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Completed

NCT Number: NCT05804994

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermscan Poland

Gdansk, 80288, Poland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elgydium Clinic Sensileave Gel (V063B - DP3003)

Device

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

Primary outcomes

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

    Time frame: About 10 days

    NRS ranging from 0 (None) to 10 (Severe)

Secondary outcomes

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

    Time frame: About 10 days

    The global duration (in hours) of wearing the whitening tray

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

    Time frame: About 10 days

    Percentage of subjects who stopped at least once trays wear because of pain

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

    Time frame: About 10 days

    The total number of days of not wearing trays due to pain

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

    Time frame: About 10 days

    Teeth colours evaluated by using VITA shades guides (Ranging from 1 to 16. Higher scores means a worse outcome).

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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