Electronic vs. Conventional Syringes: Impact on Pediatric Pain and Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-8
SponsorRanda Omer Ahmed Bashir
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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Electronic anesthesia
DeviceThe child will receive electronic anesthesia to the right side of the upper jaw; the pain and anxiety level will be assessed.
Conventional anesthesia
DeviceThe child will receive conventional anesthesia to the maxillary left side
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Maxillary right primary molarActive comparator 1 intervention
Group B: Maxillary left primary molarActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
Heart Rate (HR)
Using Finger-type Pulse Oximeter
Time frame
Immediately before and after the administration of local anesthesia (both electronic and conventional)2
Oxygen Saturation
Using Finger-type Pulse Oximeter
Time frame
Immediately before and after both the Electronic and Conventional anesthesia3
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Randa Omer Ahmed Bashir
Lead sponsor
Ain Shams University
Sponsor institution
Source ClinicalTrials.gov