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

NCT06967818 | Completed

• 1 other identifier: 2025-KNO3LASER
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Keywords

Dentin Hypersensitivity; Potassium Nitrate; Diode Laser; Dental Pain; Desensitizing Treatment; Visual Analog Scale; Schiff Air Index; Laser Therapy; Tooth Sensitivity; Noninvasive Dentistry

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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

  Baseline (T0) and 6 Months Post-Treatment (T4)

Study Arms (2)

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).

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).

Drug: Potassium Nitrate Gel; Device: Diode Laser (Sham)

Interventions

Potassium Nitrate Gel DRUG

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

Potassium Nitrate Gel + Active Diode Laser; Potassium Nitrate Gel + Sham Diode Laser

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.

Potassium Nitrate Gel + Active Diode Laser

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.

Potassium Nitrate Gel + Sham Diode Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Dentin Sensitivity; Toothache

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Andrea Scribante, Associate Professor

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 13, 2025
• Study Start: July 15, 2025
• Primary Completion: December 10, 2025
• Study Completion: January 10, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)