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

Peking University Hospital of Stomatology

Status: Active, not recruiting

Conditions: Dentin Sensitivity

Treatments: Device: GLUMA desensitizer; Device: Polycation-based new dentinal desensitizer

Study type: Interventional

Funder types: Other

Identifiers

NCT06378255

PKUSSNCT-23A04

Z221100007422088 (Other Grant/Funding Number)

PKUSSIRB-202393160 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups, including a placebo group

Polycation-based new dentinal desensitizer

Experimental group

Description:

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.

Treatment:

Device: Polycation-based new dentinal desensitizer

GLUMA desensitizer

Placebo Comparator group

Description:

Use according to instructions

Treatment:

Device: GLUMA desensitizer