Clinical trial NCT05804994: Evaluate the Efficacy and the Tolerance of the Medical Device V063B-DP3003 on Dentin Hypersensitivity During Teeth Whitening
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Whitening
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening
timeFrame: About 10 days
Secondary outcomes:
measure: Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening
timeFrame: About 10 days
measure: Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening
timeFrame: About 10 days
measure: Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening
timeFrame: About 10 days
measure: Evaluate the effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on teeth whitening
timeFrame: About 10 days
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Dermscan Poland
Study officials:
References: