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| ID | Type | Description | Link |
|---|---|---|---|
| PKUSSIRB-202273039 | Other Identifier | the Ethical Committee of Peking University School and Hospital of Stomatology | |
| MR-11-22-005868 | Other Identifier | https://www.medicalresearch.org.cn |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Bond Universal | Experimental | Use a microbrush to apply a drop of agent to the sensitive tooth surface for 20 seconds and light cure. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Coat desensitizer | Device | Dental desensitization treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from enrollment to the last follow-up (12 months after treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xue Cai | Peking University School and Hospital of Stomatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University School and Hospital of Stomatology | Beijing | Beijing Municipality | 100081 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41612333 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Single Bond Universal as desensitizer |
| Device |
Dental desensitization treatment |
|