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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06378255
Other study ID # PKUSSNCT-23A04
Secondary ID PKUSSIRB-2023931
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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