NCT06669039

Comparison of the Computer Controlled and Conventional Local Anesthesia Techniques in Primary Molar Extraction in Children Aged 5 to 9 Years Old

Comparison of Computer Controlled Intra-ligamentary Local Anesthesia and Conventional Inferior Alveolar Nerve Block in Primary Molars Extractions - Randomized Clinical Trail

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: King Abdulaziz University · Academic / Other
• Sex: All
• Age: 5 Years – 9 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Computer-controlled Intraligamentary Anaesthesia
• Inferior Alveolar Nerve Block
• Pain Perception
• Anesthesia Effectiveness

Interventions

Type	Name	Description
DEVICE	Computer-controlled Local Anesthetic delivery system	Local anesthesia will be delivered using Computer-controlled Local Anesthetic delivery system.
PROCEDURE	Inferior Alveolar Nerve Block	Local anesthesia will be delivered using the conventional syringe

Timeline

• Start date: 2023-11-17
• Primary completion: 2024-09-05
• Completion: 2024-10-15
• First posted: 2024-11-01
• Last updated: 2024-11-05

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated device study