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

NCT06378255 | Completed

• 3 other identifiers: PKUSSNCT-23A04PKUSSIRB-202393160Z221100007422088
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Keywords

Dentin Sensitivity; Tooth desensitizer

Outcome Measures

Primary Outcomes (1)

• Improvement of dentin sensitivity induced by probe pressure stimulation

  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.

  At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment

Secondary Outcomes (1)

• Improvement of dentin sensitivity induced by air temperature stimulation

  At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment

Study Arms (2)

Polycation-based new dentinal desensitizer

EXPERIMENTAL

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.

Device: Polycation-based new dentinal desensitizer

GLUMA desensitizer

PLACEBO COMPARATOR

Use according to instructions

Device: GLUMA desensitizer

Interventions

Polycation-based new dentinal desensitizer DEVICE

Dental desensitization treatment

Polycation-based new dentinal desensitizer

GLUMA desensitizer DEVICE

Dental desensitization treatment

GLUMA desensitizer

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Hospital of Stomatology: lead

Study Sites (1)

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 22, 2024
• Study Start: March 20, 2024
• Primary Completion: December 22, 2024
• Study Completion: August 11, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CN (1)