Evaluate the Efficacy and the Tolerance of the Medical Device V063B-DP3003 on Dentin Hypersensitivity During Teeth Whitening

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05804994
• Other study ID #: V063B20220080
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Tooth Whitening

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