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Clinical Trial Summary

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.


Clinical Trial Description

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: - 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05804994
Study type Interventional
Source Pierre Fabre Dermo Cosmetique
Contact
Status Completed
Phase N/A
Start date April 30, 2023
Completion date December 13, 2023

See also
  Status Clinical Trial Phase
Completed NCT00978861 - Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE Phase 3
Completed NCT03760367 - Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine N/A
Completed NCT03019224 - Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening Phase 4