Acrylic Resins
Conditions
Interventions
This is a phase I interventional clinical trial, open-label, non-randomized controlled, with sequential inclusion of participants. A total of 24 healthy individuals will be enrolled and allocated into
Sponsors
Universidade Federal da Paraíba
Centro de Ciências da Saúde da Universidade Federal da Paraíba
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Healthy individuals; age 18 years or older; both sexes; ability to understand and sign the Informed Consent Form; availability to use the Hawley appliance and the experimental product according to the study protocol; availability to attend clinical assessments during the study period
Exclusion criteria
Exclusion criteria: History of hypersensitivity or allergic reaction to any component of the experimental product; current use of anti-inflammatory or antimicrobial medications; use of removable dental prostheses or orthodontic appliances; use of chronic topical or systemic medications; presence of systemic diseases that may interfere with clinical evaluation; pregnancy or postpartum period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of the cleansing cream containing cinnamaldehyde at concentrations of 0.5% and 1.0% through the identification of local adverse events and clinical signs of palatal mucosal irritation such as burning sensation pain erythema edema or ulceration as well as through cytopathological analysis of the oral mucosa performed by exfoliative cytology before and after 15 days of product use | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome is expected | — |
Countries
Brazil
Contacts
Public ContactLuiz Felipe Fernandes Goncalves
Centro de Ciências da Saúde da Universidade Federal da Paraíba
Outcome results
None listed