Artificial tooth
Conditions
Interventions
This is a clinical study to evaluate the dental safety of cosmetic products. It is expected that 35 participants, aged 18 to 65 years and phototypes from I to IV (Fitzpatrick's classification) will be
Device
Sponsors
Ipclin - Pesquisa Clínica Integrada
Labterapi Laboratório de produtos naturais EIRELI EPP
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Active dermatoses (local and disseminated) that may interfere with the study results. Pregnant or nursing mothers. Allergy or reactivity for the category of tested products. Participants with a history of allergy to the material used in the study. History of atopia.Portadores de inmunodeficiencias.Transplanted renal, cardiac or hepatic. Use of the following systemic topical medications: 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 absence of adherence or unwillingness to adhere to the study protocol. Professionals directly involved in the realization of this protocol and their relatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| In addition to safety, it will be possible to evaluate through the participants' perception the effectiveness of the product in the fixing of mobile dental prosthesis | — |
Countries
Brazil
Contacts
Public ContactCassiano Escudeiro
Ipclin - Pesquisa Clínica Integrada
Outcome results
None listed