CompletedNot Applicable

Evaluation of the Effect of the Gel on Sensitive Teeth

Spain31 participantsStarted 2024-07-08

Plain-language 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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in teeth sensitivity to cold air at 14 days.

Timeframe: From enrolment to the end of use at 14 days.

Change from Baseline in teeth sensitivity to periodontal probe at 14 days

Timeframe: From enrolment to the end of use at 14 days.

Trial details

NCT IDNCT07596797

SponsorLacer S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Dentine Sensitivity trials