Combined Use of Potassium Nitrate Gel and Diode Laser for Dentin Hypersensitivity
- Conditions
- Dentin Hypersensitivity
- Interventions
- Drug: Potassium Nitrate GelDevice: Diode Laser (Active)Device: Diode Laser (Sham)
- Registration Number
- NCT06967818
- Lead Sponsor
- University of Pavia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 23
- Patients with good oral hygiene
- Presence of at least one tooth affected by dentin hypersensitivity
- Signed informed consent
- Use of analgesic medication
- Ongoing orthodontic treatment
- Non-vital (endodontically treated) teeth
- Teeth with restorative materials on the surface
- Pregnant or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Potassium Nitrate Gel + Active Diode Laser Potassium Nitrate Gel Participants receive topical application of a 5% potassium nitrate gel (Emofrom Actisens), followed by treatment with an active 980 nm diode laser (1.5 W/cm² for 1 minute without contact and 1 minute with contact, using a sweeping motion perpendicular to the long axis of the tooth). Sensitivity is measured at baseline (T0), immediately after treatment (T1), and at 1 month (T2), 3 months (T3), and 6 months (T4). Potassium Nitrate Gel + Active Diode Laser Diode Laser (Active) Participants receive topical application of a 5% potassium nitrate gel (Emofrom Actisens), followed by treatment with an active 980 nm diode laser (1.5 W/cm² for 1 minute without contact and 1 minute with contact, using a sweeping motion perpendicular to the long axis of the tooth). Sensitivity is measured at baseline (T0), immediately after treatment (T1), and at 1 month (T2), 3 months (T3), and 6 months (T4). Potassium Nitrate Gel + Sham Diode Laser Potassium Nitrate Gel Participants receive the same topical application of 5% potassium nitrate gel (Emofrom Actisens), followed by treatment with an inactive (sham) 980 nm diode laser using the same procedure and duration as in the active group, but without laser energy. Sensitivity is measured at the same timepoints: baseline (T0), immediately after treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4). Potassium Nitrate Gel + Sham Diode Laser Diode Laser (Sham) Participants receive the same topical application of 5% potassium nitrate gel (Emofrom Actisens), followed by treatment with an inactive (sham) 980 nm diode laser using the same procedure and duration as in the active group, but without laser energy. Sensitivity is measured at the same timepoints: baseline (T0), immediately after treatment (T1), 1 month (T2), 3 months (T3), and 6 months (T4).
- Primary Outcome Measures
Name Time Method Change in Dentin Sensitivity Measured by Schiff Air Index Baseline (T0), Immediately Post-Treatment (T1), 1 Month (T2), 3 Months (T3), and 6 Months (T4) The Schiff Air Index is used to assess sensitivity to evaporative stimuli (air blast). Scores range from 0 to 3, with higher scores indicating greater sensitivity. Measurements will be performed at baseline, immediately after treatment, and during follow-up visits at 1, 3, and 6 months. The primary endpoint is the change in Schiff score from baseline to 6 months.
- Secondary Outcome Measures
Name Time Method Change in Pain Perception Measured by Visual Analog Scale (VAS) Baseline (T0), Immediately Post-Treatment (T1), 1 Month (T2), 3 Months (T3), and 6 Months (T4) The VAS is a 10 cm horizontal line on which participants indicate their perceived pain during air stimulus, ranging from 0 (no pain) to 10 (worst imaginable pain). The secondary outcome is the reduction in VAS score between baseline and follow-up visits.
Change in Quality of Life Related to Dentin Hypersensitivity Measured by DHEQ Questionnaire Baseline (T0) and 6 Months Post-Treatment (T4) The Dentine Hypersensitivity Experience Questionnaire (DHEQ) assesses the impact of hypersensitivity on patients' daily lives. It includes 15 items scored from 1 to 7, with a total score range of 15 to 105. Higher scores indicate greater perceived impact. The outcome is the change in total score from baseline to 6 months.
Trial Locations
- Locations (1)
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
🇮🇹Pavia, Lombardy, Italy