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

Not Applicable

Recruiting

• Conditions: Dentin Sensitivity
• Interventions: Device: Polycation-based new dentinal desensitizer; Device: GLUMA desensitizer

• Registration Number: NCT06378255
• Lead Sponsor: Peking University Hospital of Stomatology

Brief 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.

Study Timeline

• Study Start: 2024-03-20
• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-19
• Last Update Submitted: 2024-04-19
• Study First Posted: 2024-04-22
• Last Update Posted: 2024-04-22
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polycation-based new dentinal desensitizer	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	GLUMA desensitizer	Use according to instructions

Primary Outcome Measures

Name	Time	Method
Improvement of dentin sensitivity induced by probe pressure stimulation	At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment	The severity of dentin sensitivity is assessed using visual analogue scale (VAS) with numbers 0-10 by participants after probe pressure stimulation. Beforehand, the participants were informed that the 10 cm VAS would be used to assess their pain sensitivity, with 0 indicating no pain and 10 indicating the worst pain. Lower scores on the VAS indicate lower sensitivity. Dentin sensitivity was considered to have improved if the visual pain scale (F-VAS) score decreased by 2 or more points from baseline.

Secondary Outcome Measures

Name	Time	Method
Improvement of dentin sensitivity induced by air temperature stimulation	At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment	The severity of dentin sensitivity is assessed using visual analogue scale (VAS) with numbers 0-10 by participants after cold air stimulation. Beforehand, the participants were informed that the 10 cm VAS would be used to assess their pain sensitivity, with 0 indicating no pain and 10 indicating the worst pain. Lower scores on the VAS indicate lower sensitivity. Dentin sensitivity was considered to have improved if the visual pain scale (F-VAS) score decreased by 2 or more points from baseline.

Trial Locations

Locations (1)

Peking University School and Hospital of Stomatology; 🇨🇳 Beijing, Beijing, China