Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity

NCT06923904 | Not Yet Recruiting

• 1 other identifier: PotassiumNitrateLaser
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Our aim will be to evaluate the actual efficacy of diode lasers in laser desensitization by comparing the topical gel Emoform Actisens, containing 5% potassium nitrate, alone and in combination with a diode laser. Dental hypersensitivity (DH) will be assessed pre- (T0) and post-treatment (T1) and at 1 month (T2), 3 months (T3), and 6 months (T4).

Conditions

Dentistry; Desensitization

Keywords

desensitizing treatment; diode laser; oral hygiene; dental sensitivity

Outcome Measures

Primary Outcomes (1)

• degree of dentin hypersensitivity

  assessed using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The DHEQ is a validated self-report tool designed to assess the impact of dentine hy-persensitivity on a patient's daily life, including the intensity and frequency of symptoms as well as the emotional, social, and practical effects on daily activities such as eating, drinking, and oral hygiene practices. The DHEQ consists of 15 questions, with responses rated on a numerical scale from 1 ("strongly disagree") to 7 ("strongly agree"). The final score is calculated out of a total of 105 points, with higher scores indicating a greater im-pact of dentin sensitivity on daily life.

  From enrollment to 6 months after desensitizing procedure

Study Arms (1)

Patients with dental sensitivity

EXPERIMENTAL

With a split-mouth design the dental elements will be divided into the Trial group, treated with a 980 nm diode laser and desensitizing topical gel, and the Control group, treated only with the same gel.

Other: Trial group, treated with a 980 nm diode laser and desensitizing topical gel

Interventions

Trial group, treated with a 980 nm diode laser and desensitizing topical gel OTHER

The study aims to evaluate the actual efficacy of diode lasers in laser desensitization by comparing the topical gel Emoform Actisens, containing 5% potassium nitrate, alone and in combination with a diode laser.

Patients with dental sensitivity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Pavia: lead

MeSH Terms

Interventions

Therapeutics; Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Andrea Scribante, DDS PhD MHA MSc

CONTACT

+39382516209; andrea.scribante@unipv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This will be a randomized clinical trial (RCT) with a split-mouth design

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 11, 2025
• Study Start: April 15, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share