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| ID | Type | Description | Link |
|---|---|---|---|
| PKUSSIRB-202393160 | Other Identifier | Ethics Committee of PKUSH of Stomatology | |
| Z221100007422088 | Other Grant/Funding Number | The SFP for clinical CDTT in capital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| GLUMA desensitizer | Placebo Comparator | Use according to instructions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polycation-based new dentinal desensitizer | Device | Dental desensitization treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University School and Hospital of Stomatology | Beijing | Beijing Municipality | 100081 | China |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| GLUMA desensitizer | Device | Dental desensitization treatment |
|
| At Baseline and 10 minutes, 1 month, 3 months, 6 months after desensitization treatment |