Assessment of the safety of a dental product

Not Applicable

• Conditions: Artificial tooth; E06.780.346.875

• Registration Number: RBR-3znpr6
• Lead Sponsor: Ipclin - Pesquisa Clínica Integrada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

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

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

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.

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 through the participants' perception the effectiveness of the product in the fixing of mobile dental prosthesis