Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT05804994
Eligibility Criteria:
Inclusion Criteria:
* Subject who has a pain score (i.e. maximum intensity felt while the whitening tray wear) of at least 3 on a NRS ranging from 0 (None) to 10 (Severe) evaluated since the beginning of his teeth whitening.
* Subject wishing to have a teeth whitening
* Subject with a healthy gum status according to the investigator
* Subject with at least 20 natural teeth
Exclusion Criteria:
Related to the teeth condition:
* Subject with active teeth decay
* Subject with teeth showing evidence of facets of attrition, premature contact, cracked enamel on the teeth to be studied and adjacent teeth
* Subject with teeth showing evidence of irreversible pulpitis and active periodontal disease
* Subject having a cutaneous-mucosal disease liable to interfere with study data according to the investigator
* Subject with an odontological condition, an acute chronic or progressive disease or history of disease considered by the investigator hazardous for the subject or incompatible with the study
Related to the treatment/product:
* Subject having undergone professional desensitizing therapy in the mouth
* Systemic treatment/product and topical treatment/product in the mouth liable to interfere with study data according to the investigator assessment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05804994
Study Brief:
Protocol Section:
NCT05804994