Clinical trial NCT06378255: Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity
Official title: Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Dentin Sensitivity
Tooth desensitizer
Lead sponsor: Peking University Hospital of Stomatology
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improvement of dentin sensitivity induced by probe pressure stimulation
timeFrame: At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment
Secondary outcomes:
measure: Improvement of dentin sensitivity induced by air temperature stimulation
timeFrame: At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University School and Hospital of Stomatology
state: Beijing
Study officials:
References: