Dermscan Poland
Gdansk, 80288, Poland
NCT Number: NCT05804994
A dental gel intended to relieve pain related to dentin hyper sensitivity is commercialized in several countries worlwide since May 2017. Its efficacy and tolerance has already been proven in dentin hyper sensitivity. In this new study, we assess the efficacy and tolerance of this tested product in a specific external agression, the teeth whitening.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Gdansk, 80288, Poland
Comparative open-label PMCF (Post-Market Clinical Follow-up) randomized controlled study will be conducted as multicentric trial in adult with dentin hypersensitivity during their teeth whitening. To evaluate the efficacy and tolerance of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity during teeth whitening
4 visits are planned:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Related to the teeth condition:
Related to the treatment/product:
Tested product is applied/used only once a day before whitening tray wear.
Time frame: About 10 days
NRS ranging from 0 (None) to 10 (Severe)
Time frame: About 10 days
The global duration (in hours) of wearing the whitening tray
Time frame: About 10 days
Percentage of subjects who stopped at least once trays wear because of pain
Time frame: About 10 days
The total number of days of not wearing trays due to pain
Time frame: About 10 days
Teeth colours evaluated by using VITA shades guides (Ranging from 1 to 16. Higher scores means a worse outcome).
Pierre Fabre Dermo Cosmetique
Industry
A Randomized, Comparative Study to Evaluate the Efficacy and Tolerance of the Medical Device Elgydium Clinic Sensileave Gel (V063B - DP3003) on Dentin Hypersensitivity During Teeth Whitening.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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