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The goal of this clinical trial is to assess pain perception, child stress level and compare the effectiveness between periodontal ligament anesthesia using Computer-controlled Local Anesthetic delivery system and the Conventional Inferior Alveolar Nerve Block during extraction of the primary molars.
The main questions it aims to answer are:
Is there a difference in pain perception, child stress level and anesthesia effectiveness between the CC-ILA system and the traditional syringe when administering IANB in pediatric patients undergoing primary molar extractions.
Researchers will compare CC-ILA system to traditional syringe when administering IANB to see if there a difference in pain perception, child stress level and anesthesia effectiveness.
Participants will:
Have their lower first primary molar extracted by receiving either periodontal ligament anesthesia using computer-controlled local anesthetic delivery system or the conventional inferior alveolar nerve bock.
Pain perception during the anesthesia process was measured using both objective criteria through the Sound-Eye-Motor scale and subjective assessment using Wong-Baker Faces Pain Rating Scale. Salivary cortisol level will be used to determine child stress level. The efficacy of anesthesia at various stages of the extraction procedure was evaluated using the Sound-Eye-Motor scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Inferior Alveolar nerve block | Active Comparator |
| |
| Computer-controlled Intraligamentary local anaesthesia | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-controlled Local Anesthetic delivery system | Device | Local anesthesia will be delivered using Computer-controlled Local Anesthetic delivery system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Wong-Baker Faces Pain Rating Scale The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst". | Immediately after receiving anesthesia |
| Pain | Sound eye motor scale An observational scale uses child sound, eye and body movement to reflect on child comfort where score 1 reflect "comfort" and score 4 reflect "pain" | Immediately after receiving anesthesia |
| Stress level | Child stress level after receiving either of anesthesia will be determined using salivary cortisol which will be collected by cortisol ELISA kit | Before and after local anesthesia delivery |
| Effectiveness | Sound eye motor scale An observational scale uses child sound, eye and body movement to reflect on child comfort where score 1 reflect "comfort" and score 4 reflect "pain" | Through dental procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King AbdulAziz University | Jeddah | Jeddah | 21589 | Saudi Arabia |
Pain perception scores, operator pain assessment scores and the anesthesia effectiveness scores.
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| Inferior Alveolar Nerve Block | Procedure | Local anesthesia will be delivered using the conventional syringe |
|