Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05804994
Other study ID # V063B20220080
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 30, 2023
Est. completion date December 13, 2023

Study information

Verified date June 2024
Source Pierre Fabre Dermo Cosmetique
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Elgydium Clinic Sensileave Gel (V063B - DP3003)
Tested product is applied/used only once a day before whitening tray wear.

Locations

Country Name City State
Poland Dermscan Poland Gdansk

Sponsors (1)

Lead Sponsor Collaborator
Pierre Fabre Dermo Cosmetique

Country where clinical trial is conducted

Poland, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT00978861 - Clinical Study to Evaluate of The Whitening Efficacy and Safety of REMEWHITE Phase 3
Completed NCT03760367 - Investigation of the Instant Tooth Whitening Effect of a Silica Toothpaste Containing Blue Covarine N/A
Completed NCT03019224 - Effects of Desensitizing Dentifrices on the Reduction of Pain Sensitivity Caused by In-office Dental Whitening Phase 4