Potassium Nitrate Gel and Diode Laser for Dentinal Hypersensitivity

Clinical Evaluation of the Combined Effect of a Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity: a Randomized Clinical Trial

The goal of this randomized clinical trial is to evaluate whether combining a potassium nitrate gel with diode laser therapy is more effective in treating dentinal hypersensitivity compared to using the gel alone. The study involves adult participants with at least two teeth affected by dentinal hypersensitivity. The main questions it aims to answer are:

Does the combined use of potassium nitrate gel and diode laser therapy reduce dentinal hypersensitivity more effectively than gel alone? How does this combined treatment impact sensitivity-related quality of life over time? Researchers will compare the outcomes between the two groups (combined therapy versus gel alone) to determine the effectiveness of the combined treatment.

Participants will:

Undergo assessments of dentinal hypersensitivity using the Shiff Air Index (SAI) and Visual Analog Scale (VAS) at baseline and at follow-ups (1 month, 3 months, and 6 months post-treatment).

Complete a questionnaire to evaluate the impact of dentinal hypersensitivity on daily life at baseline and after 6 months.

Study Overview

• Status: Completed
• Conditions: Hypersensitivity Dentin
• Intervention / Treatment: Combination product: Potassium Nitrate Gel and Diode Laser Therapy; Drug: Potassium Nitrate Gel Alone

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PV
    • Pavia, PV, Italy
      • Università degli Studi di Pavia, Department of Orthodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years or older.
• At least two teeth affected by dentinal hypersensitivity.
• Good standard of home oral hygiene.

Exclusion Criteria:

• Use of pain relievers.
• Ongoing orthodontic treatment.
• Non-vital teeth or teeth with restorative materials.
• Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Potassium Nitrate Gel with Diode Laser Therapy	Combination product: Potassium Nitrate Gel and Diode Laser Therapy; Participants in the experimental group receive treatment combining a desensitizing gel containing 5% potassium nitrate (Emoform Actisens) applied to affected teeth and diode laser therapy (980 nm). The laser is used with specific power settings (0.3W, 0.5W, 0.7W) for 20 seconds at each setting, followed by a second application of the gel and irradiation. The treatment aims to reduce dentinal hypersensitivity by occluding dentinal tubules and altering neural responses.
Active Comparator: Potassium Nitrate Gel Alone	Drug: Potassium Nitrate Gel Alone; Participants in the control group receive treatment with a desensitizing gel containing 5% potassium nitrate (Emoform Actisens) applied to the teeth. The gel is applied twice using a microbrush in a rubbing motion for 2 minutes each time. No diode laser therapy is administered. This intervention aims to evaluate the standalone efficacy of the gel in reducing dentinal hypersensitivity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Dentinal Hypersensitivity (Shiff Air Index)	The Shiff Air Index measures sensitivity by applying a standardized air stimulus to the dental surface. Patients report their sensitivity level on a scale from 0 to 3, where 0 indicates no sensitivity and 3 indicates severe sensitivity. The scores are interpreted to assess the degree of dentinal hypersensitivity.	Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4)
Reduction in Dentinal Hypersensitivity (Visual Analog Scale)	The Visual Analog Scale (VAS) measures the intensity of pain by asking participants to rate their pain on a 10-point scale, where 0 represents no pain and 10 represents the worst pain imaginable. Participants will receive guidance to mark their pain level on the scale based on their subjective experience, providing a standardized measure of dentinal hypersensitivity.	Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Quality of Life (Dentine Hypersensitivity Experience Questionnaire)	The Dentine Hypersensitivity Experience Questionnaire (DHEQ) is a validated tool designed to assess the impact of dentinal hypersensitivity on daily activities, emotions, and overall quality of life. It consists of 15 questions rated on a 1 to 7 scale, where higher scores indicate a greater negative impact on quality of life.	Baseline (T0) and 6 months (T4)

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia
• Collaborators: University of Pavia; University of Genova

Publications and helpful links

General Publications

• Simoes TM, Melo KC, Fernandes-Neto JA, Batista AL, da Silva MG, Ferreira AC, de Sousa JA, Catao MV. Use of high- and low-intensity lasers in the treatment of dentin hypersensitivity: A literature review. J Clin Exp Dent. 2021 Apr 1;13(4):e412-e417. doi: 10.4317/jced.57783. eCollection 2021 Apr.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: desensitization; potassium nitrate; Dentinal hypersensitivity; diode laser therapy; dental pain management
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 76 2022-0316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No