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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06746558
Enrollment
12
Registered
2024-12-24
Start date
2023-01-07
Completion date
2023-10-31
Last updated
2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity Dentin

Keywords

Dentinal hypersensitivity, potassium nitrate, diode laser therapy, desensitization, dental pain management

Brief summary

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.

Interventions

COMBINATION_PRODUCTPotassium 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.

DRUGPotassium 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.

Sponsors

University of Pavia
CollaboratorOTHER
University of Genova
CollaboratorOTHER
University of Modena and Reggio Emilia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Reduction in Dentinal Hypersensitivity (Shiff Air Index)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.
Reduction in Dentinal Hypersensitivity (Visual Analog Scale)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

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026