Dentin HypersensitivityNCT07197437
Efficacy of Universal Bonding Agents as Desensitizers
A study testing Hybrid Coat desensitizer and Single Bond Universal as desensitizer in people with Dentin Hypersensitivity, run by Peking University Hospital of Stomatology at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if the adhesive Single Bond Universal works to treat dentin hypersensitivity in adults. It will also learn about the durability of Single Bond Universal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dentin Hypersensitivity
- What is being tested?
- Hybrid Coat desensitizer and Single Bond Universal as desensitizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2023to 7 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged ≥ 18 years who were able to provide written informed consent.
- Participants confirmed as healthy according to the examiner, without clinically significant diseases that could interfere with study outcomes.
- Participants with symptoms of dentin hypersensitivity affecting symmetrical teeth on both sides due to gingival recession.
- Symptomatic teeth without caries, filling materials, or use as abutments for removable partial dentures.
Who cannot join
- Individuals with dentin hypersensitivity caused by other factors (e.g., erosion or wedge-shaped defects).
- Individuals with teeth exhibiting deep periodontal pockets (≥ 4 mm) or with a difference in gingival recession between the two symptomatic teeth of ≥ 1 mm.
- Individuals who had received treatment or used toothpaste for dentin hypersensitivity within the previous 4 weeks.
- Individuals who had undergone tooth bleaching or periodontal treatment within the previous 4 weeks.
- Individuals who had undergone cervical restorative treatment. Individuals who had taken nonsteroidal anti-inflammatory drugs or narcotic analgesics within the previous week.
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
Official title: Clinical Efficacy of Resin Based Coating Materials for Protecting Dental Root
The goal of this clinical trial is to learn if the adhesive Single Bond Universal works to treat dentin hypersensitivity in adults. It will also learn about the durability of Single Bond Universal. The main questions it aims to answer are:
Does Single Bond Universal has the function to treat dentin hypersensitivity in adults? Researchers will compare Single Bond Universal to a traditional desensitizer Hybrid Coat to see which one has higher efficiency and longer durability.
Read more
Participants will:
Receive the treatment of Single Bond Universal or Hybrid Coat at the first visit.
Visit the clinic at 1, 3, 6, 9, 12 months for follow-up evaluation. Reassess dentin sensitivity at each visit and record in terms of VAS score.
Read the detailed description
This is a randomized, double-blind and controlled study to include 14 patients with dentin sensitivity. The study is a randomized controlled trial with split mouth control, with symmetrical tooth positions on both sides of the same patient as test and control groups, the test group being the group using the universal bonding agent and the control group being the group using the clinically used desensitizer (Hybrid Coat). 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, 6 months, 9 months and 12 months points after the desensitization treatment. Safety was assessed by evaluating appliance defects and adverse events at the same time points after the desensitization treatment.
- Conditions
- Dentin Hypersensitivity
- Being tested
- Hybrid Coat desensitizer, Single Bond Universal as 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.
Hybrid Coat desensitizerDevice
Dental desensitization treatment
Single Bond Universal as desensitizerDevice
Dental desensitization treatment
| Study group | Role | What they receive |
|---|---|---|
| Single Bond Universal | Experimental | Use a microbrush to apply a drop of agent to the sensitive tooth surface for 20 seconds and light cure. Receives: Device: Single Bond Universal as desensitizer |
| Hybrid Coat | Active comparator | Use a coated cotton pellet to apply a drop of agent to the sensitive tooth surface for 20 seconds and light cure. Receives: Device: Hybrid Coat desensitizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment efficacy of the tooth: the change in VAS score before and after desensitization
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: from enrollment to the last follow-up (12 months after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start27 Feb 2023
- Primary completion7 Mar 2025
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dentin HypersensitivityStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Hospital of Stomatology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xue Cai, Principal investigator, Peking University School and Hospital of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197437
- Sponsor's protocol ID
- PKUSSIRB-202273039
- Other IDs
- PKUSSIRB-202273039, MR-11-22-005868
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol and results will be displayed in a published article. Other dataset containing participants' information cannot be made public according to the requirements of the informed consent form.
Publications
Cai X, Cao R, Wang X. Efficacy of universal bonding agents as desensitizers: in vitro and in vivo studies. BMC Oral Health. 2026 Jan 29;26(1):357. doi: 10.1186/s12903-026-07767-z.
