Dental Sensitivity
Conditions
Brief summary
The goal of this study is to learn if a toothpaste alone and together with mouthwash 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 toothpaste help to improve signs of teeth hypersensitivity? Researchers will compare sensitive teeth toothpaste and use of sensitive teeth and mouthwash to a regular toothpaste 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 toothpaste
Toothpaste was used two times a day (after meals) during 14 days
OTHERDesensitizing toothpaste with mouthwash
Toothpaste and mouthwash were used two times a day (after meals) during 14 days
OTHERActive comparator
Toothpaste was used two times a day (after meals) during 14 days
Sponsors
Lacer S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy female and male participants (no specific gender distributions required) * Aged 18 years or older * Participants presenting dental hyperesthesia with at least two hypersensitive teeth with a verbal rating scale (VRS) score greater than or equal to 1 after tactile stimulation, and a Schiff Cold Air Sensitivity Scale score greater than or equal to 1 at the initial visit (T0). * Participants certifying the truthfulness of the personal data disclosed to the investigator. * Participants able to understand the language used at the investigation centre and comprehend the information provided by the investigator. * Participants able to follow the instructions provided by the investigator and comply with the study requirements and restrictions. * Pharmacological therapy (except for therapies listed under non-inclusion criteria) must have been stable for at least one month, with no changes expected or planned during the study * Commitment by the participants not to change the daily routine or lifestyle during the study. * Participants who have not taken part in any other similar clinical study in the previous six months. * Commitment by the participant not to use other oral hygiene products containing fluoride or ingredients such as hydroxyapatite during the study period.
Exclusion criteria
* Participants currently participating or planning to participate in other clinical trials. * Participants deprived of liberty by administrative or judicial decision or under guardianship. * Participants who cannot be contacted in the event of an emergency. * Participants admitted to a healthcare or social institution. * Participants planning hospitalization during the study period. * Participants who have taken part in a similar study without respecting an adequate washout period (defined as the use of desensitizing agents within the last six months). * Participants under pharmacological treatments that modify the evaluation of dental sensitivity or are incompatible with the requirements of the study. * Participants with a history of active caries within the past 12 months or at risk for developing caries (e.g., multiple dental restorations, crowns with compromised margins) per examiners discretion. * Participants with known allergies or sensitivities to any components of the investigational product. * Women who are breastfeeding, pregnant, or unwilling to take the adequate contraceptive measures to avoid pregnancy during the study (for women of childbearing potential). * Participants with acute, chronic, or progressive pathologies (including diabetes, cardiovascular and metabolic conditions) incompatible with the study requirements. * Any tooth surface adjacent to those surfaces under investigation that in the opinion of the investigator have any other condition that produce symptoms confounding the evaluation of cervical dentin hypersensitivity. * Participants with a medical history or taking medication, or wearing physical items (e.g., orthodontic braces) that could interfere with the study. * Participants with a history of illegal drug use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in dentine sensitivity comparing desensitizing toothpaste versus active comparator at 14 days | From enrollment to the end of use at 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Change in dentine sensitivity from baseline in dentine sensitivity comparing desensitizing toothpaste group versus desensitizing toothpaste and mouthwash group at day 14. | From baseline to day 14 |
| Change from baseline in pH at 14 days | From baseline to day 14 |
Countries
Spain
Outcome results
None listed