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

NCT ID: NCT06669039

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-17
• Study Completion Date: 2024-10-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Conventional Inferior Alveolar nerve block

Group Type: ACTIVE_COMPARATOR

Inferior Alveolar Nerve Block

Intervention Type: PROCEDURE

Local anesthesia will be delivered using the conventional syringe

Computer-controlled Intraligamentary local anaesthesia

Group Type: EXPERIMENTAL

Computer-controlled Local Anesthetic delivery system

Intervention Type: DEVICE

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

Interventions

Computer-controlled Local Anesthetic delivery system

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

Intervention Type: DEVICE

Inferior Alveolar Nerve Block

Local anesthesia will be delivered using the conventional syringe

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Lamia Saleh AlGhamdi

Pediatric Dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King AbdulAziz University

Jeddah, Jeddah, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

109-05-23

Identifier Type: -

Identifier Source: org_study_id