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NCT Number: NCT07095946

Effectiveness of Intraligament vs IANB Anesthesia in Children Using Electronic Syringe

This randomized clinical study aims to evaluate the efficacy and pain response of two local anesthesia techniques in pediatric dental treatment using an electronic syringe: ligament anesthesia and inferior alveolar nerve block (IANB). The study applies both techniques to the same sample, where each child undergoes pulpectomy for two different teeth, each under the influence of a different anesthesia technique, during two separate visits.

This study comes in the context of technological advancements in dentistry, which led to the development of computerized syringes as an alternative to traditional syringes. These devices are characterized by precise control of the anesthetic flow rate, as well as containing musical and auditory systems aimed at distracting the child and reducing feelings of fear and anxiety associated with dental treatment. Additionally, computerized syringes provide audible indicators showing the amount of anesthetic injected and support multiple injection modes such as rapid injection, slow injection, and ligament injection, allowing for more efficient and comfortable anesthetic delivery.

Pain intensity will be assessed during three stages of the treatment procedure: during anesthesia administration, during placement of the rubber dam, and during opening of the pulp chambers. Post-procedure pain will also be evaluated using an age-appropriate validated pain scale, along with assessing the satisfaction level of both the children and their parents regarding the use of the electronic syringe as an alternative anesthesia tool. These combined measures aim to provide a comprehensive understanding of the child's experience during dental treatment and contribute to improving anesthesia practices in pediatric dentistry.

Recruiting

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Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Cooperative children based on Frankl Behavior Rating Scale (Positive or Definitely Positive)
  • No clinical signs or symptoms indicating irreversible pulpitis
  • No periodontal ligament inflammation of the tooth to be treated
  • Children aged between 5 and 9 years
  • Children without systemic health problems

Exclusion criteria

  • Children who are uncooperative based on Frankl Behavior Rating Scale (Negative or Definitely Negative)
  • Presence of spontaneous or nocturnal pain
  • Clinical signs and symptoms indicating irreversible pulpitis
  • Presence of periodontal ligament inflammation of the treated tooth
  • Child age older than 10 years or younger than 3 years
  • Children with systemic health problems

Treatment and study plan

Electronic Syringe Intraligament Technique

Device

Use of an electronic syringe device to deliver local anesthesia using the periodontal ligament (PDL) technique in pediatric dental patients

Electronic syringe IANB Technique

Device

Use of an electronic syringe device to deliver local anesthesia via the Inferior Alveolar Nerve Block Technique in pediatric dental patients

Primary outcomes

  1. Success rate of electronic syringe anesthesia in pediatric dental procedures

    Time frame: During procedure (From the start of ligation anesthesia (30 seconds) and block anesthesia (3 to 5 minutes) until reaching the stage of pulp chamber opening)

  2. Success rate of anesthesia technique

    Time frame: During procedure (From the start of ligation anesthesia (30 seconds) and block anesthesia (3 to 5 minutes) until reaching the stage of pulp chamber opening.)

Study contacts

Contact information is provided by the study sponsor or research team.

Abdul Wahab Nourallah, Prof.Dr

CONTACT

[email protected]

+963933395751

Sponsors and collaborators

Lead sponsor

Latakia University

Other

Registry information

Official study title

Comparing the Effectiveness of the Intraligament Anesthesia Technique With the Inferior Alveolar Nerve Block Technique Using the Electronic Syringe in Children: A Random Clinical Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Apr 2, 2026

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.