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

NCT06669039 | Completed FDA Device

• 1 other identifier: 109-05-23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Conventional Inferior Alveolar nerve block

ACTIVE COMPARATOR

Procedure: Inferior Alveolar Nerve Block

Computer-controlled Intraligamentary local anaesthesia

EXPERIMENTAL

Device: Computer-controlled Local Anesthetic delivery system

Interventions

Computer-controlled Local Anesthetic delivery system DEVICE

Local anesthesia will be delivered using Computer-controlled Local Anesthetic delivery system.

Computer-controlled Intraligamentary local anaesthesia

Inferior Alveolar Nerve Block PROCEDURE

Local anesthesia will be delivered using the conventional syringe

Conventional Inferior Alveolar nerve block

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King AbdulAziz University

Jeddah, Jeddah, 21589, Saudi Arabia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Dentist

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: November 17, 2023
• Primary Completion: September 5, 2024
• Study Completion: October 15, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)