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| ID | Type | Description | Link |
|---|---|---|---|
| HĐ | Other Identifier | University of Medicine and Pharmacy at Ho Chi Minh City |
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The goal of this clinical study is to compare patients' self-reported pain and mental stress during infiltration anesthesia between conventional syringe and Dentapen.
Outcome 1: VAS score of self-reported pain during dental anesthesia Outcome 2: Heart rate variability during dental anesthesia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dentapen | Experimental | On the experimental side, researcher used Dentapen, a Computer-Controlled Local Anaesthetic Delivery device, to deliver anesthesia for patients. |
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| Control | Active Comparator | This arm was admistered local anesthesia with conventional syringe |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computer controlled local anesthesia delivery device (Dentapen) | Device | The participants were delivered local anesthesia using a computer-controlled local anesthesia delivery (CCLAD) device. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | Heart rate variability (HRV) is is the precise measure of the variation in time (milliseconds) between consecutive heartbeats. HRV is measured using a device around patient chest. | From enrollment to the end of tooth extraction treatment at 4 weeks. Each patient experienced two extraction treatments with 4-week interval. |
| Self-reported pain | Patients reported how much pain intensity that they feel during dental anesthesia by using a visual analogue scale. Scale value ranges from 0 (no pain) to 100 (maximum pain). | Patients reported right after dental anesthesia delivery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Medicine and Pharmacy at Ho Chi Minh City | Ho Chi Minh City | 72714 | Vietnam |
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A split-mouth clinical trial in which one side is injected with conventional dental syringe, the other side is injected with Dentapen.
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Participants were covered their face with a drape for masking the instrument was using.
| Control | Device | Conventional syrine was used to administer local anesthesia. Participants in this group would received manual anesthesia. |
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