Local Anesthesia Pen vs Conventional Syringe In The Treatment of Pain and Dental Anxiety

NCT07656194 | Completed

• 1 other identifier: 160-11- 24
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this is to compare pain and anxiety that may occur during dental anesthesia delivery using conventional dental syringe and the dental anesthesia injector (wireless pain less pen in pediatric dentistry. This is a cross-over randomized clinical trial is to investigate if one technique more efficiant in reducing pain and anaxity. This study could include medically healthy children between the age 6-12 years old requiring restorative dental work. The main question aims to answer \[is/are\]: Is new painless injector pen better or equal to convintional syrange in reducing both pain and anaxity? Randomization will be generated. Children will recive the first dental treatment under eaither systems then a washout period of 14 days will be carries out, then the same patient will recive the dental treatment on the other side using the 2nd device acording to the manufactuurer instructions.

Conditions

Pain; Anxiety

Outcome Measures

Primary Outcomes (2)

• Pain Score

  Wong-Baker FACES Pain Rating Scale, is a self-report measure consisting of a series of six facial expressions (FACES) representing increasing levels of pain. Scores range from 0 to 10, with 0 (happy face) indicating "no hurt" and 10 ( a crying face) indicating "hurts worst". Higher scores represent greater pain intensity and therefore a worse outcome.

  Baseline and immediate post-procedure

• Anxiety using the Modified Dental Anxiety Scale (MDAS)

  The Modified Dental Anxiety Scale is a self-reported measure of dental anxiety consisting of five items, each scored on a 5-point Likert scale. Total scores range from 5 to 25, with 5 indicating no dental anxiety and 25 indicating extreme dental anxiety. Higher scores represent greater dental anxiety and therefore a worse outcome.

  Baseline and immediate post- procedure

Study Arms (2)

Dental anesthesia injector group

EXPERIMENTAL

The dental anesthesia injector

Procedure: Dental anesthesia injector

Conventional Local anaesthesia Syringe

NO INTERVENTION

Conventional Local anaesthesia Syringe

Interventions

Dental anesthesia injector PROCEDURE

Dental anesthesia injector

Dental anesthesia injector group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 6-12 years old
• Medically fit
• Requiring dental restorative procedures (Filling).

You may not qualify if:

• Children younger than 6 years
• Children older than 12 years
• Any significant medical history
• Requiring extensive restorative dental work type such as full crown coverage

Sponsors & Collaborators

• Shahad Abudawood: lead
• King Abdulaziz University: collaborator

Study Sites (1)

King Abdulaziz University

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 18, 2026
• Study Start: April 24, 2024
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)