None listed
Conditions
Brief summary
The use of antiseptics for the treatment of oropharyngeal infections have been reported in the scientific literature, and many products have the efficacy assessed by clinical studies. Conditions of the oropharynx as pharyngitis and odinofagias, and oral cavity, such as periodontal disease, mouth ulcers, stomatitis, and its symptoms, can be attenuated with the use of products containing antiseptics, antibiotics and anesthetics. The adjunctive use of these products, followed by professional treatment, is a valuable tool in the treatment of these conditions, and randomized clinical trials, double-blind, and controlled with placebo should be used to prove the effectiveness of these products. The objective of this study is to evaluate the clinical efficacy of Malvatricin 'Registered Trademark' (Lab Daudt de Oliveira, RJ) in the reducing of microorganisms associated to oropharynx infections.
Interventions
Arm 1: The solution ready-to-use contains quinosol 1 mg/ml and tyrothricin 0,1 mg/ml. It is necessary to rinse 20 ml of the solution in the mouth for 60 seconds just a single time.
Arm 2: The tablet contains quinosol 0,7 mg/tablet, tyrothricin 1,0 mg/tablet and benzocaine 5,0 mg/tablet. It is necessary to dissolve one tablet in the mouth just a single time.
Arm 3: The spray contains quinosol 2,0 mg/ml, tyrothricin 0,1 mg/ml and lidocaine chloride 4,0 mg/ml. It is necessary to perform 3 spray ap
Arm 1: The solution ready-to-use contains quinosol 1 mg/ml and tyrothricin 0,1 mg/ml. It is necessary to rinse 20 ml of the solution in the mouth for 60 seconds just a single time. Arm 2: The tablet contains quinosol 0,7 mg/tablet, tyrothricin 1,0 mg/tablet and benzocaine 5,0 mg/tablet. It is necessary to dissolve one tablet in the mouth just a single time. Arm 3: The spray contains quinosol 2,0 mg/ml, tyrothricin 0,1 mg/ml and lidocaine chloride 4,0 mg/ml. It is necessary to perform 3 spray applications in the mouth in a single time. Each pharmaceutical form was compared to its respective placebo. No strategies were used to monitor adherence to the treatment because the intervention is realized in just one visit followed by sub-investigator/investigator.
Sponsors
Laboratorio Daudt Oliveira Ltda
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Subjects presenting complaining of odinophagy from varied etiology,with up to 48 hours of evolution, recruited in private clinics of Otorhinolaryngology and invited to participate in the clinical trial after being attended and received medical assistance.
Exclusion criteria
Pregnant women and patients with malignant tumors of the oral cavity and pharynx.
Outcome results
None listed