Dentin HypersensitivityKN-LASERNCT06967818
Combined Use of Potassium Nitrate Gel and Diode Laser for Dentin Hypersensitivity
A study testing Potassium Nitrate Gel and Diode Laser (Active) in people with Dentin Hypersensitivity, run by University of Pavia at 1 site in Italy.
Trial summary
The aim of this clinical trial is to evaluate the efficacy of the combined use of a diode laser and a potassium nitrate-based desensitizing gel in reducing dentin hypersensitivity in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Potassium Nitrate Gel and Diode Laser (Active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2025to 10 Jan 2026
- 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
- Patients with good oral hygiene
- Presence of at least one tooth affected by dentin hypersensitivity
- Signed informed consent
Who cannot join
- Use of analgesic medication
- Ongoing orthodontic treatment
- Non-vital (endodontically treated) teeth
- Teeth with restorative materials on the surface
- Pregnant or breastfeeding women
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: Clinical Evaluation of the Combined Effect of a Potassium Nitrate-Based Gel and Diode Laser in the Treatment of Dentin Hypersensitivity: A Randomized Controlled Trial
The aim of this clinical trial is to evaluate the efficacy of the combined use of a diode laser and a potassium nitrate-based desensitizing gel in reducing dentin hypersensitivity in adult patients. Patients who meet the eligibility criteria and for whom informed consent has been obtained will be enrolled and assessed at five timepoints. At baseline (T0), all patients will undergo a professional dental cleaning, collection of medical and dental history, a full periodontal and dental charting, and completion of the Dentine Hypersensitivity Experience Questionnaire (DHEQ) to assess the impact of hypersensitivity on quality of life. Sensitivity will be measured using the Schiff Air Index and the Visual Analog Scale (VAS) in response to air stimulation. At T1, patients will receive the assigned treatment based on randomization. In the test group, the hypersensitive teeth will be treated with topical application of a potassium nitrate gel (Emoform Actisens, 5%) followed by irradiation with a 980 nm diode laser (1.5 W/cm² for 1 minute without contact, then 1 minute with contact and sweeping motion). In the control group, the same potassium nitrate gel will be applied, but the laser will remain inactive (sham laser). Immediately after treatment, the Schiff Air Index and VAS will be reassessed. Follow-up evaluations will be conducted at T2 (1 month after treatment), T3 (3 months), and T4 (6 months). At each follow-up visit, sensitivity will again be measured using the Schiff and VAS indices. At the final follow-up (T4), the DHEQ questionnaire will be administered a second time to assess changes in the patients' perceived impact of dentin hypersensitivity on daily life. Patients are randomized into two groups: Test group: potassium nitrate gel plus active diode laser (980 nm); Control group: potassium nitrate gel plus sham diode laser (inactive). The study aims to determine whether the addition of diode laser irradiation enhances the desensitizing effect of the potassium nitrate gel in both the short and long term (from T1 to T4), as measured by changes in Schiff Air Index, VAS scores, and DHEQ results.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Potassium Nitrate Gel, Diode Laser (Active), Diode Laser (Sham)
- Keywords
- Dentin Hypersensitivity, Potassium Nitrate, Diode Laser, Dental Pain, Desensitizing Treatment, Visual Analog Scale, Schiff Air Index, Laser Therapy, Tooth Sensitivity, Noninvasive Dentistry
- Medical subject headings
- Dentin Sensitivity, Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium Nitrate GelDrug
Topical application of a 5% potassium nitrate gel (Emofrom Actisens) used to treat dentin hypersensitivity.
Diode Laser (Active)Device
Application of a 980 nm diode laser at 1.5 W/cm² for 1 minute without contact and 1 minute with contact, using a sweeping motion perpendicular to the long axis of the tooth.
Diode Laser (Sham)Device
Inactive diode laser device used for 1 minute without contact and 1 minute with contact, mimicking the active laser procedure but without energy output.
| Study group | Role | What they receive |
|---|---|---|
| Potassium Nitrate Gel + Active Diode Laser | Experimental | Participants receive topical application of a 5% potassium nitrate gel (Emofrom Actisens), followed by treatment with an active 980 nm diode laser (1.5 W/cm² for 1 minute without contact and 1 minute with contact, using a sweeping motion perpendicular to the long axis of the tooth).
