Comparing a dental anesthesia injector versus the traditional syringe for numbing upper baby molars in children
A Randomized Clinical Trial to Assess Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 8 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 2 sites (Cairo, Cairo Governorate and 1 other locations) |
| Trial ID | NCT07101068 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cairo, Cairo Governorate and 1 other locations
- 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
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.