Tooth SensitivitySENS-BIOREPNCT07057141
Biomimetic Hydroxyapatite Toothpaste and Mouthwash for Reducing Dental Sensitivity
A study testing Biorepair Total Protection Toothpaste and Biorepair High-Density Mouthwash in people with Tooth Sensitivity and Gingival Recession Generalized Moderate, run by University of Pavia at 1 site in Italy.
Trial summary
This randomized controlled clinical trial evaluates the effectiveness of a biomimetic hydroxyapatite-based toothpaste and mouthwash in reducing dental sensitivity in patients with gingival recession. A total of 100 participants will be randomly assigned to two groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tooth Sensitivity, Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate
- What is being tested?
- Biorepair Total Protection Toothpaste and Biorepair High-Density Mouthwash
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2025to 15 Sep 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged between 18 and 70;
- Subjects with gingival recession and tooth sensitivity;
- Subjects who have agreed to give their free written informed consent to participate in the study.
Who cannot join
- Male and female subjects who are not adults;
- Subjects without gingival recessions;
- Subjects without dental sensitivity;
- Subjects with poor participation or insufficient motivation to participate in this study.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Effect of Biomimetic Hydroxyapatite-Based Toothpaste and Mouthwash on Dental Sensitivity in Patients With Gingival Recession: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial evaluates the effectiveness of a biomimetic hydroxyapatite-based toothpaste and mouthwash in reducing dental sensitivity in patients with gingival recession. A total of 100 participants will be randomly assigned to two groups. The control group will receive Biorepair Total Protection toothpaste, and the trial group will receive Biorepair high-density mouthwash. Both products will be applied for 30 seconds. Dental sensitivity will be assessed before and after treatment using the Shiff Air Index and the Visual Analogue Scale (VAS).
- Conditions
- Tooth Sensitivity, Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate
- Being tested
- Biorepair Total Protection Toothpaste, Biorepair High-Density Mouthwash
- Keywords
- Dental Hypersensitivity, Tooth Sensitivity, Gingival Recession, Dentin Hypersensitivity, Hydroxyapatite, Biomimetic Hydroxyapatite, Toothpaste, Mouthwash, Visual Analogue Scale (VAS), Shiff Air Index, Desensitizing Agents, Oral Health
- Medical subject headings
- Dentin Sensitivity, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biorepair Total Protection ToothpasteDevice
Application of Biorepair Total Protection toothpaste for 30 seconds, performed once in a clinical setting. The aim is to reduce dental sensitivity in patients with gingival recession.
Biorepair High-Density MouthwashDevice
Application of Biorepair High-Density mouthwash for 30 seconds, performed once in a clinical setting. The aim is to reduce dental sensitivity in patients with gingival recession.
| Study group | Role | What they receive |
|---|---|---|
| Control Group - Toothpaste | Active comparator | 50 participants will receive a single 30-second application of Biorepair Total Protection toothpaste. The intervention aims to reduce dental sensitivity in patients with gingival recession. Clinical indices (Schiff Air Index and VAS) will be assessed before and after application. Receives: Device: Biorepair Total Protection Toothpaste |
| Trial Group - Mouthwash | Experimental | 50 participants will receive a single 30-second application of Biorepair high-density mouthwash. The intervention aims to reduce dental sensitivity in patients with gingival recession. Clinical indices (Schiff Air Index and VAS) will be assessed before and after application. Receives: Device: Biorepair High-Density Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dental Sensitivity Measured by the Schiff Air Index
Variation in dental sensitivity scores assessed using the Schiff Air Index at baseline (T0) and after a 30-second application of either toothpaste or mouthwash (T1). The Schiff scale ranges from 0 (no response) to 3 (painful response to air stimulus), with higher scores indicating greater sensitivity.
