patients with recurrent aphthous stomatitis MedDRA version: 6.1 Level: PT Classification code 10028084
Conditions
Interventions
Trade Name: FERTOMCIDINA U*SOLUZ FL 100ML
Pharmaceutical Form: Mouth wash
CAS Number: 69-72-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
CAS Number: 7681-8
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with clinical diagnosis of recurrent aphthous stomatitis (RAS) minor. 2.Clinical history of RAS from at least 2 years, with at least 3 episodes per year. 3.Patients with superior or equal age to 18 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patients, with RAS history, that have performed topical or systemic therapy in 30 preceding days the beginning of the study. 2.Treatment with sistemic antibiotics prior to 2 weeks of study entry. 3.Treatment with systemic steroid or other immunomodulatory agents within 1 month of study entry. 4.Dental surgery within 2 weeks of study entry. 5.Patients affected from chronic serious pathology 6.Patients with diagnosis of Behcet's syndrome. 7.Liquidated hypersensitivity or suspects to the medicines in experimentation or to medicines chemically correlated. 8.Patients with haematinic deficiencies, in particular vitamin B12, folate and iron. 9.Presence of orthodontic appliances. 10.Smokers patients. 11.Patients contingent upon alcohol and/or drugs. 12.Patients not in degree to perform correctly the topical like that therapy as expected from the protocol 13.Patients not able to undergo to the periodical check control proposed by the study. 14.Pregnant women or in presumed pregnancy. 15.Attendances in any other clinical trial during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - verifying if the Fertomcidina ?U? to use topical as mouth rinse, applied on the oral lesions twice a day for 7 days, is able to improve symptoms and objective signs, in comparison with the chlorhexidine 0 , 2 % mouthwash; - verifying if the incidence of side effects is different in the two groups of treatment; - verifying the stability of the therapeutic result in a period of 8 weeks, after the suspension of the treatment with the two topical drugs;;Secondary Objective: - verifying the rapidity of action of the different drugs, - cost;Primary end point(s): To consider as clinically remarkable a difference, even unitary, among the value of the parameter of gotten effectiveness from the group treated with Fertomcidina ''u'', in comparison with the group treated with chlorhexidine 0,2 %, concerning the remission of the symptoms and the reduction of the gravity of the objective signs. To consider the stability of the therapeutic result in the 8 weeks following the suspension of the treatments, and moreover, any possible differences among the 2 groups of research. | — |
Countries
Italy
Outcome results
None listed