Evaluate the Efficacy and the Tolerance of the Medical Device V063B-DP3003 on Dentin Hypersensitivity During Teeth Whitening
NCT ID: NCT05804994
Last Updated: 2024-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2023-04-30
2023-12-13
Brief Summary
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Detailed Description
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4 visits are planned:
* Visit 1 (V1) - Selection
* Visit 2 (V2) - Start of teeth whitening
* Visit 3 (V3) - Start of tested product application - Inclusion / Randomization
* Visit 4 (V4) - Study end
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Medical device group
Group applying the tested medical device
Elgydium Clinic Sensileave Gel (V063B - DP3003)
Tested product is applied/used only once a day before whitening tray wear.
Control group
Group not applying the tested medical device
No interventions assigned to this group
Interventions
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Elgydium Clinic Sensileave Gel (V063B - DP3003)
Tested product is applied/used only once a day before whitening tray wear.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Pierre Fabre Dermo Cosmetique
INDUSTRY
Responsible Party
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Locations
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Dermscan Poland
Gdansk, , Poland
Countries
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Other Identifiers
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V063B20220080
Identifier Type: -
Identifier Source: org_study_id
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