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OpenTrials
Completed

NCT Number: NCT07656194

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

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University

Jeddah, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Dental anesthesia injector

Procedure

Dental anesthesia injector

Primary outcomes

  1. Pain Score

    Time frame: Baseline and immediate post-procedure

    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.

  2. Anxiety using the Modified Dental Anxiety Scale (MDAS)

    Time frame: Baseline and immediate post- procedure

    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.

Sponsors and collaborators

Lead sponsor

Shahad Abudawood

Other

Collaborators

  • King Abdulaziz University

Registry information

Official study title

Local Anesthesia Pen vs Conventional Syringe in The Treatment of Pain and Dental Anxiety: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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