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| Name | Class |
|---|---|
| King Abdulaziz University | OTHER |
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The goal of this is to compare pain and anxiety that may occur during dental anesthesia delivery using conventional dental syringe and the dental anesthesia injector (wireless pain less pen in pediatric dentistry. This is a cross-over randomized clinical trial is to investigate if one technique more efficiant in reducing pain and anaxity. This study could include medically healthy children between the age 6-12 years old requiring restorative dental work. The main question aims to answer [is/are]: Is new painless injector pen better or equal to convintional syrange in reducing both pain and anaxity? Randomization will be generated. Children will recive the first dental treatment under eaither systems then a washout period of 14 days will be carries out, then the same patient will recive the dental treatment on the other side using the 2nd device acording to the manufactuurer instructions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dental anesthesia injector group | Experimental | The dental anesthesia injector |
|
| Conventional Local anaesthesia Syringe | No Intervention | Conventional Local anaesthesia Syringe |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental anesthesia injector | Procedure | Dental anesthesia injector |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Wong-Baker FACES Pain Rating Scale, is a self-report measure consisting of a series of six facial expressions (FACES) representing increasing levels of pain. Scores range from 0 to 10, with 0 (happy face) indicating "no hurt" and 10 ( a crying face) indicating "hurts worst". Higher scores represent greater pain intensity and therefore a worse outcome. | Baseline and immediate post-procedure |
| Anxiety using the Modified Dental Anxiety Scale (MDAS) | The Modified Dental Anxiety Scale is a self-reported measure of dental anxiety consisting of five items, each scored on a 5-point Likert scale. Total scores range from 5 to 25, with 5 indicating no dental anxiety and 25 indicating extreme dental anxiety. Higher scores represent greater dental anxiety and therefore a worse outcome. | Baseline and immediate post- procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdulaziz University | Jeddah | Saudi Arabia |
Due to patient privacy
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 1, 2024 | Jun 4, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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