Actively Recruiting

Phase Not Applicable
Age: 6Years - 8Years
All Genders
Healthy Volunteers
ID07045116

Effectiveness of Electronic Anesthesia Delivery Syringe Versus Conventional Syringe on Pain and Anxiety Perception During Local Anesthetic Injection in Children Randomized Clinical Trial

Led by Randa Omer Ahmed Bashir · Updated on 2025-07-31

40

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating pain and anxiety levels in children aged 6 to 8 years during local anesthesia using electronic versus conventional syringes. The study focuses on children undergoing pulp therapy on both sides of their upper primary molars. This randomized controlled trial aims to understand whether electronic anesthesia devices can reduce discomfort and stress compared to traditional syringes, which is important for improving children's dental experiences and attitudes. Children will receive electronic anesthesia on one side of the upper jaw and conventional anesthesia on the other side during two different visits. The right side will always receive electronic anesthesia, while the left side receives conventional anesthesia. Each injection uses 4% articaine with adrenaline, and topical anesthetic is applied beforehand. The study is double-blinded, with children wearing sunglasses to mask which anesthesia they get, and all injections performed by the same operator for consistency. Participants will have pain measured immediately after each injection using a Visual Analogue Scale (VAS). Researchers will also monitor heart rate and oxygen saturation before and after anesthesia using pulse oximetry. Saliva samples will be collected before and up to 30 minutes after each injection to assess salivary amylase levels as an anxiety marker. The study includes two visits, and all data is analyzed to compare pain and anxiety between the two anesthesia methods.

CONDITIONS

Brief 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 corticosteroids
  • Taking medications that affect saliva flow
  • Parents or guardians refuse to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Two visits over a short period

Participants receive local anesthesia using an electronic syringe on one side of the upper jaw and conventional syringe on the other side during pulp therapy, with pain and anxiety levels assessed.

2 visits (in-person)

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

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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