PubMed 41612333
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Resin Based Coating Materials for Protecting Dental Root
- ClinicalTrials.gov ID
- NCT07197437
- Acronym / sponsor ID
- PKUSSIRB-202273039
- Conditions
- Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Peking University Hospital of StomatologyUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 29 Sep 2025 (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.
The goal of this clinical trial is to learn if the adhesive Single Bond Universal works to treat dentin hypersensitivity in adults. It will also learn about the durability of Single Bond Universal. The main questions it aims to answer are:
Does Single Bond Universal has the function to treat dentin hypersensitivity in adults? Researchers will compare Single Bond Universal to a traditional desensitizer Hybrid Coat to see which one has higher efficiency and longer durability.
Participants will:
Receive the treatment of Single Bond Universal or Hybrid Coat at the first visit.
Visit the clinic at 1, 3, 6, 9, 12 months for follow-up evaluation. Reassess dentin sensitivity at each visit and record in terms of VAS score.
Detailed description
This is a randomized, double-blind and controlled study to include 14 patients with dentin sensitivity. The study is a randomized controlled trial with split mouth control, with symmetrical tooth positions on both sides of the same patient as test and control groups, the test group being the group using the universal bonding agent and the control group being the group using the clinically used desensitizer (Hybrid Coat). 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, 6 months, 9 months and 12 months points after the desensitization treatment. Safety was assessed by evaluating appliance defects and adverse events at the same time 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 |
|---|---|---|
| Single Bond Universal | Experimental | Device: Single Bond Universal as desensitizerUse a microbrush to apply a drop of agent to the sensitive tooth surface for 20 seconds and light cure. |
| Hybrid Coat | Active comparator | Device: Hybrid Coat desensitizerUse a coated cotton pellet to apply a drop of agent to the sensitive tooth surface for 20 seconds and light cure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged ≥ 18 years who were able to provide written informed consent.
- Participants confirmed as healthy according to the examiner, without clinically significant diseases that could interfere with study outcomes.
- Participants with symptoms of dentin hypersensitivity affecting symmetrical teeth on both sides due to gingival recession.
- Symptomatic teeth without caries, filling materials, or use as abutments for removable partial dentures.
Key exclusion criteria (5 listed)
- Individuals with dentin hypersensitivity caused by other factors (e.g., erosion or wedge-shaped defects).
- Individuals with teeth exhibiting deep periodontal pockets (≥ 4 mm) or with a difference in gingival recession between the two symptomatic teeth of ≥ 1 mm.
- Individuals who had received treatment or used toothpaste for dentin hypersensitivity within the previous 4 weeks.
- Individuals who had undergone tooth bleaching or periodontal treatment within the previous 4 weeks.
- Individuals who had undergone cervical restorative treatment. Individuals who had taken nonsteroidal anti-inflammatory drugs or narcotic analgesics within the previous week.
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 |
|---|---|---|
| Hybrid Coat desensitizerDental desensitization treatment | Device | Hybrid Coat |
| Single Bond Universal as desensitizerDental desensitization treatment | Device | Single Bond Universal |
Primary outcome
treatment efficacy of the tooth: the change in VAS score before and after desensitization
Time frame: from enrollment to the last follow-up (12 months after 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.
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 29 Sep 2025.
- Derived from this study: PubMed 41612333Cai X, Cao R, Wang X. Efficacy of universal bonding agents as desensitizers: in vitro and in vivo studies. BMC Oral Health. 2026 Jan 29;26(1):357. doi: 10.1186/s12903-026-07767-z.
- Individual participant dataSharing planned: No. The protocol and results will be displayed in a published article. Other dataset containing participants' information cannot be made public according to the requirements of the informed consent form.
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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.
Xue Cai principal investigator
Peking University School and Hospital of Stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Coat desensitizer and Single Bond Universal as desensitizer in people with Dentin Hypersensitivity, 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 5 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 29 Sep 2025. 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. 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?
treatment efficacy of the tooth: the change in VAS score before and after desensitization (time frame: from enrollment to the last follow-up (12 months after treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07197437, which also lists 1 linked publication.
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 29 Sep 2025.