Effectiveness of Intraligament vs IANB Anesthesia in Children Using Electronic Syringe

Not Applicable

Recruiting

• Conditions: Effectiveness of Anesthesia Using Electronic Syringe in Children in the Context of Endotopy Treatment

• Registration Number: NCT07095946
• Lead Sponsor: Tishreen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-28
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-30
• Study First Posted: 2025-07-31
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-08
• Primary Completion: 2025-09-20
• Study Completion: 2026-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Success rate of electronic syringe anesthesia in pediatric dental procedures	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)
Success rate of anesthesia technique	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.)

Trial Locations

Locations (1)

Faculty of Pediatric Dentistry, Tishreen University; 🇸🇾 Latakia, Syrian Arab Republic