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

Not Applicable

Completed

• Conditions: Tooth Whitening
• Interventions: Device: Elgydium Clinic Sensileave Gel (V063B - DP3003)

• Registration Number: NCT05804994
• Lead Sponsor: Pierre Fabre Dermo Cosmetique

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

Study Timeline

• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-07
• Study Start: 2023-04-30
• Primary Completion: 2023-12-13
• Study Completion: 2023-12-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical device group	Elgydium Clinic Sensileave Gel (V063B - DP3003)	Group applying the tested medical device

Primary Outcome Measures

Name	Time	Method
Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening	About 10 days	NRS ranging from 0 (None) to 10 (Severe)

Secondary Outcome Measures

Name	Time	Method
Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening	About 10 days	The total number of days of not wearing trays due to pain
Evaluate the effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on teeth whitening	About 10 days	Teeth colours evaluated by using VITA shades guides (Ranging from 1 to 16. Higher scores means a worse outcome).

Trial Locations

Locations (1)

Dermscan Poland; 🇵🇱 Gdańsk, Poland