About this trial
Study Overview Purpose: To compare pain and anxiety levels in children aged 6-8 during local anesthesia administration using electronic vs. conventional syringes.
Design: Split-mouth randomized controlled trial (RCT) involving 40 children receiving both types of anesthesia during pulp therapy of bilateral maxillary primary molars.
Objectives Primary Outcome: Pain level measured via Visual Analogue Scale (VAS).
Secondary Outcomes:
Physiological markers: heart rate and oxygen saturation via pulse oximetry.
Salivary amylase levels (anxiety biomarker) assessed using ELISA.
Methodology Children are randomly assigned to receive electronic anesthesia on one side and conventional on the other in two separate visits.
Saliva samples are collected before and after each injection.
Double-blind setup: children blinded using sunglasses; statistician also blinded.
Same operator administers all injections for consistency.
Ethical Considerations Written informed consent and assent obtained.
Risks (e.g., systemic toxicity, allergic reactions) minimized via dosage limits and patient monitoring.
Privacy and data security measures in place.
Statistical Analysis Data analyzed using SPSS; significance set at p ≤ 0.05.
Sample size calculated for adequate power (n = 33 minimum; 40 enrolled).
Funding Self-funded.
Clinical Relevance Electronic anesthesia may offer a less painful and anxiety-inducing alternative for pediatric dental patients, potentially improving children's long-term attitude toward dental care.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Electronic anesthesia
- Conventional anesthesia
Treatment groups
Sponsors and collaborators
Randa Omer Ahmed Bashir
Lead sponsor
Ain Shams University
Sponsor institution