NCT06378255

Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Peking University Hospital of Stomatology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dentin Sensitivity

Interventions

Type	Name	Description
DEVICE	Polycation-based new dentinal desensitizer	Dental desensitization treatment
DEVICE	GLUMA desensitizer	Dental desensitization treatment

Timeline

• Start date: 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 across 1 country: China