Combined Use of Potassium Nitrate Gel and Diode Laser for Dentin Hypersensitivity

NCT ID: NCT06967818

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2026-01-10

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Potassium Nitrate Gel + Active Diode Laser

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).

Group Type: EXPERIMENTAL

Potassium Nitrate Gel

Intervention Type: DRUG

Topical application of a 5% potassium nitrate gel (Emofrom Actisens) used to treat dentin hypersensitivity.

Diode Laser (Active)

Intervention Type: 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.

Potassium Nitrate Gel + Sham Diode Laser

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).

Group Type: SHAM_COMPARATOR

Potassium Nitrate Gel

Intervention Type: DRUG

Topical application of a 5% potassium nitrate gel (Emofrom Actisens) used to treat dentin hypersensitivity.

Diode Laser (Sham)

Intervention Type: 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.

Interventions

Potassium Nitrate Gel

Topical application of a 5% potassium nitrate gel (Emofrom Actisens) used to treat dentin hypersensitivity.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with good oral hygiene
• Presence of at least one tooth affected by dentin hypersensitivity
• Signed informed consent

Exclusion Criteria

• Use of analgesic medication
• Ongoing orthodontic treatment
• Non-vital (endodontically treated) teeth
• Teeth with restorative materials on the surface
• Pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, Italy

Countries

Italy

Other Identifiers

2025-KNO3LASER

Identifier Type: -

Identifier Source: org_study_id