Computer-controlled Intraligamentary Anaesthesia, Inferior Alveolar Nerve Block, Pain Perception, Anesthesia Effectiveness
Conditions
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.
Interventions
DEVICEComputer-controlled Local Anesthetic delivery system
Local anesthesia will be delivered using Computer-controlled Local Anesthetic delivery system.
PROCEDUREInferior Alveolar Nerve Block
Local anesthesia will be delivered using the conventional syringe
Sponsors
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | Immediately after receiving anesthesia | 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. |
| 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 |
Countries
Saudi Arabia
Outcome results
None listed