Tooth Whitening
Conditions
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
Interventions
DEVICEElgydium Clinic Sensileave Gel (V063B - DP3003)
Tested product is applied/used only once a day before whitening tray wear.
Sponsors
Pierre Fabre Dermo Cosmetique
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 global duration (in hours) of wearing the whitening tray |
| 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). |
Countries
Poland
Outcome results
None listed