Assessment of the safety of a dental product
- Conditions
- Opportunistic MycosesB48.7
- Registration Number
- RBR-74hk74
- Lead Sponsor
- Ipclin - Pesquisa Clínica Integrada
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Age: 18 to 65 years. Female and male. Phototypes: I to IV. Healthy mouth except for oral affection (cold sore). Perform brushing at least 3 times a day
Active dermatoses (local and disseminated) that may interfere with the results of the study. Screening or nursing. Allergy or reactivity for the category of tested products. Participants with a history of allergy to the material used in the study. History of atopy. Immunodeficiency carriers. Renal, cardiac or hepatic transplanted. Use of the following topical systemic medicinal products: immunosuppressants, antihistamines, non-hormonal anti-inflammatories, and corticosteroids up to two weeks prior to selection. Abnormality or symptom in the region. Diabetes. Use of orthodontic appliance. Prediction of vaccination during the study or up to 03 weeks before the study. Be participating in another study. Any condition not mentioned above that, in the opinion of the investigator, could compromise the evaluation of the study. Have performed or performed oral surgeries during the study. History of lack of adherence or unwillingness to adhere to the study protocol;
Professionals directly involved in the realization of this protocol and their relatives.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To verify the absence of risk of oral mucosa irritation and discomfort sensations reported by the participants, after the use of the product in real conditions, ensuring the safety of the product to the community. The sensations of discomfort and clinical signs of each participant will be evaluated by a dermatologist and dentist, if at least 70% of the participants do not report / show feelings of discomfort or clinical signs, the product will be considered dermato and odontologically safe.
- Secondary Outcome Measures
Name Time Method In addition to safety, it will be possible to evaluate the efficacy of the product for canker sores on its end users.