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The aim of this study to evaluate the effectiveness of CC-ILA using Super pen in eliminating pain during the extraction of mandibular primary molars, compared to the conventional Inferior Alveolar Nerve Block (IANB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A) Experimental Group (CC-ILA using Super Pen) | Experimental | A) Experimental Group (CC-ILA using Super Pen)
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| B) Control Group (Conventional IANB Technique) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Group (CC-ILA using Super Pen) | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Heart rate will be monitored using a pulse oximeter at baseline, during LA injection, and during extraction. Readings will be recorded every two minutes and mean values will be calculated. | immediately after the procedure (within the same treatment visit) |
| Oxygen saturation | Oxygen saturation will be monitored using a pulse oximeter at baseline, during LA injection, and during extraction. Readings will be recorded every two minutes and mean values will be calculated. | immediately after the procedure (within the same treatment visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Pain assessment | Pain will be assessed using the Sound, Eye, and Motor (SEM) Scale. Each component will be graded from 1 (comfort) to 4 (severe discomfort) by the operator and the independent outcome assessor evaluator reviewing video recordings. | immediately after the procedure (within the same treatment visit). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Assessment | Parents will be questioned during the 24-hour follow-up regarding any unusual symptoms. | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shatha M Alharthi, BDS | Contact | +966541077444 | shatha.al-harthi@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University, Egypt | Alexandria | Egypt |
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Single (participant)
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| Subjective Pain assessment |
Pain perception will be recorded after anesthesia and Extraction using a modified facial expression scale. Children will choose from three schematic faces representing satisfaction, indifference, or dissatisfaction. |
| immediately after the procedure (within the same treatment visit). |