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

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Tooth Whitening

Intervention / Treatment
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* Device: Elgydium Clinic Sensileave Gel (V063B - DP3003)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical device group<br>Group applying the tested medical device | Device: Elgydium Clinic Sensileave Gel (V063B - DP3003)<br>* Tested product is applied/used only once a day before whitening tray wear.<br>|
| No Intervention: Control group<br>Group not applying the tested medical device | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening | The global duration (in hours) of wearing the whitening tray | About 10 days | 
| Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening | Percentage of subjects who stopped at least once trays wear because of pain | About 10 days | 
| Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening | The total number of days of not wearing trays due to pain | About 10 days | 
| Evaluate the effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on teeth whitening | Teeth colours evaluated by using VITA shades guides (Ranging from 1 to 16. Higher scores means a worse outcome). | About 10 days |