An interventional study of Potassium Nitrate Gel and Diode Laser (Active) in Dentin Hypersensitivity, sponsored by University of Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by University of Pavia · Not applicable, Interventional, and Treatment
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.
288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.
This study's enrollment of 23 is below the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →University of Pavia is the lead sponsor of 144 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Potassium Nitrate Gel · Device: Diode Laser (Active)
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).
Drug: Potassium Nitrate Gel · Device: Diode Laser (Sham)
Topical application of a 5% potassium nitrate gel (Emofrom Actisens) used to treat dentin hypersensitivity.
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.
Inactive diode laser device used for 1 minute without contact and 1 minute with contact, mimicking the active laser procedure but without energy output.
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.
Time frame: Baseline (T0), Immediately Post-Treatment (T1), 1 Month (T2), 3 Months (T3), and 6 Months (T4)
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.
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
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.
Time frame: Baseline (T0) and 6 Months Post-Treatment (T4)
Plan to share: No — Data will be available upon motivated request to the corresponding authors.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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