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Completed

NCT Number: NCT06378255

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polycation-based new dentinal desensitizer

Device

Dental desensitization treatment

GLUMA desensitizer

Device

Dental desensitization treatment

Primary outcomes

  1. Improvement of dentin sensitivity induced by probe pressure stimulation

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

    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.

Secondary outcomes

  1. Improvement of dentin sensitivity induced by air temperature stimulation

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

    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.

Sponsors and collaborators

Lead sponsor

Peking University Hospital of Stomatology

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 22, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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