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

Tishreen University

Status: Completed

Conditions: Dental Anxiety; Pediatric Dentistry; Pain Management

Treatments: Device: Conventional syringe injection; Device: Comfort-In; Device: Vibraject; Device: Star Pen

Study type: Interventional

Funder types: Other

Identifiers

NCT07106138

Tishreen U_pedodontic

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 4 patient groups

Conventional Syringe Group

Active Comparator group

Description:

28 Child received local anesthesia using a traditional dental syringe with standard technique.

Treatment:

Device: Conventional syringe injection

CCLAD - Star Pen Group

Experimental group

Description:

28 Child received Local anesthesia using the Star Pen computer-controlled delivery system

Treatment:

Device: Star Pen

Comfort-In - Needle-Free Group

Experimental group

Description:

28 Child received local anesthesia using the Comfort-In needle-free jet injector system.

Treatment:

Device: Comfort-In

Vibraject - Vibrotactile Device Group

Experimental group

Description:

28 Child received Local anesthesia using a conventional syringe while applying the Vibraject vibrotactile stimulation device.

Treatment:

Device: Vibraject