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Impact of Local Anesthesia Techniques on Children's Dental Treatment Experience

NCT07106138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-08-11

No results posted yet for this study

Summary

compare the effectiveness of several local anesthetic delivery systems in managing pain, anxiety, behavior, and vital signs among pediatric dental patients. A total of 112 children aged 6 to 10 years were included and randomly assigned to receive local anesthesia via one of the following methods: conventional syringe, computer-controlled local anesthetic delivery system (Star Pen), needle-free injector (Comfort-In), or a vibrotactile device (Vibraject). Pain was assessed using the FLACC and Wong-Baker FACES scales, anxiety with the Venham Picture Test, and behavior with the Houpt scale. Vital signs including pulse and oxygen saturation were recorded during treatment. Additionally, satisfaction levels of both the patients and their parents were evaluated using structured questionnaires and Likert scales. The study seeks to determine which technique provides the most comfortable and effective experience for children undergoing dental procedures.

Conditions

  • Dental Anxiety
  • Pain Management
  • Pediatric Dentistry

Interventions

DEVICE

Conventional syringe injection

Manual injection using a conventional dental syringe and needle to deliver local anesthetic.

DEVICE

Star Pen

A computer-controlled local anesthetic delivery system designed to provide slow, controlled injection with improved comfort.

DEVICE

Comfort-In

A needle-free injection system that delivers anesthetic through high-pressure jet injection, reducing injection-related discomfort.

DEVICE

Vibraject

A vibrating attachment for dental syringes that provides vibrotactile stimulation during injection to distract from pain perception

Sponsors & Collaborators

  • Tishreen University

    lead OTHER

Principal Investigators

  • Abdul Wahab Nourallah, Prof · Faculty of Dentistry, Tishreen University

  • Sara Badr, PHD student · Faculty of Dentistry, Tishreen University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-23
Primary Completion
2024-11-29
Completion
2025-03-10

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07106138 on ClinicalTrials.gov