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

Dentin Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06378255
• Other study ID #: PKUSSNCT-23A04
• Secondary ID: PKUSSIRB-2023931
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: April 2024
• Source: Peking University Hospital of Stomatology
• Contact: Qianqian Wang
• Phone: +86-10-62173403
• Email: wangqian0213[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Device:
• Polycation-based new dentinal desensitizer
Dental desensitization treatment
• GLUMA desensitizer
Dental desensitization treatment

Locations

Country	Name	City	State
China	Peking University School and Hospital of Stomatology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Hospital of Stomatology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement of dentin sensitivity induced by air temperature stimulation	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.	At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment