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Completed

NCT Number: NCT06669039

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

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.

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Key information

Conditions

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

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King AbdulAziz University

Jeddah, 21589, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-controlled Local Anesthetic delivery system

Device

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

Inferior Alveolar Nerve Block

Procedure

Local anesthesia will be delivered using the conventional syringe

Primary outcomes

  1. Pain

    Time frame: 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".

  2. Pain

    Time frame: 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"

  3. Stress level

    Time frame: 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

  4. Effectiveness

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

Comparison of Computer Controlled Intra-ligamentary Local Anesthesia and Conventional Inferior Alveolar Nerve Block in Primary Molars Extractions - Randomized Clinical Trail

Acronym: RCT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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