Evaluation of Toothpaste Effect in Volunteers With Dental Sensitivity

Comparative Clinical Trial to Evaluate the Efficacy of a Toothpaste in Subjects With Dental Hipersensitivity

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

Study Overview

• Status: Completed
• Conditions: Dental Sensitivity
• Intervention / Treatment: Other: Desensitizing toothpaste; Other: Desensitizing toothpaste with mouthwash; Other: Active comparator

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Odontológico Universidad de Barcelona - Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regular toothpaste	Other: Active comparator; Toothpaste was used two times a day (after meals) during 14 days
Experimental: Desensitizing toothpaste	Other: Desensitizing toothpaste; Toothpaste was used two times a day (after meals) during 14 days
Experimental: Desensitizing toothpaste with mouthwash	Other: Desensitizing toothpaste with mouthwash; Toothpaste and mouthwash were used two times a day (after meals) during 14 days

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Lacer S.A.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemical Actions and Uses; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Specialty Uses of Chemicals; Cosmetics; Mouthwashes
• Other Study ID Numbers: ES0000395/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only summary of the results to support the publication will be shared. No complete study documents will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No