ClinicalTrials.Veeva

Menu

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

K

King Abdulaziz University

Status

Completed

Conditions

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

Treatments

Procedure: Inferior Alveolar Nerve Block
Device: Computer-controlled Local Anesthetic delivery system

Study type

Interventional

Funder types

Other

Identifiers

NCT06669039
109-05-23

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

5 to 9 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Conventional Inferior Alveolar nerve block
Active Comparator group
Treatment:
Procedure: Inferior Alveolar Nerve Block
Computer-controlled Intraligamentary local anaesthesia
Experimental group
Treatment:
Device: Computer-controlled Local Anesthetic delivery system

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems