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NCT Number: NCT06746558

Potassium Nitrate Gel and Diode Laser for Dentinal Hypersensitivity

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.

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Key information

Conditions

Hypersensitivity Dentin Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università degli Studi di Pavia, Department of Orthodontics

Pavia, PV, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Potassium Nitrate Gel and Diode Laser Therapy

Combination Product

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.

Potassium Nitrate Gel Alone

Drug

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.

Primary outcomes

  1. Reduction in Dentinal Hypersensitivity (Shiff Air Index)

    Time frame: Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4)

    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.

  2. Reduction in Dentinal Hypersensitivity (Visual Analog Scale)

    Time frame: Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4).

    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.

Secondary outcomes

  1. Changes in Quality of Life (Dentine Hypersensitivity Experience Questionnaire)

    Time frame: Baseline (T0) and 6 months (T4)

    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.

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Collaborators

  • University of Genova
  • University of Pavia

Registry information

Official study title

Clinical Evaluation Of The Combined Effect Of A Potassium Nitrate Gel And Diode Laser In The Treatment Of Dentinal Hypersensitivity: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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