Dentin SensitivityNCT06378255
Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity
A study testing Polycation-based new dentinal desensitizer and GLUMA desensitizer in people with Dentin Sensitivity, run by Peking University Hospital of Stomatology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Polycation-based new dentinal desensitizer and GLUMA desensitizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2024to 11 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Peking University School and Hospital of Stomatology
Beijing, Beijing Municipality, 100081
About this study
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.
Read the 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.
- Conditions
- Dentin Sensitivity
- Being tested
- Polycation-based new dentinal desensitizer, GLUMA desensitizer
- Keywords
- Dentin Sensitivity, Tooth desensitizer
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polycation-based new dentinal desensitizerDevice
Dental desensitization treatment
GLUMA desensitizerDevice
Dental desensitization treatment
| Study group | Role | What they receive |
|---|---|---|
| Polycation-based new dentinal desensitizer | Experimental | 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. Receives: Device: Polycation-based new dentinal desensitizer |
| GLUMA desensitizer | Placebo comparator | Use according to instructions Receives: Device: GLUMA desensitizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment
Secondary outcomes (1)
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.
Measured: At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start20 Mar 2024
- Primary completion22 Dec 2024
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Hospital of Stomatology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378255
- Sponsor's protocol ID
- PKUSSNCT-23A04
- Other IDs
- PKUSSIRB-202393160, Z221100007422088
- Status last verified
- Feb 2026
- First submitted
- 16 Apr 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity
- ClinicalTrials.gov ID
- NCT06378255
- Acronym / sponsor ID
- PKUSSNCT-23A04
- Conditions
- Dentin Sensitivity
- Keywords
- Dentin Sensitivity, Tooth desensitizer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking University Hospital of StomatologyUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polycation-based new dentinal desensitizer | Experimental | Device: Polycation-based new dentinal desensitizerUse 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. |
| GLUMA desensitizer | Placebo comparator | Device: GLUMA desensitizerUse according to instructions |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polycation-based new dentinal desensitizerDental desensitization treatment | Device | Polycation-based new dentinal desensitizer |
| GLUMA desensitizerDental desensitization treatment | Device | GLUMA desensitizer |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polycation-based new dentinal desensitizer and GLUMA desensitizer in people with Dentin Sensitivity, run by Peking University Hospital of Stomatology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.