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

NCT07106138 | Completed DMC

• 1 other identifier: Tishreen U_pedodontic
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety; Pain Management; Pediatric Dentistry

Keywords

Local anesthetic delivery systems; Computer-controlled anesthesia; Needle-free injection; Vibrotactile Devices; Dental anxiety; Pain management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Child behavior during dental procedures

  From the start of local anesthetic injection until completion of pulpotomy, assessed up to 30 minutes.

• 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.

• 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.

• Patient satisfaction with anesthesia technique

  Immediately after the procedure

• Parental satisfaction with anesthesia technique

  Immediately after the procedure

Study Arms (4)

Conventional Syringe Group

ACTIVE COMPARATOR

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

Device: Conventional syringe injection

CCLAD - Star Pen Group

EXPERIMENTAL

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

Device: Star Pen

Comfort-In - Needle-Free Group

EXPERIMENTAL

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

Device: Comfort-In

Vibraject - Vibrotactile Device Group

EXPERIMENTAL

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

Device: Vibraject

Interventions

Conventional syringe injection DEVICE

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

Conventional Syringe Group

Star Pen DEVICE

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

CCLAD - Star Pen Group

Comfort-In DEVICE

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

Comfort-In - Needle-Free Group

Vibraject DEVICE

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

Vibraject - Vibrotactile Device Group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Faculty Of Dentistry ,Tishreen University, lattakia, Syria

Latakia, Syria

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdul Wahab Nourallah, Prof

  Faculty of Dentistry, Tishreen University

  PRINCIPAL INVESTIGATOR

• Sara Badr, PHD student

  Faculty of Dentistry, Tishreen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 6, 2025
• Study Start: April 23, 2024
• Primary Completion: November 29, 2024
• Study Completion: March 10, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)