Electronic versus conventional dental syringes for reducing pain and anxiety during local anesthesia in children
Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children Randomized Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 8 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07045116 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Prior randomized studies of computer-controlled or electronic anesthesia devices have reported mixed but often favorable reductions in injection pain compared with conventional syringes.
Eligibility criteria
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 this trial is running
Cairo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.