Potassium Nitrate Gel and Diode Laser for Dentinal Hypersensitivity

NCT ID: NCT06746558

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-07

Study Completion Date

2023-10-31

Brief Summary

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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

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Conditions

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Hypersensitivity Dentin

Keywords

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Dentinal hypersensitivity potassium nitrate diode laser therapy desensitization dental pain management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Potassium Nitrate Gel with Diode Laser Therapy

Group Type EXPERIMENTAL

Potassium Nitrate Gel and Diode Laser Therapy

Intervention Type 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 Alone

Group Type ACTIVE_COMPARATOR

Potassium Nitrate Gel Alone

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role collaborator

University of Genova

OTHER

Sponsor Role collaborator

University of Modena and Reggio Emilia

OTHER

Sponsor Role lead

Responsible Party

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Alessandro Bruni

DDS, Orthod Spec, PhD, Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Università degli Studi di Pavia, Department of Orthodontics

Pavia, PV, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 33841742 (View on PubMed)

Related Links

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Other Identifiers

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76 2022-0316

Identifier Type: -

Identifier Source: org_study_id