Sensitivity is measured at baseline (T0), immediately after treatment (T1), and at 1 month (T2), 3 months (T3), and 6 months (T4). Receives: Drug: Potassium Nitrate Gel; Device: Diode Laser (Active) |
| Potassium Nitrate Gel + Sham Diode Laser | Sham comparator | Participants receive the same topical application of 5% potassium nitrate gel (Emofrom Actisens), followed by treatment with an inactive (sham) 980 nm diode laser using the same procedure and duration as in the active group, but without laser energy.
Sensitivity is measured at the same timepoints: baseline (T0), immediately after treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4). Receives: Drug: Potassium Nitrate Gel; Device: Diode Laser (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dentin Sensitivity Measured by Schiff Air Index
The Schiff Air Index is used to assess sensitivity to evaporative stimuli (air blast). Scores range from 0 to 3, with higher scores indicating greater sensitivity. Measurements will be performed at baseline, immediately after treatment, and during follow-up visits at 1, 3, and 6 months. The primary endpoint is the change in Schiff score from baseline to 6 months.
Measured: Baseline (T0), Immediately Post-Treatment (T1), 1 Month (T2), 3 Months (T3), and 6 Months (T4)
Secondary outcomes (2)
Change in Pain Perception Measured by Visual Analog Scale (VAS)
The VAS is a 10 cm horizontal line on which participants indicate their perceived pain during air stimulus, ranging from 0 (no pain) to 10 (worst imaginable pain). The secondary outcome is the reduction in VAS score between baseline and follow-up visits.
Measured: Baseline (T0), Immediately Post-Treatment (T1), 1 Month (T2), 3 Months (T3), and 6 Months (T4)
Change in Quality of Life Related to Dentin Hypersensitivity Measured by DHEQ Questionnaire
The Dentine Hypersensitivity Experience Questionnaire (DHEQ) assesses the impact of hypersensitivity on patients' daily lives. It includes 15 items scored from 1 to 7, with a total score range of 15 to 105. Higher scores indicate greater perceived impact. The outcome is the change in total score from baseline to 6 months.
Measured: Baseline (T0) and 6 Months Post-Treatment (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start15 Jul 2025
- Primary completion10 Dec 2025
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin HypersensitivityStudies 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
- 23 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
- NCT06967818
- Sponsor's protocol ID
- 2025-KNO3LASER
- Acronym
- KN-LASER
- Status last verified
- Aug 2025
- First submitted
- 4 May 2025
- Last updated
- 13 Jan 2026
- 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Combined Effect of a Potassium Nitrate-Based Gel and Diode Laser in the Treatment of Dentin Hypersensitivity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06967818
- Acronym / sponsor ID
- KN-LASER / 2025-KNO3LASER
- Conditions
- Dentin Hypersensitivity
- Keywords
- Dentin Hypersensitivity, Potassium Nitrate, Diode Laser, Dental Pain, Desensitizing Treatment, Visual Analog Scale, Schiff Air Index, Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 13 May 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.
