Electronic vs. Conventional Syringes: Impact on Pediatric Pain and Anxiety

Recruiting now · Not applicable

Conditions studied: Dental Anxiety, Pain Management

In brief

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.

Key facts

Study ID

NCT07045116

Run by

Randa Omer Ahmed Bashir

People needed

40

Starts

2024-12-01

Expected to finish

2025-08-30

Last updated by the study team

2025-07-31

Who can join

Age: 6 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Faculty of Dentistry, Ain Shams university — Cairo, Egypt (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.