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

Sponsor

Pierre Fabre Dermo Cosmetique (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05804994

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tooth Whitening	Device: Elgydium Clinic Sensileave Gel (V063B - DP3003)	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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.

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Nov 15, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Medical device group Group applying the tested medical device	Device: Elgydium Clinic Sensileave Gel (V063B - DP3003) Tested product is applied/used only once a day before whitening tray wear.
No Intervention: Control group Group not applying the tested medical device

Arm

Intervention/Treatment

Experimental: Medical device group

Group applying the tested medical device

Device: Elgydium Clinic Sensileave Gel (V063B - DP3003)

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

No Intervention: Control group

Group not applying the tested medical device

Outcome Measures

Primary Outcome Measures

Evaluate the soothing effect of the medical device Elgydium Clinic Sensileave Gel (V063B - DP3003) on dentin hypersensitivity due to teeth whitening [About 10 days]
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 [About 10 days]
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 [About 10 days]
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 [About 10 days]
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 [About 10 days]
Teeth colours evaluated by using VITA shades guides (Ranging from 1 to 16. Higher scores means a worse outcome).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pierre Fabre Dermo Cosmetique

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pierre Fabre Dermo Cosmetique

ClinicalTrials.gov Identifier:

NCT05804994

Other Study ID Numbers:

V063B20220080

First Posted:

Apr 7, 2023

Last Update Posted:

Apr 7, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dentin Sensitivity

Hypersensitivity

Study Results

No Results Posted as of Apr 7, 2023