An interventional study of Electronic anesthesia and Conventional anesthesia in Dental Anxiety and Pain Management, sponsored by Randa Omer Ahmed Bashir. Recruiting at 1 site in Egypt. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Randa Omer Ahmed Bashir · Not applicable, Interventional, and Supportive care
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.
This study's planned enrollment of 40 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.
Browse Agnosia studies →This is the only study on the registry with Randa Omer Ahmed Bashir as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Maxillary right primary molar will receive electronic anesthesia
Device: Electronic anesthesia
Maxillary left primary molar will receive conventional anesthesia
Device: Conventional anesthesia
The child will receive electronic anesthesia to the right side of the upper jaw; the pain and anxiety level will be assessed.
Also known as: pen injector
The child will receive conventional anesthesia to the maxillary left side
Also known as: Conventional syringe
Pain Perception
Tool: Visual Analogue Scale (VAS) Scale: 0 (no pain) to 10 (worst possible pain) Purpose: To quantitatively assess the child's subjective pain level post-injection.
Time frame: Timing: Immediately after the administration of local anesthesia (both electronic and conventional)
Heart Rate (HR)
Using Finger-type Pulse Oximeter
Time frame: Immediately before and after the administration of local anesthesia (both electronic and conventional)
Oxygen Saturation
Using Finger-type Pulse Oximeter
Time frame: Immediately before and after both the Electronic and Conventional anesthesia
Salivary amylase level
Using ELIZA kit (Enzyme-Linked Immunosorbent Assay)
Time frame: Before any injection (baseline) - After conventional anesthesia (The saliva samples must be collected up to 30 minutes after the injection) - After electronic anesthesia (The saliva samples must be collected up to 30 minutes after the injection)
Plan to share: No — The Ethical committee refuse to share the patient information because of confidentiality
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.