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

Primary Purpose

Tooth Whitening

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Elgydium Clinic Sensileave Gel (V063B - DP3003)
Sponsored by
Pierre Fabre Dermo Cosmetique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tooth Whitening

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Medical device group

    Control group

    Arm Description

    Group applying the tested medical device

    Group not applying the tested medical device

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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
    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
    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
    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).

    Full Information

    First Posted
    March 10, 2023
    Last Updated
    March 27, 2023
    Sponsor
    Pierre Fabre Dermo Cosmetique
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05804994
    Brief Title
    Evaluate the Efficacy and the Tolerance of the Medical Device V063B-DP3003 on Dentin Hypersensitivity During Teeth Whitening
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    November 15, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pierre Fabre Dermo Cosmetique

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Whitening

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    88 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Medical device group
    Arm Type
    Experimental
    Arm Description
    Group applying the tested medical device
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Group not applying the tested medical device
    Intervention Type
    Device
    Intervention Name(s)
    Elgydium Clinic Sensileave Gel (V063B - DP3003)
    Intervention Description
    Tested product is applied/used only once a day before whitening tray wear.
    Primary Outcome Measure Information:
    Title
    Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening
    Description
    NRS ranging from 0 (None) to 10 (Severe)
    Time Frame
    About 10 days
    Secondary Outcome Measure Information:
    Title
    Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening
    Description
    The global duration (in hours) of wearing the whitening tray
    Time Frame
    About 10 days
    Title
    Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening
    Description
    Percentage of subjects who stopped at least once trays wear because of pain
    Time Frame
    About 10 days
    Title
    Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening
    Description
    The total number of days of not wearing trays due to pain
    Time Frame
    About 10 days
    Title
    Evaluate the effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on teeth whitening
    Description
    Teeth colours evaluated by using VITA shades guides (Ranging from 1 to 16. Higher scores means a worse outcome).
    Time Frame
    About 10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adeline BACQUEY, Mrs
    Phone
    +33562877753
    Email
    adeline.bacquey@pierre-fabre.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christophe CHAMARD, Mr
    Phone
    +33562488566
    Email
    christophe.chamard@pierre-fabre.com

    12. IPD Sharing Statement

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

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