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

Not Applicable

Completed

• Conditions: Dental Anxiety; Pain Management; Pediatric Dentistry

• Registration Number: NCT07106138
• Lead Sponsor: Tishreen University

Brief 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.

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 Timeline

• Study Start: 2024-04-23
• Primary Completion: 2024-11-29
• Study Completion: 2025-03-10
• Study First Submitted: 2025-07-22
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-02
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain level during dental anesthesia and treatment (behavioral assessment)	From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.	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.
Pain level during dental anesthesia and treatment (self-reported)	From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.	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.
Anxiety level during dental anesthesia and treatment	From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.	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.

Secondary Outcome Measures

Name	Time	Method
Child behavior during dental procedures	From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.	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.
Heart rate	From baseline measurement taken 5 minutes before local anesthetic injection, through the injection, and until completion of pulpotomy, assessed up to 35 minutes.	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.
Patient satisfaction with anesthesia technique	Immediately after the procedure	Patient satisfaction was assessed using a structured questionnaire with two yes/no questions: 1. Are you satisfied with the experience? (Yes/No); 2. 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.
Parental satisfaction with anesthesia technique	Immediately after the procedure	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.
Oxygen saturation during dental procedures	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 (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.

Trial Locations

Locations (1)

Faculty Of Dentistry ,Tishreen University, lattakia, Syria; 🇸🇾 Latakia, Syrian Arab Republic