CompletedNot Applicable

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

Saudi Arabia22 participantsStarted 2024-04-24

Plain-language 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.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared a local anesthesia pen to a conventional syringe for reducing pain and dental anxiety — if I struggle with dental anxiety, is there anything from this completed study's findings that might be relevant to how my dentist administers local anesthesia for my treatment?
2Since this trial used the Modified Dental Anxiety Scale (MDAS) to measure anxiety, can you help me understand where I might fall on that scale, and whether the kind of anxiety-reduction approach tested here would realistically make a difference for someone at my level?
3The trial is listed as phase 'NA,' which often means it's comparing delivery methods rather than testing a new drug — does that mean the anesthesia pen used in this study is already available, and is it something you could offer me instead of a conventional syringe?
4Because this trial is already completed, are there published results we could look at together to see whether the anesthesia pen actually showed a meaningful difference in pain scores compared to the standard syringe?
5If the findings from this study suggest one method works better for anxious patients, would it change your recommendation for how my procedure is approached, or are there other factors in my specific case that would matter more?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Score

Timeframe: Baseline and immediate post-procedure

Anxiety using the Modified Dental Anxiety Scale (MDAS)

Timeframe: Baseline and immediate post- procedure

Trial details

NCT IDNCT07656194

SponsorShahad Abudawood

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More Pain trials