Effectiveness of Intraligament vs IANB Anesthesia in Children Using Electronic Syringe

NCT ID: NCT07095946

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2026-01-20

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electronic Syringe - IANB Technique

Children receive inferior alveolar nerve block (IANB) using an electronic syringe. The injection is performed with controlled speed and pressure to ensure efficient pulpal anesthesia with minimal discomfort.

Group Type: EXPERIMENTAL

Electronic syringe IANB Technique

Intervention Type: DEVICE

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

Electronic Syringe - Intraligamentary Technique

Children receive intraligamentary anesthesia using an electronic syringe. The anesthetic is administered around the tooth ligament to provide localized anesthesia with minimal invasiveness and reduced discomfort.

Group Type: EXPERIMENTAL

Electronic Syringe Intraligament Technique

Intervention Type: DEVICE

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

Interventions

Electronic Syringe Intraligament Technique

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

Intervention Type: DEVICE

Electronic syringe IANB Technique

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tishreen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abdul Wahab Nourallah, Prof.Dr

Role: STUDY_CHAIR

Faculty of Pediatric Dentistry,Tishreen university

Locations

Faculty of Pediatric Dentistry, Tishreen University

Latakia, Latakia Governorate, Syria

Site Status: RECRUITING

Countries

Syria

Central Contacts

Abdul Wahab Nourallah, Prof.Dr

Role: CONTACT

abdulnourallah@tishreen.edu.sy

+963933395751

Facility Contacts

Abdul Wahab Nourallah, Prof.Dr

Role: primary

Abdulnourallah@tishreen.edu.sy

+963933395751

Alaa Jerdy

Role: backup

alaa.jerdy@latakia-univ.edu.sy

+963981609101

Other Identifiers

PED-DENT-Tishreen-University

Identifier Type: -

Identifier Source: org_study_id