Clinical trial NCT06746558: Potassium Nitrate Gel and Diode Laser for Dentinal Hypersensitivity
Official title: Clinical Evaluation of the Combined Effect of a Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypersensitivity Dentin
Keywords: Dentinal hypersensitivity
potassium nitrate
diode laser therapy
desensitization
dental pain management
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
Collaborators: name: University of Pavia
name: University of Genova
First posted: 2024-12-24
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in Dentinal Hypersensitivity (Shiff Air Index)
timeFrame: Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4)
measure: Reduction in Dentinal Hypersensitivity (Visual Analog Scale)
timeFrame: Baseline (T0), immediately post-treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4).
Secondary outcomes:
measure: Changes in Quality of Life (Dentine Hypersensitivity Experience Questionnaire)
timeFrame: Baseline (T0) and 6 months (T4)
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Università degli Studi di Pavia, Department of Orthodontics
state: PV
Study officials:
References:
citation: 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.