RecruitingNot Applicable

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

Egypt40 participantsStarted 2024-01-25

Plain-language 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.

Who can participate

Age range6 Years – 8 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pain during injection

Timeframe: The pain felt by patient will be assessed by Visual analogue scale, Pulse rate and Oxygen saturation at day 1 of anesthesia injection.

Anxiety felt by the patient

Timeframe: the scale will be used at day 1 of anesthesia injection

Trial details

NCT IDNCT07101068

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

Contact for this trial

Samaa Abdo Mahmoud, Demonstrator

201023004597 samaa.abdo@dent.asu.edu.eg

View on ClinicalTrials.gov More Dental Caries trials