Actively Recruiting
Electronic vs. Conventional Syringes: Impact on Pediatric Pain and Anxiety
Led by Randa Omer Ahmed Bashir · Updated on 2025-07-31
40
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Electronic vs. Conventional Syringes: Impact on Pediatric Pain and Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 8 years
- Medically healthy (ASA class I)
- Attending their first dental visit
- Have at least one vital primary molar with a deep cavity on each side of the upper jaw
You will not qualify if you...
- Allergy to local anesthesia
- Taking medications that affect salivary flow
- Currently taking corticosteroids
- Parent or guardian refuses to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, Ain Shams university
Cairo, Egypt
Actively Recruiting
Research Team
R
Randa Omer, Master's degree candidate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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