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

NCT05804994 | Completed

• 1 other identifier: V063B20220080
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Whitening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening

  About 10 days

• Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening

  About 10 days

• Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening

  About 10 days

• Evaluate the effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on teeth whitening

  About 10 days

Study Arms (2)

Medical device group

EXPERIMENTAL

Group applying the tested medical device

Device: Elgydium Clinic Sensileave Gel (V063B - DP3003)

Control group

NO INTERVENTION

Group not applying the tested medical device

Interventions

Elgydium Clinic Sensileave Gel (V063B - DP3003) DEVICE

Tested product is applied/used only once a day before whitening tray wear.

Medical device group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Dermscan Poland

Gdansk, 80288, Poland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 7, 2023
• Study Start: April 30, 2023
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

PL (1)