Actively Recruiting

Phase Not Applicable
Age: 6Years - 8Years
All Genders
Healthy Volunteers
ID07101068

A Randomized Clinical Trial to Assess Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

Led by Ain Shams University · Updated on 2025-08-03

40

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a randomized controlled trial to compare pain and anxiety levels in children aged 6 to 8 years undergoing dental treatment with two methods of local anesthesia: a dental anesthesia injector device and the traditional syringe. The study focuses on healthy, cooperative pediatric patients who have deeply carious maxillary primary molars with reversible pulpitis and require buccal infiltration anesthesia before pulpotomy. The goal is to find a method that reduces pain and anxiety during dental injections. Participants will receive topical lidocaine anesthesia for one minute on dried mucosa before local anesthesia administration using either the dental anesthesia injector or the conventional syringe. Each child will experience both injection techniques on separate occasions, with the side of administration assigned randomly (right or left). The study uses a split-mouth design, allowing direct comparison within the same patient. During and immediately after injections, researchers will measure pain using a Visual Analogue Scale, anxiety with the Corah Dental Anxiety Scale, and physiological indicators like heart rate and oxygen saturation via a pulse oximeter. The need for additional anesthesia will also be assessed during the dental visit. The study includes careful monitoring and aims to evaluate which injection method provides a less painful and less anxiety-inducing experience for children.

CONDITIONS

Brief Title

Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

Who Can Participate

Age: 6Years - 8Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Normal healthy patients (ASA I)
  • Undergoing the first dental local anesthesia experience
  • Presence of at least one vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
  • Score 3 or 4 on Frankl scale of child behavior
Not Eligible

You will not qualify if you...

  • Presence of gingivitis, dental abscess, or facial trauma/injury
  • Use of analgesic medication within 48 hours before randomization
  • Known allergy to local anesthesia

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)

Implementation

Duration - Day 1 for each injection method on separate visits

Participants receive local anesthesia injections using both a dental anesthesia injector device and a conventional syringe on separate occasions to compare pain and anxiety levels.

2 visits (in-person), one for each injection method

Trial Site Locations

Total: 2 locations

1

Ain Shams University

Cairo, Cairo Governorate, Egypt

Actively Recruiting

2

Faculty of dentistry, Ain Shams University

Cairo, Cairo Governorate, Egypt

Actively Recruiting

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Research Team

S

Samaa Abdo Mahmoud, Demonstrator

S

Samaa Mahmoud Abd El Saeed, Demonstrator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Local anesthesia with SleeperOne S4 computerized device vs traditional syringe and perceived pain in pediatric patients: a randomized clinical trial.

Marina Consuelo Vitale, Simone Gallo, Maurizio Pascadopoli...

https://pubmed.ncbi.nlm.nih.gov/36627224