Dentine Sensitivity
Conditions
Brief summary
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
Interventions
OTHERDesensitizing tooth gel
Desensitizing tooth gel was used 3 times a day after meals during 14 days
Sponsors
Lacer S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in teeth sensitivity to cold air at 14 days. | From enrolment to the end of use at 14 days. | Change evaluated by VAS score scale from 0 to 3, where 0 means the absence of pain while 3 is the highest pain. |
| Change from Baseline in teeth sensitivity to periodontal probe at 14 days | From enrolment to the end of use at 14 days. | Change evaluated by VAS score scale: from 0 to 10, where 0 means the absence of pain while 10 is the highest pain |
Countries
Spain
Outcome results
None listed