Tooth Whitening Clinical Trial
Official title:
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.
Verified date | June 2024 |
Source | Pierre Fabre Dermo Cosmetique |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | December 13, 2023 |
Est. primary completion date | December 13, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Dermscan Poland | Gdansk |
Lead Sponsor | Collaborator |
---|---|
Pierre Fabre Dermo Cosmetique |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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