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

NCT07045116 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-31

No results posted yet for this study

Summary

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.

Conditions

  • Dental Anxiety
  • Pain Management

Interventions

DEVICE

Electronic anesthesia

The child will receive electronic anesthesia to the right side of the upper jaw; the pain and anxiety level will be assessed.

DEVICE

Conventional anesthesia

The child will receive conventional anesthesia to the maxillary left side

Sponsors & Collaborators

  • Randa Omer Ahmed Bashir

    lead OTHER

Principal Investigators

  • Reham Khaled Elghazawy, Associate professor · Faculty of Dentistry, Ain Shams university

  • Nour Wahba, Lecturer/ Pedodontist · Faculty of Dentistry, Ain Shams university

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-07-31
Completion
2025-08-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07045116 on ClinicalTrials.gov