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The aim of this clinical trial is to evaluate the tolerance and efficacy of a dental gel in patients with dentinal hypersensitivity.
The aim of this clinical trial is to evaluate the tolerance and efficacy of dental gel V063B-DP3003 in patients with dentinal hypersensitivity, under normal conditions of use, under dentist control.
The primary objective of this study is to evaluate the global oral and dental tolerance of the studied product after 28 days of use.
Some efficacy objectives have been added to observe the efficacy of the dental gel. The dentinal hypersensitivity will be evaluated by the investigator with a thermal stimulus on two sensitive teeth selected by the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V063B-DP3003 | Other | all patients will received the study product (V063B-DP3003) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V063B-DP3003 | Device | The medical device V063B-DP3003 has been developed to relieve and decrease dentinal hypersensitivity in patients by creating a film around the sensitive tooth in order to prevent pain. Application modalities: apply a pea size amount of product (around 0.5g) onto each of the sensitive teeth, 3 times a day, by gentle massage with clean finger after each brushing of teeth. Do not rinse |
| Measure | Description | Time Frame |
|---|---|---|
| Global tolerance according to a 5-point grading scale taking into account physical signs observed and graded by the dentist and functionnal signs observed and graded by the patient | The global tolerance of the product is assessed by the dentist after 28 days of use, rated on a 5-point grading scale(good tolerance, very good tolerance, good tolerance, moderate tolerance) . The results of the global tolerance will take into account the physical signs observed by the dentist and the functional signs observed by the patients during the study | after 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cold air stimulus score on the schiff cold air index as a mesure of immediate efficacy | Immediate efficacy of the product at 5 and 60 minutes after application at day 1, according to Cold air Stimulus by delivered from a standard dental unit syringe and assessment of the score on the Schiff Cold air index with several measures. | 5 and 60 minutes after application at day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the product with the record of adverse event during the study | collect Adverse events during the study | during 28 days |
Inclusion Criteria:
Must have been using an effective method of contraception Negative Urine pregnancy test at inclusion,
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CHAMARD Christophe | Contact | +33 5.62.48.85.66 | christophe.chamard@pierre-fabre.com | |
| BOUYSSOUNOUSE Aurore | Contact | +33 5 62.48.85.67 | aurore.bouyssounouse.externe@pierre-fabre.com |
| Name | Affiliation | Role |
|---|---|---|
| GARNER Kelly | Intertek Life Sciences | Study Chair |
| MACLURE Robert, MD | Intertek Life Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intertek Life Sciences | Cheshire | CH66 7NZ | United Kingdom |
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| Cold air stimulus score on the schiff cold air index as a mesure of short term efficacy | Evaluate the short term efficacy of the product at Day 4 and Day 6, according to Cold air Stimulus by delivered from a standard dental unit syringe and assessment of the score on the Schiff Cold air index. | efficacy at day 4 and day 6 |
| Cold air stimulus score on the schiff cold air index as a mesure of efficacy | Evaluate the efficacy on dentinal hypersensitivity of the product between baseline and day 28, according to Cold air Stimulus by delivered from a standard dental unit syringe and assessment of the score on the Schiff Cold air index. | between baseline and day 28 |
| Tolerance with the record of functionnal signs reported by the dentist and physical signs reported by the patient. | Evaluate the oral and dental tolerance of the studied product thanks to functionnal signs reported and graded by the patient following a scale from 0=none to 4=severe and by the clinical examination of physical signs performed and graded by the investigator with a scale from 0=none to 4=severe | during 28 days |
| Acceptability of the product assessed with a questionnaire | Evaluate acceptability with a questionnaire filled out by the subject on day 28. | during 28 days |