1. Title and Context Title: Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children.
Submitted by: Randa Omer Ahmed Bashir, for partial fulfillment of a master's degree in Pediatric Dentistry at Ain Shams University.
Supervisors: Assoc. Prof. Dr. Reham Khaled Elghazawy and Dr. Nour Abdelmonem Wahba.
2. Abstract Problem Statement: Local anesthesia causes pain and anxiety, especially in children.
Objective: To compare electronic vs. conventional anesthesia during pulp therapy in 6-8-year-old children.
Design: Split-mouth RCT involving 40 children.
Outcomes:
Primary: Pain measured by Visual Analogue Scale (VAS).
Secondary: Heart rate, oxygen saturation, and salivary amylase (stress biomarker) using ELISA.
3. Background Local anesthesia is a primary source of fear in children due to needle insertion, pressure, and speed of delivery.
Minimizing pain and anxiety is critical for long-term positive dental attitudes.
Electronic anesthesia devices may reduce these discomforts through:
Controlled delivery rate.
Reduced injection pressure.
Numbing tissue ahead of the needle.
4. Research Question (PICOTS Framework) Population: 40 children (6-8 years old).
Intervention: Electronic anesthesia.
Comparator: Conventional anesthesia.
Outcome: Pain (VAS), heart rate, oxygen saturation, salivary amylase.
Time: Two visits.
Setting: Ain Shams University Pediatric Dentistry outpatient clinic (Jan 2024-Jan 2025).
5. Aim and Objectives Aim: To assess pain and anxiety levels during local anesthesia using electronic vs. conventional syringes.
Primary Outcome:
Pain via VAS before and after anesthesia.
Secondary Outcomes:
Heart rate and oxygen saturation using pulse oximetry.
Salivary amylase levels via ELISA test.
6. Hypothesis Null Hypothesis (H0): No difference between electronic and conventional anesthesia in reducing pain and anxiety.
7. Ethical Considerations Risks: Pain, discomfort, self-injury post-procedure, potential allergic reactions.
Risk Minimization:
Proper selection and dosage of anesthetic agents.
Use of topical anesthetic pre-injection.
Postoperative instructions to avoid tissue trauma.
Privacy \& Confidentiality: Anonymized data using patient codes.
Informed Consent: Written consent and assent obtained.
Adverse Events: Monitored and reported with defined procedures.
Sample Disposal: Discarded as biohazardous waste after study completion.
8. Study Design Type: Randomized Controlled Trial (RCT).
Design: Split-mouth, double-blinded.
Blinding:
Patients blinded with sunglasses.
Statistician and assessors blinded to allocation.
Randomization Tool: Sealed Envelope computer-generated randomization.
Allocation Concealment: Handled by a third party.
9. Materials and Methods Study Population
Inclusion Criteria:
6-8 years old.
Medically free (ASA I).
First dental visit.
At least one vital deep carious molar on each side of maxilla.
Exclusion Criteria:
Allergy to local anesthetic.
Use of corticosteroids or drugs affecting saliva.
Declined consent.
Sample Size:
Required Sample: 33 children (based on power analysis).
Final Enrolled: 40 children.
Intervention Procedures:
Visit 1:
One side receives either conventional or electronic anesthesia according to randomization.
(Fact: the right side always received electronic anesthesia, while the left side received conventional anesthesia).
Visit 2:
Opposite side receives the other type of anesthesia.
Procedure:
Topical anesthetic applied 1-2 minutes.
Injection using 4% articaine with 1:100,000 adrenaline.
VAS recorded post-injection.
Heart rate and oxygen saturation measured pre- and post-injection using pulse oximeter.
Saliva samples collected:
Pre-injection (baseline).
Post-injection (after each type).
Saliva stored frozen and tested with ELISA.
10. Bias Minimization Strategies Selection Bias: Controlled through randomization and allocation concealment.
Performance Bias: Double-blind design.
Detection Bias: Blinded outcome assessors.
Attrition Bias: Risk due to single follow-up, acknowledged in design.
Reporting Bias: All outcomes will be reported.
11. Statistical Analysis Software: IBM® SPSS® Statistics Version 26.
Tests:
Categorical data: Chi-square test.
Numerical data:
Normal distribution: Mean ± SD, Paired t-test.
Non-normal distribution: Median and range, Wilcoxon signed-rank test.
Significance Level: p ≤ 0.05.
12. Funding Source: Self-funded.
13. Clinical Relevance Electronic anesthesia offers less pain, better anxiety control, and may become a preferred technique in pediatric dentistry, especially for first-time dental patients.
