Evaluation of the safety and efficacy of using the mint-flavored denture fixative cream product through Acceptability Assessment in the oral cavity

• Conditions: Edentulous arcade; E06.780.346

• Registration Number: RBR-897tzz6
• Lead Sponsor: Kosmoscience Ciência e Tecnologia Cosmética Limitada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-29
• Study Completion: 2022-09-26
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Age range between 18 and 60 years. Female and male. Phototype (Fitzpatrick): I to VI. Being a user of removable dental prostheses (dentures). Be a user of products of the same category. Agree on procedures and requirements during study use: study time (after 21 days) laboratory to perform investigational product home study procedures, change the product study diary, do not change the study product study diary. Agree to perform facial aesthetic dermatological treatments until the end of the study (21 days), such as: peelings, laser, fillers, use of any unusual suitable products

Exclusion Criteria

Pregnant or lactating women. Participant who belongs to the risk group for COVID-19, that is, with cardiovascular, renal and chronic respiratory problems, immunosuppressed or other conditions that the doctor judges as belonging to the risk group. Presence of dermatoses, active skin lesions (local and/or disseminated) or irritation in the mouth region (internal or external). Expected vaccination during the study or up to 3 weeks before the study. History of oral pathologies. Use of non-steroidal anti-inflammatory drugs, corticosteroids, antihistamines, photosensitizers or immunosuppressants up to 2 weeks before the study. Be participating in another study in the same application region. History of non-adherence or unwillingness to adhere to the study protocol. Being undergoing dental treatment. Not taking vitamin A or derivatives. Any condition that, in the opinion of the researcher, could compromise the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified