Evaluation of the Effect of the Gel on Sensitive Teeth

Evaluation of the Efficacy of a Product for Oral Care in Use Test Under Dentist Control.

The goal of this study is to learn if a tooth gel works to alleviate teeth hypersensitivity in adults. It will also learn about the safety of the product.

The main question it aims to answer is:

• Does the tooth gel help to improve signs of teeth hypersensitivity?

Researchers will compare before and after product use to see if it works to improve teeth sensitivity. Participants will:

• Use assigned products daily for 14 days
• Visit the clinic on the established days during 14 days for check-ups and evaluation

Inclusion Criteria:

• Healthy female and male subjects (no specific repartition)
• Aged between 18 years old
• Subjects with dentine hyperesthesia
• Have a minimum of two hypersensitive teeth anterior to non-consecutive molars, with cervical erosion/abrasion or gingival recession, and with a grade greater than or equal to 1 on the verbal rating scale (VRS) after tactile simulation, and greater than or equal to 1 on the Schiff cold air sensitive scale at the beginning of the study.
• Subjects certifying the truthfulness of the personal data disclosed to the investigator
• Subjects able to understand the language used in the investigation canter and the information given by the investigator
• Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
• The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
• Commitment not to change the daily routine or the lifestyle
• Subjects who have not been recently involved in any other similar study
• Commitment not to use during the study period other products with the same effect of the tested product
• Subjects informed about the test procedures and who have signed a consent form.

Exclusion Criteria:

• Subjects participating or planning to participate in other clinical trials;
• Subjects deprived of liberty by administrative or judicial decision or under guardianship;
• Subjects who cannot be contacted in an emergency;
• Subjects admitted to a health or social center;
• Subjects planning hospitalization during the study;
• Subjects who participated in a similar study without respecting an adequate washout period (used any desensitizing agents during the last three months);
• Subjects who have used anti sensitivity products in the 4 weeks prior to screening;
• Subjects under pharmacological treatments that the investigator considers incompatible with the requirements of the study;
• Subjects who have had active caries within 12 months or who are at risk of caries development (multiple dental restorations, crowns with compromised margin) per examiners discretion;
• Subjects who have shown allergies or sensitivity to any component of the product;
• Subject breastfeeding, pregnant or not willing to take the necessary precautions to avoid pregnancy during the study (for women of childbearing age).
• Any tooth surface adjacent to those surfaces under investigation, which in the opinion of the investigator have any other condition that provides symptoms confusing with those of cervical dentin hypersensitivity.