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

Last updated: May 28, 2025
Sponsor: Peking University Hospital of Stomatology
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Allergy (Pediatric)

Allergies & Asthma

Allergy

Treatment

Polycation-based new dentinal desensitizer

GLUMA desensitizer

Clinical Study ID

NCT06378255
PKUSSNCT-23A04
PKUSSIRB-202393160
Z221100007422088
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Dentin Hypersensitivity, with Vas score≥4 points and the normal pulp viability

  • dentin-sensitive tooth in at least 2 different quadrants of the mouth (neck enameldentin exposure or maxillofacial abrasion within the middle layer of dentin).

  • in good overall health

  • participants informed consent.

Exclusion

Exclusion Criteria:

  • gastroesophageal reflux

  • Dental caries, wedge defects, crowns or large fillings.

  • Received dentin sensitivity desensitization treatment or used desensitizationmouthwash within 1 month.

  • Received systematic periodontal therapy or periodontal surgery within 3 months,ongoing orthodontic treatment, and medical treatment, including long-term use ofanti-inflammatory, analgesic, and psychotropic medications.

  • Pregnancy or breastfeeding.

  • Participated in other clinical trials in the past 3 months.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Polycation-based new dentinal desensitizer
Phase:
Study Start date:
March 20, 2024
Estimated Completion Date:
September 01, 2025

Study 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.

Connect with a study center

  • Peking University School and Hospital of Stomatology

    Beijing, Beijing 100081
    China

    Site Not Available

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