Dental SensitivityNCT07593755
Evaluation of Toothpaste Effect in Volunteers With Dental Sensitivity
A study testing Desensitizing toothpaste, Desensitizing toothpaste with mouthwash and Active comparator in people with Dental Sensitivity, run by Lacer S.A. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Sensitivity
- What is being tested?
- Desensitizing toothpaste, Desensitizing toothpaste with mouthwash and Active comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Odontológico Universidad de Barcelona - Bellvitge
Barcelona
About this study
Official title: 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
- Conditions
- Dental Sensitivity
- Being tested
- Desensitizing toothpaste, Desensitizing toothpaste with mouthwash, Active comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desensitizing toothpasteOther
Toothpaste was used two times a day (after meals) during 14 days
Desensitizing toothpaste with mouthwashOther
Toothpaste and mouthwash were used two times a day (after meals) during 14 days
Active comparatorOther
Toothpaste was used two times a day (after meals) during 14 days
| Study group | Role | What they receive |
|---|---|---|
| Desensitizing toothpaste | Experimental | Not described Receives: Other: Desensitizing toothpaste |
| Desensitizing toothpaste with mouthwash | Experimental | Not described Receives: Other: Desensitizing toothpaste with mouthwash |
| Regular toothpaste | Active comparator | Not described Receives: Other: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in dentine sensitivity comparing desensitizing toothpaste versus active comparator at 14 days
Measured: From enrollment to the end of use at 14 days
Secondary outcomes (2)
Change in dentine sensitivity from baseline in dentine sensitivity comparing desensitizing toothpaste group versus desensitizing toothpaste and mouthwash group at day 14.
Measured: From baseline to day 14
Change from baseline in pH at 14 days
Measured: From baseline to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Feb 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lacer S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593755
- Sponsor's protocol ID
- ES0000395/2024
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only summary of the results to support the publication will be shared. No complete study documents will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Trial to Evaluate the Efficacy of a Toothpaste in Subjects With Dental Hipersensitivity
- ClinicalTrials.gov ID
- NCT07593755
- Acronym / sponsor ID
- ES0000395/2024
- Conditions
- Dental Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Lacer S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Desensitizing toothpaste | Experimental | Other: Desensitizing toothpaste |
| Desensitizing toothpaste with mouthwash | Experimental | Other: Desensitizing toothpaste with mouthwash |
| Regular toothpaste | Active comparator | Other: Active comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desensitizing toothpasteToothpaste was used two times a day (after meals) during 14 days | Other | Desensitizing toothpaste |
| Desensitizing toothpaste with mouthwashToothpaste and mouthwash were used two times a day (after meals) during 14 days | Other | Desensitizing toothpaste with mouthwash |
| Active comparatorToothpaste was used two times a day (after meals) during 14 days | Other | Regular toothpaste |
Primary outcome
Change from Baseline in dentine sensitivity comparing desensitizing toothpaste versus active comparator at 14 days
Time frame: From enrollment to the end of use at 14 days
2 secondary outcomes
Change in dentine sensitivity from baseline in dentine sensitivity comparing desensitizing toothpaste group versus desensitizing toothpaste and mouthwash group at day 14.
Time frame: From baseline to day 14
Change from baseline in pH at 14 days
Time frame: From baseline to day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. Only summary of the results to support the publication will be shared. No complete study documents will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desensitizing toothpaste, Desensitizing toothpaste with mouthwash and Active comparator in people with Dental Sensitivity, run by Lacer S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in dentine sensitivity comparing desensitizing toothpaste versus active comparator at 14 days (time frame: From enrollment to the end of use at 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.