Electronic versus conventional dental syringes for reducing pain and anxiety during local anesthesia in children
Official title: Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children Randomized Clinical Trial
Run by Ain Shams University · NCT07045116 · Data updated 2026-11-12
This test will see if electronic dental syringes cause less pain and anxiety than conventional syringes in children aged 6–8 during local anesthetic injections.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 8 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | July 31, 2025 |
| Study ends | August 30, 2025 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT07045116 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are medically healthy (ASA I) children aged 6–8 attending their first dental visit who have bilateral vital primary molars requiring pulp therapy.
✕Probably not a fit
Children outside the 6–8 age range, medically compromised patients, those taking medications that affect salivary flow, or those allergic to local anesthetics are unlikely to qualify or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This split-mouth randomized controlled trial enrolls 40 children aged 6–8 who need pulp therapy on matching maxillary primary molars. Each child receives electronic anesthesia on one side and a conventional syringe on the other across two visits, with all injections given by the same operator for consistency. The primary outcome is self-reported pain using a Visual Analogue Scale (VAS); secondary outcomes include heart rate, oxygen saturation, and salivary amylase measured by ELISA. Children are blinded with sunglasses and the statistician is blinded, and saliva samples are collected before and after each injection.
Why it matters
Potential benefit: If successful, the electronic syringe could reduce injection pain and anxiety in young children, improving cooperation and the overall dental experience.
How similar studies have gone: Prior randomized studies of computer-controlled or electronic anesthesia devices have reported mixed but often favorable reductions in injection pain compared with conventional syringes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 6-8-year-old children. * Medically free (ASA class I). * Children attending their first dental visit. * The patient should have at least one vital primary molar with deep carious lesion on each side. Exclusion Criteria: * Patient has any allergy to local anesthesia. * Patients take any medications that affect the salivary flow. * Patient taken corticosteroid. * Children whose parents or legal guardians refuse to sign the informed consent.
Where it's running
-
Faculty of Dentistry, Ain Shams university
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Randa Omer, Master's degree candidate
- Email: randaomar@dent.asu.edu.eg
- Phone: +201156298126
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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.