Comparing a dental anesthesia injector versus the traditional syringe for numbing upper baby molars in children
Official title: A Randomized Clinical Trial to Assess Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients
Run by Ain Shams University · NCT07101068 · Data updated 2026-11-12
This trial tests whether a dental anesthesia injector causes less pain and anxiety than a regular syringe in 6–8-year-old children needing local anesthesia for pulpotomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 8 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 2 sites (Cairo, Cairo Governorate and 1 other locations) |
| Status | Recruiting |
| Started | January 25, 2024 |
| Main results expected | October 1, 2025 |
| Study ends | October 1, 2025 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT07101068 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy, cooperative children aged 6–8 with at least one vital deeply carious maxillary primary molar on each side requiring pulpotomy, no prior local anesthesia experience, and a Frankl behavior score of 3 or 4 are ideal candidates.
✕Probably not a fit
Children with gingivitis, dental abscess, facial trauma, allergy to local anesthetics, recent analgesic use, or who are uncooperative would not qualify and are unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, split-mouth clinical trial in which each child receives both a dental anesthesia injector and a conventional syringe injection on separate visits with random assignment of side. The trial enrolls cooperative, healthy children aged 6 to 8 who have a vital deeply carious maxillary primary molar on each side requiring pulpotomy. Pain and anxiety are measured during and immediately after injections using the Visual Analogue Scale, the Corah Dental Anxiety Scale, and physiologic measures (heart rate and oxygen saturation) recorded by pulse oximeter. The main goal is to compare immediate pain and anxiety responses between the two injection techniques.
Why it matters
Potential benefit: If successful, the injector could reduce pain and anxiety during dental injections and make treatments less distressing for young children.
How similar studies have gone: Prior trials of alternative injection devices in pediatric dentistry have shown mixed but generally promising results for reducing injection pain and anxiety, though evidence is not definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * normal healthy patients (ASA I) * Undergoing the first dental local anesthesia experience * Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla * Score 3 or 4 of Frankl scale of child behavior Exclusion Criteria: * Presence of gingivitis, dental abscess, facial trauma/ injury * Administration of analgesic 48 h before randomization * Presence of allergy from local anesthesia
Where it's running
-
Ain Shams University
Cairo, Cairo Governorate, Egypt Recruiting -
Faculty of dentistry, Ain Shams University
Cairo, Cairo Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Samaa Abdo Mahmoud, Demonstrator
- Email: samaa.abdo@dent.asu.edu.eg
- Phone: 201023004597
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.