Stomatitis Aphthous
Conditions
Interventions
This is a single-blind, non-comparative, single-group clinical study, with approximately 35 participants of either sex, aged between 18 and 70 years, healthy individuals who self-report having a predi
Sponsors
ALS Beauty & Personal Care Ltda
ALS Beauty & Personal Care Ltda
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Healthy research participants; agreement to adhere to the study procedures and requirements and to attend the institute on the days and times determined for the evaluations; ability to consent to their participation in the study; age from 18 to 70 years; any sex; vaccinated against covid 19; who self declare as having a predisposition to sensitive oral mucosa and with the occurrence of mouth ulcers or oral wounds caused by factors such as stress, acidic foods, burns, ingestion of hot foods, use of orthodontic appliances, stomatitis, use of medications or herpes; who self declare as having sensations of dry mouth
Exclusion criteria
Exclusion criteria: Participants who smoke; are pregnant or breastfeeding; have changes outside the normal range assessed by the dentist in the oral cavity that may compromise the results of the study or that may put the participant's health at risk; are undergoing any medical treatment that, in the opinion of the investigator, may compromise the results of the study or put the participant's health at risk; have skin conditions in the area where the product is applied; have removable partial or total dentures, provided that more than 50% of the teeth are missing; have type 1 diabetes mellitus; are insulin-dependent diabetes; have complications resulting from diabetes, such as retinopathies, nephropathy, neuropathy; have dermatoses related to diabetes, such as plantar ulcers, lipoid necrobiosis, granuloma annulare, and opportunistic infections; have a history of episodes of hypoglycemia, diabetic ketoacidosis, and/or hyperosmolar coma; are undergoing immunosuppression; are currently using topical or systemic corticosteroids, immunosuppressants, and antihistamines; have a history of reactions to the category of the product being tested; other diseases or medications that may directly interfere with the study or put the health of the research participant at risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Verify the acceptability of the oral cavity after use of the investigational product by observing the non occurrence of adverse events and sensations of discomfort when used under recommended conditions of use. | — |
Secondary
| Measure | Time frame |
|---|---|
| Verify effectiveness through the subjective perception of the research participant through self assessments of effectiveness under recommended conditions of use | — |
Countries
Brazil
Contacts
Public ContactGabrielli Brianezi
ALS Beauty & Personal Care Ltda
Outcome results
None listed