The aim of this clinical trial is to evaluate the efficacy of the combined use of a diode laser and a potassium nitrate-based desensitizing gel in reducing dentin hypersensitivity in adult patients. Patients who meet the eligibility criteria and for whom informed consent has been obtained will be enrolled and assessed at five timepoints. At baseline (T0), all patients will undergo a professional dental cleaning, collection of medical and dental history, a full periodontal and dental charting, and completion of the Dentine Hypersensitivity Experience Questionnaire (DHEQ) to assess the impact of hypersensitivity on quality of life. Sensitivity will be measured using the Schiff Air Index and the Visual Analog Scale (VAS) in response to air stimulation. At T1, patients will receive the assigned treatment based on randomization. In the test group, the hypersensitive teeth will be treated with topical application of a potassium nitrate gel (Emoform Actisens, 5%) followed by irradiation with a 980 nm diode laser (1.5 W/cm² for 1 minute without contact, then 1 minute with contact and sweeping motion). In the control group, the same potassium nitrate gel will be applied, but the laser will remain inactive (sham laser). Immediately after treatment, the Schiff Air Index and VAS will be reassessed. Follow-up evaluations will be conducted at T2 (1 month after treatment), T3 (3 months), and T4 (6 months). At each follow-up visit, sensitivity will again be measured using the Schiff and VAS indices. At the final follow-up (T4), the DHEQ questionnaire will be administered a second time to assess changes in the patients' perceived impact of dentin hypersensitivity on daily life. Patients are randomized into two groups: Test group: potassium nitrate gel plus active diode laser (980 nm); Control group: potassium nitrate gel plus sham diode laser (inactive). The study aims to determine whether the addition of diode laser irradiation enhances the desensitizing effect of the potassium nitrate gel in both the short and long term (from T1 to T4), as measured by changes in Schiff Air Index, VAS scores, and DHEQ results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium Nitrate Gel + Active Diode Laser | Experimental | Drug: Potassium Nitrate Gel, Device: Diode Laser (Active)Participants receive topical application of a 5% potassium nitrate gel (Emofrom Actisens), followed by treatment with an active 980 nm diode laser (1.5 W/cm² for 1 minute without contact and 1 minute with contact, using a sweeping motion perpendicular to the long axis of the tooth). Sensitivity is measured at baseline (T0), immediately after treatment (T1), and at 1 month (T2), 3 months (T3), and 6 months (T4). |
| Potassium Nitrate Gel + Sham Diode Laser | Sham comparator | Drug: Potassium Nitrate Gel, Device: Diode Laser (Sham)Participants receive the same topical application of 5% potassium nitrate gel (Emofrom Actisens), followed by treatment with an inactive (sham) 980 nm diode laser using the same procedure and duration as in the active group, but without laser energy. Sensitivity is measured at the same timepoints: baseline (T0), immediately after treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with good oral hygiene
- Presence of at least one tooth affected by dentin hypersensitivity
- Signed informed consent
Key exclusion criteria (5 listed)
- Use of analgesic medication
- Ongoing orthodontic treatment
- Non-vital (endodontically treated) teeth
- Teeth with restorative materials on the surface
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Potassium Nitrate GelTopical application of a 5% potassium nitrate gel (Emofrom Actisens) used to treat dentin hypersensitivity. | Drug | Potassium Nitrate Gel + Active Diode Laser, Potassium Nitrate Gel + Sham Diode Laser |
| Diode Laser (Active)Application of a 980 nm diode laser at 1.5 W/cm² for 1 minute without contact and 1 minute with contact, using a sweeping motion perpendicular to the long axis of the tooth. | Device | Potassium Nitrate Gel + Active Diode Laser |
| Diode Laser (Sham)Inactive diode laser device used for 1 minute without contact and 1 minute with contact, mimicking the active laser procedure but without energy output. | Device | Potassium Nitrate Gel + Sham Diode Laser |
Primary outcome
Change in Dentin Sensitivity Measured by Schiff Air Index
Time frame: Baseline (T0), Immediately Post-Treatment (T1), 1 Month (T2), 3 Months (T3), and 6 Months (T4)
The Schiff Air Index is used to assess sensitivity to evaporative stimuli (air blast). Scores range from 0 to 3, with higher scores indicating greater sensitivity. Measurements will be performed at baseline, immediately after treatment, and during follow-up visits at 1, 3, and 6 months. The primary endpoint is the change in Schiff score from baseline to 6 months.
2 secondary outcomes
Change in Pain Perception Measured by Visual Analog Scale (VAS)
Time frame: Baseline (T0), Immediately Post-Treatment (T1), 1 Month (T2), 3 Months (T3), and 6 Months (T4)
Change in Quality of Life Related to Dentin Hypersensitivity Measured by DHEQ Questionnaire
Time frame: Baseline (T0) and 6 Months Post-Treatment (T4)
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 13 Jan 2026.
- 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 Potassium Nitrate Gel and Diode Laser (Active) in people with Dentin Hypersensitivity, 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 5 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 13 Jan 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 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. Some participants in this study may receive a placebo. 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 Dentin Sensitivity Measured by Schiff Air Index (time frame: Baseline (T0), Immediately Post-Treatment (T1), 1 Month (T2), 3 Months (T3), and 6 Months (T4)). 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 13 Jan 2026.