Measured: T0 (baseline) and T1 (immediately post-treatment, same visit)
Secondary outcomes (1)
Change in Pain Perception Measured by the Visual Analogue Scale (VAS)
Variation in perceived pain intensity related to dental sensitivity, reported by the patient using the Visual Analogue Scale (VAS) at two timepoints: T0 (baseline) and T1 (immediately after 30-second treatment with either toothpaste or mouthwash). The VAS is a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: T0 (baseline) and T1 (immediately post-treatment, same visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start15 Jul 2025
- Primary completion5 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, Associate Professor, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057141
- Sponsor's protocol ID
- 2025-SENSBIOREPAIR
- Acronym
- SENS-BIOREP
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the corresponding authors.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biomimetic Hydroxyapatite-Based Toothpaste and Mouthwash on Dental Sensitivity in Patients With Gingival Recession: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07057141
- Acronym / sponsor ID
- SENS-BIOREP / 2025-SENSBIOREPAIR
- Conditions
- Tooth Sensitivity, Gingival Recession Generalized Moderate, Gingival Recession Localized Moderate
- Keywords
- Dental Hypersensitivity, Tooth Sensitivity, Gingival Recession, Dentin Hypersensitivity, Hydroxyapatite, Biomimetic Hydroxyapatite, Toothpaste, Mouthwash
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 9 Jul 2025 (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.
This randomized controlled clinical trial evaluates the effectiveness of a biomimetic hydroxyapatite-based toothpaste and mouthwash in reducing dental sensitivity in patients with gingival recession. A total of 100 participants will be randomly assigned to two groups. The control group will receive Biorepair Total Protection toothpaste, and the trial group will receive Biorepair high-density mouthwash. Both products will be applied for 30 seconds. Dental sensitivity will be assessed before and after treatment using the Shiff Air Index and the Visual Analogue Scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group - Toothpaste | Active comparator | Device: Biorepair Total Protection Toothpaste50 participants will receive a single 30-second application of Biorepair Total Protection toothpaste. The intervention aims to reduce dental sensitivity in patients with gingival recession. Clinical indices (Schiff Air Index and VAS) will be assessed before and after application. |
| Trial Group - Mouthwash | Experimental | Device: Biorepair High-Density Mouthwash50 participants will receive a single 30-second application of Biorepair high-density mouthwash. The intervention aims to reduce dental sensitivity in patients with gingival recession. Clinical indices (Schiff Air Index and VAS) will be assessed before and after application. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects aged between 18 and 70;
- Subjects with gingival recession and tooth sensitivity;
- Subjects who have agreed to give their free written informed consent to participate in the study.
Key exclusion criteria (4 listed)
- Male and female subjects who are not adults;
- Subjects without gingival recessions;
- Subjects without dental sensitivity;
- Subjects with poor participation or insufficient motivation to participate in this study.
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 |
|---|---|---|
| Biorepair Total Protection ToothpasteApplication of Biorepair Total Protection toothpaste for 30 seconds, performed once in a clinical setting. The aim is to reduce dental sensitivity in patients with gingival recession. | Device | Control Group - Toothpaste |
| Biorepair High-Density MouthwashApplication of Biorepair High-Density mouthwash for 30 seconds, performed once in a clinical setting. The aim is to reduce dental sensitivity in patients with gingival recession. | Device | Trial Group - Mouthwash |
Primary outcome
Change in Dental Sensitivity Measured by the Schiff Air Index
Time frame: T0 (baseline) and T1 (immediately post-treatment, same visit)
Variation in dental sensitivity scores assessed using the Schiff Air Index at baseline (T0) and after a 30-second application of either toothpaste or mouthwash (T1). The Schiff scale ranges from 0 (no response) to 3 (painful response to air stimulus), with higher scores indicating greater sensitivity.
1 secondary outcome
Change in Pain Perception Measured by the Visual Analogue Scale (VAS)
Time frame: T0 (baseline) and T1 (immediately post-treatment, same visit)
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 17 Sep 2025.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the corresponding authors.
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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.
Andrea Scribante, Associate Professor principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biorepair Total Protection Toothpaste and Biorepair High-Density Mouthwash in people with Tooth Sensitivity and Gingival Recession Generalized Moderate, run by University of Pavia at 1 site in Italy.
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 3 inclusion and 4 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 17 Sep 2025. 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 Italy. 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 in Dental Sensitivity Measured by the Schiff Air Index (time frame: T0 (baseline) and T1 (immediately post-treatment, same visit)). 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 17 Sep 2025.