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

Pierre Fabre

Status

Completed

Conditions

Tooth Whitening

Treatments

Device: Elgydium Clinic Sensileave Gel (V063B - DP3003)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05804994

V063B20220080

Details and patient eligibility

About

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.

Full 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

Enrollment

88 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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