| Registry | NCT06378255 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 40 (Actual) |
| Sponsor | Peking University Hospital of Stomatology (Other) |
| Conditions | Dentin Sensitivity |
| Interventions | Polycation-based new dentinal desensitizer, GLUMA desensitizer (Device) |
| Dates | start 2024-03-20, primary completion 2024-12-22, completion 2025-08-11, first posted 2024-04-22, last updated 2026-02-18 |
| Locations | 1 site in China |
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Evaluate the safety and clinical efficacy of new dental desensitizers in the treatment of dentin sensitivity, including the relief of sensitivity symptoms and the duration of efficacy.
This is a randomized, single-blind and controlled study to include 40 patients with dentin sensitivity. The study will be a randomized controlled trial with split mouth control, with two quadrants of the same patient as test and control groups, the test group being the group using the new desensitizer and the control group being the group with the clinically used desensitizer (Gruma desensitizer). Improvement in dentin sensitivity symptoms was the primary outcome indicator observed. Dentin sensitivity was assessed by evaluating the reduction in dentin sensitivity VAS scores at immediately, 1 month, 3 months, and 6 months points after the desensitization treatment, and by evaluating the subjects' self-reported relief of sensitivity. Safety was assessed by evaluating appliance defects and adverse events at the immediately,1-, 3-, and 6-months points after the desensitization treatment.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Polycation-based new dentinal desensitizer | Experimental | Device: Polycation-based new dentinal desensitizer | Use a cotton ball or brush to apply a small amount of desensitizing agent to the sensitive tooth surface for about 1 minute and wait for 2 minutes. Excess gel is then wiped off the surface. |
| GLUMA desensitizer | Placebo comparator | Device: GLUMA desensitizer | Use according to instructions |
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria: * Dentin Hypersensitivity, with Vas scoreā„4 points and the normal pulp viability * dentin-sensitive tooth in at least 2 different quadrants of the mouth (neck enamel dentin exposure or maxillofacial abrasion within the middle layer of dentin). * in good overall health * participants informed consent. Exclusion Criteria: * gastroesophageal reflux * Dental caries, wedge defects, crowns or large fillings. * Received dentin sensitivity desensitization treatment or used desensitization mouthwash within 1 month. * Received systematic periodontal therapy or periodontal surgery within 3 months, ongoing orthodontic treatment, and medical treatment, including long-term use of anti-inflammatory, analgesic, and psychotropic medications. * Pregnancy or breastfeeding. * Participated in other clinical trials in the past 3 months.
| Facility | City | Country | Status |
|---|---|---|---|
| Peking University School and Hospital of Stomatology | Beijing, Beijing Municipality | China |