NCT05804994

Evaluate the Efficacy and the Tolerance of the Medical Device V063B-DP3003 on Dentin Hypersensitivity During Teeth Whitening

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Tooth Whitening

Interventions

Type	Name	Description
DEVICE	Elgydium Clinic Sensileave Gel (V063B - DP3003)	Tested product is applied/used only once a day before whitening tray wear.

Timeline

• Start date: 2023-04-30
• Primary completion: 2023-12-13
• Completion: 2023-12-13
• First posted: 2023-04-07
• Last updated: 2024-06-18

Locations

1 site across 1 country: Poland