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

Comparing the Effectiveness of Several Local Anaesthesic Systems and Thier Effect on Pain Anxiety Behaviour and Vital Signs in Children

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Dental Anxiety; Pediatric Dentistry
• Intervention / Treatment: Device: Conventional syringe injection; Device: Star Pen; Device: Comfort-In; Device: Vibraject

Detailed Description

Local anesthesia is essential for pain control during pediatric dental procedures, yet its administration can cause significant anxiety and distress in children. Recent innovations aim to improve the delivery of anesthesia to make it less painful and more acceptable. This randomized clinical trial investigated and compared four local anesthetic systems: traditional syringe, computer-controlled local anesthetic delivery (CCLAD) using the Star Pen, needle-free injection using Comfort-In, and vibrotactile stimulation with Vibraject.

A total of 112 healthy children aged 6 to 10 years participated in the study. The children were randomly assigned to one of the four anesthesia groups. Pain perception was measured using both the FLACC scale and the Wong-Baker FACES Pain Rating Scale. Anxiety was evaluated using the Venham Picture Test before and during the procedure. Child behavior was rated using the Houpt Behavioral Scale. Vital signs including pulse rate and oxygen saturation were monitored at baseline and during treatment. In addition, satisfaction levels were assessed for both the pediatric patients and their accompanying parents, using child-friendly satisfaction questionnaires and parent-rated Likert scales.

This study aims to identify the anesthesia delivery method that best minimizes pain and anxiety, optimizes behavior, maintains physiological stability, and maximizes satisfaction, thereby enhancing the quality of care in pediatric dentistry.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Latakia, Syrian Arab Republic
    • Faculty Of Dentistry ,Tishreen University, lattakia, Syria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children aged 6-10 years.
2. Physically healthy with no neurological disorders or systemic diseases.
3. Children classified as positive" or "negative-positive" according to the modified Frankl Behavioral Rating Scale.
4. Not taking any sedatives or analgesics drugs

Exclusion Criteria:

1. Uncooperative children who exhibit clear behavioral problems.
2. Children with systemic diseases or disorders that may interfere with local anesthesia.
3. Use of any medications that may affect vital signs or pain response.
4. Presence of infection at the injection site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Syringe Group; 28 Child received local anesthesia using a traditional dental syringe with standard technique.	Device: Conventional syringe injection; Manual injection using a conventional dental syringe and needle to deliver local anesthetic.
Experimental: CCLAD - Star Pen Group; 28 Child received Local anesthesia using the Star Pen computer-controlled delivery system	Device: Star Pen; A computer-controlled local anesthetic delivery system designed to provide slow, controlled injection with improved comfort.
Experimental: Comfort-In - Needle-Free Group; 28 Child received local anesthesia using the Comfort-In needle-free jet injector system.	Device: Comfort-In; A needle-free injection system that delivers anesthetic through high-pressure jet injection, reducing injection-related discomfort.
Experimental: Vibraject - Vibrotactile Device Group; 28 Child received Local anesthesia using a conventional syringe while applying the Vibraject vibrotactile stimulation device.	Device: Vibraject; A vibrating attachment for dental syringes that provides vibrotactile stimulation during injection to distract from pain perception

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level during dental anesthesia and treatment (behavioral assessment)	Procedural pain was assessed using the FLACC scale, which evaluates five behavioral categories (Face, Legs, Activity, Cry, Consolability), each scored from 0 to 2, for a total score range of 0-10. Higher scores indicate greater pain.Scores were assigned by trained observers during the procedure.	From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.
Pain level during dental anesthesia and treatment (self-reported)	Procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain, It's a self-reported scale with six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to point to the face that best described their pain. Higher scores on either scale indicated greater pain intensity.	From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.
Anxiety level during dental anesthesia and treatment	Anxiety was measured using the Venham Picture Test (VPT),The test consists of eight pairs of cartoon images, each pair containing one figure showing a relaxed expression and one showing an anxious expression. Children were asked to choose the picture that best reflected how they felt. Scores ranged from 0 to 8, with higher scores indicating greater anxiety.	From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with anesthesia technique	Patient satisfaction was assessed using a structured questionnaire with two yes/no questions: Are you satisfied with the experience? (Yes/No); Would you like to have the same technique in future visits? (Yes/No) Responses were coded as binary outcomes (Yes = 1, No = 0). Higher total scores indicated greater patient satisfaction.	Immediately after the procedure
Parental satisfaction with anesthesia technique	Parents rated their satisfaction using a Likert scale survey covering perceived child comfort and procedural experience. Scores ranged from 1 (very dissatisfied) to 5 (very satisfied). Higher scores reflected greater parental satisfaction with the anesthesia method used.	Immediately after the procedure
Child behavior during dental procedures	Behavior was assessed using the Houpt Behavior Rating Scale, which evaluates cooperation during dental procedures.The scale is ranging from 1 (poor) to 6 (excellent). Higher scores indicated better cooperation and comfort during treatment.	From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.
Heart rate	Heart rate(beats per minute) was monitored using a pulse oximeter to evaluate the physiological stress response throughout treatment .Readings were recorded at predefined intervals. Increases in heart rate indicated heightened stress or discomfort during the procedure.	From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of pulpotomy, assessed up to 35 minutes.
Oxygen saturation during dental procedures	Oxygen saturation (SpO₂, %) was monitored using a pulse oximeter to evaluate physiological stress response throughout treatment.Readings were recorded at predefined intervals. Decreases in SpO₂ indicated heightened stress or discomfort during the procedure.	From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of pulpotomy, assessed up to 35 minutes.

Collaborators and Investigators

• Sponsor: Tishreen University
• Investigators: Principal Investigator: Abdul Wahab Nourallah, Prof, Faculty of Dentistry, Tishreen University; Principal Investigator: Sara Badr, PHD student, Faculty of Dentistry, Tishreen University

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2024
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: July 22, 2025
• First Submitted That Met QC Criteria: August 2, 2025
• First Posted (Actual): August 6, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pain management; Dental anxiety; Needle-free injection; Local anesthetic delivery systems; Computer-controlled anesthesia; Vibrotactile Devices
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Tishreen U_pedodontic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No