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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical device group | Experimental | Group applying the tested medical device |
|
| Control group | No Intervention | Group not applying the tested medical device |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elgydium Clinic Sensileave Gel (V063B - DP3003) | Device | Tested product is applied/used only once a day before whitening tray wear. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Related to the teeth condition:
Related to the treatment/product:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermscan Poland | Gdansk | 80288 | Poland |
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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 |