Potassium Nitrate Gel and Diode Laser for Dentinal Hypersensitivity

NCT06746558 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-12-24

No results posted yet for this study

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.

Conditions

  • Hypersensitivity Dentin

Interventions

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.

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.

Sponsors & Collaborators

  • University of Pavia

    collaborator OTHER
  • University of Genova

    collaborator OTHER
  • University of Modena and Reggio Emilia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-07
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06746558 on ClinicalTrials.gov