Dental Prosthesis, Healthy Volunteers
Conditions
Interventions
This is a single-center, single-blind, non-comparative, single-arm clinical study lasting 28 days. The study will involve 33 participants of both genders who wear removable dentures. All participants
Sponsors
Kley Hertz Farmacêutica S.A
Medcin Instituto da Pele Ltda
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers; both genders; aged between 18 and 70 years; users of removable dental prostheses; who have used or currently use adhesive creams; agreement to follow the study procedures and attend the center on specified dates and times for evaluations; understanding, consenting, and signing the informed consent form
Exclusion criteria
Exclusion criteria: Pregnancy or risk of pregnancy, breastfeeding; use of anti-inflammatory, immunosuppressive, antihistamine drugs up to 3 weeks prior to selection; atopic history or allergies to health products in this category; active pathologies and or skin lesions (localized and or widespread) in the evaluation area; immunosuppression due to drugs or active diseases; decompensated endocrinopathies; relevant clinical history or current evidence of alcohol or drug abuse; known history or suspected intolerance to products in the same category; Intense sun exposure up to 15 days prior to the evaluation; aesthetic or dermatological treatments up to 4 weeks prior to the evaluation; other conditions considered by the investigator as reasonable for disqualification from study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To verify, under real-use conditions, the absence of irritation risk and capture discomfort sensations in the studied population, based on dental evaluation criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the perceived effectiveness of the product from the target audience's perspective, under real-use conditions | — |
Countries
Brazil
Contacts
Public ContactSérgio Schalka
Medcin Instituto da Pele Ltda
Outcome results
None listed