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

NCT ID: NCT06378255

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2025-09-01

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.

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Polycation-based new dentinal desensitizer

Intervention Type: DEVICE

Dental desensitization treatment

GLUMA desensitizer

Use according to instructions

Group Type: PLACEBO_COMPARATOR

GLUMA desensitizer

Intervention Type: DEVICE

Dental desensitization treatment

Interventions

Polycation-based new dentinal desensitizer

Dental desensitization treatment

Intervention Type: DEVICE

GLUMA desensitizer

Dental desensitization treatment

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Hospital of Stomatology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PKUSSIRB-202393160

Identifier Type: OTHER

Identifier Source: secondary_id

Z221100007422088

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PKUSSNCT-23A04

Identifier Type: -

Identifier Source: org_study_id