Potassium Nitrate Gel and Diode Laser for Dentinal Hypersensitivity

NCT06746558 | Completed

• 1 other identifier: 76 2022-0316
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypersensitivity Dentin

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Changes in Quality of Life (Dentine Hypersensitivity Experience Questionnaire)

  Baseline (T0) and 6 months (T4)

Study Arms (2)

Potassium Nitrate Gel with Diode Laser Therapy

EXPERIMENTAL

Combination Product: Potassium Nitrate Gel and Diode Laser Therapy

Potassium Nitrate Gel Alone

ACTIVE COMPARATOR

Drug: Potassium Nitrate Gel Alone

Interventions

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 with Diode Laser Therapy

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.

Potassium Nitrate Gel Alone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead
• University of Pavia: collaborator
• University of Genova: collaborator

Study Sites (1)

Università degli Studi di Pavia, Department of Orthodontics

Pavia, PV, Italy

Location

Related Publications (1)

• 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.

  PMID: 33841742 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

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: DDS, Orthod Spec, PhD, Research Fellow

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 24, 2024
• Study Start: January 7, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)