
This is an interventional supportive care trial for Epidermolysis Bullosa focused on measuring Epidermolysis Bullosa, Oral ulcer, Oral blisters, Dentoxol mouthrinse
Eligibility Criteria
Inclusion Criteria:
- People living with Inherited Epidermolysis Bullosa, including all types and subtypes, registered at Debra Foundation at the country of the study.
Exclusion Criteria:
- Unable to give written informed consent / assent.
- Have used a mouth rinse aimed at managing oral ulcers in the last 4 weeks.
- Known allergy/intolerance to any component of the study rinse.
- Planning to use any of the following contraindicated medications during the study period (pain medications are allowed)
- Any agent marketed for oral mucositis
- Steroids
- Antibiotics (eg, tetracyclines) (Note: topical antifungals are allowed)
- Povidone iodine
- Sucralfate and other coating agents such as Gelclair, MuGard, etc.
- Caphosol
- Chlorhexidine Gluconate (Oralgene, Perioaid, Peridex, Periogard)
- Diphenhydramine (Benadryl)
- Laser therapy for oral mucositis
- Any other anti-inflammatory agent
- Any other investigative agent
- *Note: "Miracle / Magic" rinse preparations containing viscous lidocaine are allowed, however, diphenhydramine and other excluded agents should not be added.
- Age below 6 years
- Pregnant or nursing
- Unable to rinse the mouth due to limited oral functioning.
Sites / Locations
- Facultad de Odontología, Universidad de Chile
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Group A
Group A, second period
Group B
Group B, second period
First 6 weeks they will use the mouthrinse 5 times a day, following 4 week washout period.
After the washout period, the next 6 weeks the will use the mouthrinse twice a day. On week 0, 1, 3 and 6 of each regime patients living in the metropolitan area will be examined by the Oral Medicine specialist.
First 6 weeks they will use the mouthrinse twice a day, following 4 week washout period
After the washout period, the next 6 weeks they will use the mouthrinse 5 times a day. On week 0, 1, 3 and 6 of each regime patients living in the metropolitan area will be examined by the Oral Medicine specialist.