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NCT Number: NCT06923904

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This will be a randomized clinical trial (RCT) with a split-mouth design, involving 12 subjects, with two parallel groups. 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. DH will be assessed using the Shiff Air Index (SAI) and Visual Analog Scale (VAS).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria will be as follows: (a) a good standard of home oral hygiene and (b) at least two teeth affected by DH.

The exclusion criteria will be: (a) individuals taking pain relievers; (b) individuals undergoing orthodontic treatment; (c) non-vital teeth; (d) teeth with restorative materials; and (e) pregnant or breastfeeding women

Treatment and study plan

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.

Primary outcomes

  1. degree of dentin hypersensitivity

    Time frame: From enrollment to 6 months after desensitizing procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Scribante, DDS PhD MHA MSc

CONTACT

[email protected]

+39382516209

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Acronym: PotassiumNitra

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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