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

Not Applicable

Completed

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

• Registration Number: NCT06669039
• Lead Sponsor: King Abdulaziz University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-17
• Primary Completion: 2024-09-05
• Study Completion: 2024-10-15
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-30
• Status Verified: 2024-11
• Study First Posted: 2024-11-01
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Healthy children (ASA I).
• Ranging in age from 5-9.
• Cooperative (Frankle ++).
• With mandibular first primary molars earmarked for removal owing to factors such as: extensive caries, crown damage, periapical lesions and unsuccessful pulp treatment.

Exclusion Criteria

• Mobile teeth (Grade III).
• Ankylosed teeth.
• Teeth with root resorption (more than 1\3).
• Patients with facial cellulitis and when there is a need for supplemental anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain	Immediately after receiving anesthesia	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"
Stress level	Before and after local anesthesia delivery	Child stress level after receiving either of anesthesia will be determined using salivary cortisol which will be collected by cortisol ELISA kit
Effectiveness	Through dental procedure	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"

Trial Locations

Locations (1)

King AbdulAziz University; 🇸🇦 Jeddah, Saudi Arabia