Actively Recruiting

Phase Not Applicable
Age: 6Years - 8Years
All Genders
Healthy Volunteers
NCT07045116

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

Age: 6Years - 8Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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