RecruitingNot ApplicableNCT07101068

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

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


Sponsor

Ain Shams University

Enrollment

40 participants

Start Date

Jan 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.


Eligibility

Min Age: 6 YearsMax Age: 8 Years

Inclusion Criteria4

  • normal healthy patients (ASA I)
  • Undergoing the first dental local anesthesia experience
  • Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
  • Score 3 or 4 of Frankl scale of child behavior

Exclusion Criteria3

  • Presence of gingivitis, dental abscess, facial trauma/ injury
  • Administration of analgesic 48 h before randomization
  • Presence of allergy from local anesthesia

Interventions

DEVICEDental Anesthesia Injector

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia Injector.

OTHERconventional syringe

Topical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe


Locations(2)

Ain Shams University

Cairo, Cairo Governorate, Egypt

Faculty of dentistry, Ain Shams University

Cairo, Cairo Governorate, Egypt

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NCT07101068