Clinical trial NCT06967818: Combined Use of Potassium Nitrate Gel and Diode Laser for Dentin Hypersensitivity
Official title: Clinical Evaluation of the Combined Effect of a Potassium Nitrate-Based Gel and Diode Laser in the Treatment of Dentin Hypersensitivity: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dentin Hypersensitivity
Keywords: Dentin Hypersensitivity
Potassium Nitrate
Diode Laser
Dental Pain
Desensitizing Treatment
Visual Analog Scale
Schiff Air Index
Laser Therapy
Tooth Sensitivity
Noninvasive Dentistry
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to evaluate the efficacy of the combined use of a diode laser and a potassium nitrate-based desensitizing gel in reducing dentin hypersensitivity in adult patients. Patients who meet the eligibility criteria and for whom informed consent has been obtained will be enrolled and assessed at five timepoints. At baseline (T0), all patients will undergo a professional dental cleaning, collection of medical and dental history, a full periodontal and dental charting, and completion of the Dentine Hypersensitivity Experience Questionnaire (DHEQ) to assess the impact of hypersensitivity on quality of life. Sensitivity will be measured using the Schiff Air Index and the Visual Analog Scale (VAS) in response to air stimulation. At T1, patients will receive the assigned treatment based on randomization. In the test group, the hypersensitive teeth will be treated with topical application of a potassium nitrate gel (Emoform Actisens, 5%) followed by irradiation with a 980 nm diode laser (1.5 W/cm² for 1 minute without contact, then 1 minute with contact and sweeping motion). In the control group, the same potassium nitrate gel will be applied, but the laser will remain inactive (sham laser). Immediately after treatment, the Schiff Air Index and VAS will be reassessed. Follow-up evaluations will be conducted at T2 (1 month after treatment), T3 (3 months), and T4 (6 months). At each follow-up visit, sensitivity will again be measured using the Schiff and VAS indices. At the final follow-up (T4), the DHEQ questionnaire will be administered a second time to assess changes in the patients' perceived impact of dentin hypersensitivity on daily life. Patients are randomized into two groups: Test group: potassium nitrate gel plus active diode laser (980 nm); Control group: potassium nitrate gel plus sham diode laser (inactive). The study aims to determine whether the addition of diode laser irradiation enhances the desensitizing effect of the potassium nitrate gel in both the short and long term (from T1 to T4), as measured by changes in Schiff Air Index, VAS scores, and DHEQ results.


Eligibility criteria: Inclusion Criteria:

* Patients with good oral hygiene
* Presence of at least one tooth affected by dentin hypersensitivity
* Signed informed consent

Exclusion Criteria:

* Use of analgesic medication
* Ongoing orthodontic treatment
* Non-vital (endodontically treated) teeth
* Teeth with restorative materials on the surface
* Pregnant or breastfeeding women

Primary outcomes:
measure: Change in Dentin Sensitivity Measured by Schiff Air Index
timeFrame: Baseline (T0), Immediately Post-Treatment (T1), 1 Month (T2), 3 Months (T3), and 6 Months (T4)
Secondary outcomes:
measure: Change in Pain Perception Measured by Visual Analog Scale (VAS)
timeFrame: Baseline (T0), Immediately Post-Treatment (T1), 1 Month (T2), 3 Months (T3), and 6 Months (T4)
measure: Change in Quality of Life Related to Dentin Hypersensitivity Measured by DHEQ Questionnaire
timeFrame: Baseline (T0) and 6 Months Post-Treatment (T4)
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: