Potassium Nitrate Gel and Diode Laser for Dentinal Hypersensitivity

Not Applicable

Completed

• Conditions: Hypersensitivity Dentin
• Interventions: Drug: Potassium Nitrate Gel Alone; Combination Product: Potassium Nitrate Gel and Diode Laser Therapy

• Registration Number: NCT06746558
• Lead Sponsor: University of Modena and Reggio Emilia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-07
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Potassium Nitrate Gel Alone	Potassium Nitrate Gel Alone	-
Potassium Nitrate Gel with Diode Laser Therapy	Potassium Nitrate Gel and Diode Laser Therapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Università degli Studi di Pavia, Department of Orthodontics; 🇮🇹 Pavia, PV, Italy